Patent Expiration View
Products whose next patent expiration is in 2025

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.


VYZULTA (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROSTENE BUNOD
NDA Applicant: BAUSCH AND LOMB      NDA No.:
207795  Prod. No.: 001 RX (0.024%)
PatentsExpirationPatented Use
Pat. No. 7629345 DP* Prostaglandin derivatives
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Nov 21, 2017
Jan 5, 2025U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
Pat. No. 7910767 DS* DP* Prostaglandin derivatives
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 21, 2017
Jan 5, 2025U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
Pat. No. 7273946 DS* DP* Prostaglandin derivatives
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 21, 2017
Oct 3, 2025U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
Pat. No. 8058467 DS* Prostaglandin derivatives
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Nov 21, 2017
Feb 21, 2029U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

EDARBI (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL
Drug Classes: angiotensin II receptor blocker
NDA Applicant: AZURITY      NDA No.:
200796  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)
PatentsExpirationPatented Use
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): All strengths: None
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
May 22, 2025 
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 

EDARBYCLOR (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Drug Classes: angiotensin II receptor blocker == thiazide-like diuretic
NDA Applicant: AZURITY      NDA No.:
202331  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL;12.5MG); 002 RX (EQ 40MG MEDOXOMIL;25MG)
PatentsExpirationPatented Use
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist
Claim Types: Composition; Method of use; Formulation; Process
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
Jan 7, 2025U-3: Treatment of hypertension
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None
May 22, 2025 
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2015
Mar 26, 2028 
Pat. No. 9169238 DP* Solid pharmaceutical composition
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Nov 19, 2015
Feb 4, 2030 
Pat. No. 9387249 Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 15, 2019
Jul 1, 2031U-3: Treatment of hypertension

TRILIPIX (CAPSULE, DELAYED RELEASE) (ORAL) CHOLINE FENOFIBRATE [GENERIC AB]
NDA Applicant: ABBVIE      NDA No.:
022224  Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)
PatentsExpirationPatented Use
Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Jan 7, 2025 

UZEDY (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: TEVA      NDA No.:
213586  Prod. No.: 001 RX (50MG/0.14ML (50MG/0.14ML)); 002 RX (75MG/0.21ML (75MG/0.21ML)); 003 RX (100MG/0.28ML (100MG/0.28ML)); 004 RX (125MG/0.35ML (125MG/0.35ML)); 005 RX (150MG/0.42ML (150MG/0.42ML)); 006 RX (200MG/0.56ML (200MG/0.56ML)); 007 RX (250MG/0.7ML (250MG/0.7ML))
PatentsExpirationPatented Use
Pat. No. 8802127 DP* Risperidone-containing PLA:PGA implants and methods of use thereof
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: May 3, 2023
Jan 12, 2025 
Pat. No. 9439905 DP* Risperidone-containing implants and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 3, 2023
Jan 12, 2025U-543: Treatment of schizophrenia
Pat. No. 9717799 DP* Drug-containing implants and methods of use thereof
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 3, 2023
Jan 12, 2025 
Pat. No. 9895447 DP* Drug-containing PLA implants and methods of use thereof
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 3, 2023
Jan 12, 2025 
Pat. No. 9925268 DP* Drug-containing implants and methods of use thereof
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 3, 2023
Jan 12, 2025 
Pat. No. 10736965 DP* Risperidone biodegradable implant
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 3, 2023
Jan 12, 2025 
Pat. No. 8221778 DP* Drug-containing implants and methods of use thereof
Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 3, 2023
Nov 12, 2027U-543: Treatment of schizophrenia
Pat. No. 8741327 DP* Method of maintaining therapeutic risperidone levels in a PLA:PLGA implant
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: May 3, 2023
Nov 12, 2027U-543: Treatment of schizophrenia
Pat. No. 9023897 DP* Biodegradable drug delivery compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: May 3, 2023
Apr 5, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productApr 28, 2026 

BEPREVE (SOLUTION/DROPS) (OPHTHALMIC) BEPOTASTINE BESILATE [GENERIC AT]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.:
022288  Prod. No.: 001 RX (1.5%)
PatentsExpirationPatented Use
Pat. No. 8784789 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 22, 2014
Jan 13, 2025 

ABILIFY (INJECTABLE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.:
021866  Prod. No.: 001 DISC (9.75MG/1.3ML (7.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 7115587 DP* Aripiprazole complex formulation and method
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 21, 2025 *PEDU-764: Treatment of schizophrenia
Pat. No. 7550445 DP* Aripiprazole complex formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 21, 2025 *PED 

SANCUSO (FILM, EXTENDED RELEASE) (TRANSDERMAL) GRANISETRON
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: CUMBERLAND      NDA No.:
022198  Prod. No.: 001 RX (3.1MG/24HR)
PatentsExpirationPatented Use
Pat. No. 7608282 DP* Transdermal granisetron
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 22, 2025U-1011: Use of granisetron transdermal system to treat/prevent chemotherapy induced nausea and vomiting

LOCOID (LOTION) (TOPICAL) HYDROCORTISONE BUTYRATE [GENERIC AB]
NDA Applicant: BAUSCH      NDA No.:
022076  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 7981877 DP* Stabilized steroid composition and method for its preparation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 18, 2011
Jan 23, 2025 

HORIZANT (TABLET, EXTENDED RELEASE) (ORAL) GABAPENTIN ENACARBIL
NDA Applicant: AZURITY      NDA No.:
022399  Prod. No.: 001 RX (600MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 8686034 Crystalline form of .gamma.-aminobutyric acid analog
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 28, 2014
Jan 24, 2025U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
U-1247: Management of postherpetic neuralgia (PHN) in adults
Pat. No. 6818787 DS* DP* [Extended 882 days (2.4 years)]
Prodrugs of GABA analogs, compositions and uses thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Apr 19, 2011; 002: Jan 5, 2012
Apr 6, 2025 
Pat. No. 8114909 Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2012; 002: None
Apr 11, 2026U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
Pat. No. 8026279 DS* DP* Crystalline form of .gamma.-aminobutyric acid analog
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Oct 24, 2011; 002: Jan 5, 2012
Nov 10, 2026 
Pat. No. 8795725 DP* GABA analog prodrug sustained release oral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 27, 2014
Jun 10, 2029U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
U-1247: Management of postherpetic neuralgia (PHN) in adults

NULIBRY (POWDER) (INTRAVENOUS) FOSDENOPTERIN HYDROBROMIDE
Drug Classes: cyclic pyranopterin monophosphate (cPMP)
NDA Applicant: SENTYNL THERAPS INC      NDA No.:
214018  Prod. No.: 001 RX (EQ 9.5MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 7504095 DP* Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Mar 23, 2021
Jan 31, 2025U-3092: Method of treating molybdenum cofactor deficiency type A
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 27, 2025M-286: Information added to clinical pharmacology section to include results from study ORGN001-102
Exclusivity Code: NCE - New chemical entityFeb 26, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2028ODE-342: Indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MOCD) type A

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.:
203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 12, 2013
Feb 5, 2025 
Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 17, 2014
Jan 8, 2027U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less
U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2023
Jan 8, 2027U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 4, 2022
Jan 8, 2027U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes
U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes
U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes
U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 21, 2022
Jan 8, 2027U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less
U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 12, 2013
Feb 15, 2028U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex
U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity
Exclusivity Code: NPP - New patient populationNov 19, 2024 

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.:
203565  Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Feb 2, 2021
Feb 5, 2025 
Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Feb 2, 2021
Jan 8, 2027U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less
U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 28, 2023
Jan 8, 2027U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 4, 2022
Jan 8, 2027U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes
U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes
U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes
U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 21, 2022
Jan 8, 2027U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less
U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 2, 2021
Feb 15, 2028U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity
Exclusivity Code: NPP - New patient populationNov 19, 2024 

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.:
203565  Prod. No.: 003 RX (1GM IRON/20ML (50MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: May 21, 2021
Feb 5, 2025 
Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 003: May 21, 2021
Jan 8, 2027U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less
U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 003: Jun 28, 2023
Jan 8, 2027U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 003: Oct 4, 2022
Jan 8, 2027U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes
U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes
U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes
U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 003: Nov 21, 2022
Jan 8, 2027U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less
U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 003: May 21, 2021
Feb 15, 2028U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity
Exclusivity Code: NPP - New patient populationNov 19, 2024 
Exclusivity Code: NS - New strengthApr 28, 2024 

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.:
203565  Prod. No.: 004 RX (100MG IRON/2ML (50MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 004: Mar 4, 2022
Feb 5, 2025 
Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 004: Mar 4, 2022
Jan 8, 2027U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less
U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 004: Jun 28, 2023
Jan 8, 2027U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 004: Oct 4, 2022
Jan 8, 2027U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes
U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes
U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes
U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 004: Nov 21, 2022
Jan 8, 2027U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less
U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 004: Mar 4, 2022
Feb 15, 2028U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 31, 2026I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity

EPANOVA (CAPSULE) (ORAL) OMEGA-3-CARBOXYLIC ACIDS
NDA Applicant: ASTRAZENECA      NDA No.:
205060  Prod. No.: 001 DISC (1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS)
PatentsExpirationPatented Use
Pat. No. 8383678 DP* Type a gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 3, 2014
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 9012501 DP* Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 20, 2015
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 9132112 DP* Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 30, 2015
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 7960370 DP* [Extended 681 days (1.9 years)]
Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 3, 2014
Dec 20, 2026 
Pat. No. 9050308 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Method of treatment
Pat. Sub. Date(s): 001: Jul 7, 2015
Jan 4, 2033U-1511: Treatment of hypertriglyceridemia
Pat. No. 9050309 DS* DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 7, 2015
Jan 4, 2033 
Pat. No. 10117844 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2018
Jan 4, 2033U-2447: Treatment of severe hypertriglyceridemia (500 mg/dl) in adult patients as an adjunct to diet

KYBELLA (SOLUTION) (SUBCUTANEOUS) DEOXYCHOLIC ACID [GENERIC AP]
NDA Applicant: ABBVIE      NDA No.:
206333  Prod. No.: 001 RX (20MG/2ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 8846066 Methods and related compositions for reduction of fat and skin tightening
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 7, 2015
Feb 8, 2025U-1690: Method for reduction of submental fat
Pat. No. 8298556 Methods and related compositions for the non-surgical removal of fat
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 7, 2015
Aug 3, 2025U-1690: Method for reduction of submental fat
Pat. No. 7622130 Methods and compositions for the non-surgical removal of fat
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 7, 2015
Dec 10, 2027U-1690: Method for reduction of submental fat
Pat. No. 7754230 Methods and related compositions for reduction of fat
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 7, 2015
Dec 10, 2027U-1690: Method for reduction of submental fat
Pat. No. 8461140 DP* Synthetic bile acid compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 7, 2015
Feb 21, 2028 
Pat. No. 8546367 DP* Synthetic bile acid compositions and methods
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: May 27, 2015
Feb 21, 2028U-1690: Method for reduction of submental fat
Pat. No. 8883770 DP* Synthetic bile acid compositions and methods
Claim Types: Composition
Pat. Sub. Date(s): 001: May 27, 2015
Feb 21, 2028 
Pat. No. 9522155 DP* Synthetic bile acid compositions and methods
Claim Types: Composition; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Jan 19, 2017
Feb 21, 2028U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 9636349 Synthetic bile acid compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 29, 2017
Feb 21, 2028U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 9949986 Synthetic bile acid compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 24, 2018
Feb 21, 2028U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 8242294 DS* Synthetic bile acid compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 7, 2015
May 16, 2028 
Pat. No. 8101593 DP* Formulations of deoxycholic acid and salts thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 7, 2015
Mar 2, 2030 
Pat. No. 8367649 DP* Formulations of deoxycholic acid and salts thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 7, 2015
Mar 2, 2030 
Pat. No. 8653058 DP* Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 7, 2015
Mar 2, 2030 
Pat. No. 10500214 DP* Formulations of deoxycholic acid and salts thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 22, 2020
Mar 2, 2030 

ZURAGARD (SOLUTION) (TOPICAL) ISOPROPYL ALCOHOL
NDA Applicant: ZUREX PHARMA      NDA No.:
210872  Prod. No.: 001 OTC (70%)
PatentsExpirationPatented Use
Pat. No. 9011897 DP* Catheter lock solution comprising citrate and a paraben
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 12, 2021
Feb 8, 2025 
Pat. No. 8226971 DP* Catheter lock solution comprising citrate and a paraben
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 12, 2021
May 6, 2025 
Pat. No. 8703828 DP* Antimicrobial compositions and methods of use
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jul 12, 2021
May 23, 2028 
Pat. No. 9629368 Antimicrobial compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 12, 2021
May 23, 2028U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
Pat. No. 8389583 Antimicrobial compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 12, 2021
Aug 9, 2029U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
Pat. No. 10688291 DP* Medical skin applicator apparatus
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jul 12, 2021
Dec 20, 2034U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
Pat. No. 9844654 DP* Medical skin applicator apparatus
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jul 12, 2021
Apr 24, 2036U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 24, 2024M-268: Addition of information to the label regarding a clear product presentation and 26 ml volume products

DUAKLIR PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Drug Classes: anticholinergic == beta-2 adrenergic agonist
NDA Applicant: COVIS      NDA No.:
210595  Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)
PatentsExpirationPatented Use
Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)]
Quinuclidine derivatives and their use as muscarinic M3 receptor ligands
Claim Types: Compound; Process; Method of use
Pat. Sub. Date(s): 001: Apr 24, 2019
Feb 10, 2025U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 24, 2019
Apr 22, 2027 
Pat. No. 10085974 DP* Dosage and formulation
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Apr 24, 2019
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 11000517 DP* Dosage and formulation
Claim Types: Composition; Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Jun 10, 2021
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)

TUDORZA PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: COVIS      NDA No.:
202450  Prod. No.: 001 RX (0.4MG/INH)
PatentsExpirationPatented Use
Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)]
Quinuclidine derivatives and their use as muscarinic M3 receptor ligands
Claim Types: Compound; Process; Method of use
Pat. Sub. Date(s): 001: Jun 28, 2017
Feb 10, 2025U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 17, 2012
Apr 22, 2027 
Pat. No. 10085974 DP* Dosage and formulation
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Oct 26, 2018
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Pat. No. 11000517 DP* Dosage and formulation
Claim Types: Composition; Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Jun 10, 2021
Mar 13, 2029U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)

SCENESSE (IMPLANT) (SUBCUTANEOUS) AFAMELANOTIDE
NDA Applicant: CLIVUNEL INC      NDA No.:
210797  Prod. No.: 001 RX (16MG)
PatentsExpirationPatented Use
Pat. No. 10076555 Methods of inducing melanogenesis in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 6, 2019
Feb 11, 2025U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
Pat. No. 8334265 [Extended 1411 days (3.9 years)]
Method of treatment of photodermatoses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 6, 2019
Mar 11, 2029U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 8, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityOct 8, 2026ODE-270: Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)

HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.:
206627  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG); 005 RX (80MG); 006 RX (100MG); 007 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 11844865 DP* Abuse-proofed oral dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Dec 22, 2023
Feb 13, 2025U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9084816 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 21, 2015
Aug 24, 2027 
Pat. No. 9095614 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 4, 2015
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9095615 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 4, 2015
Aug 24, 2027 
Pat. No. 9486412 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Nov 8, 2016
Aug 24, 2027 
Pat. No. 9486413 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Nov 8, 2016
Aug 24, 2027 
Pat. No. 9492389 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492390 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 17, 2016
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 17, 2016
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9545380 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 17, 2017
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9763933 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 19, 2017
Aug 24, 2027 
Pat. No. 9770416 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 27, 2017
Aug 24, 2027 
Pat. No. 9775809 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 4, 2017
Aug 24, 2027 
Pat. No. 11304908 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Apr 21, 2022
Aug 24, 2027 
Pat. No. 11304909 Tamper resistant dosage forms
Claim Types: Method of use of a product-by-process
Pat. Sub. Date(s): All strengths: Apr 21, 2022
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 8808740 DP* Encased tamper resistant controlled release dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 21, 2014
Dec 21, 2031U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9572779 DP* Encased tamper resistant controlled release dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 21, 2017
Dec 21, 2031 
Pat. No. 9750703 DP* Encased tamper resistant controlled release dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 14, 2017
Dec 21, 2031 
Pat. No. 9861584 DP* Tamper resistant controlled release dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 10, 2018
Dec 21, 2031 
Pat. No. 9872837 DP* Tamper resistant controlled release dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 23, 2018
Dec 21, 2031 

IZERVAY (SOLUTION) (INTRAVITREAL) AVACINCAPTAD PEGOL SODIUM
NDA Applicant: ASTELLAS      NDA No.:
217225  Prod. No.: 001 RX (EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML))
PatentsExpirationPatented Use
Pat. No. 7538211 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 7579456 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 7803931 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025 
Pat. No. 9617546 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 10947544 DS* Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Feb 14, 2025U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 8236773 Aptamer therapeutics useful in the treatment of complement-related disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Nov 11, 2026U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11273171 Methods for treating or preventing ophthalmological conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Jul 11, 2034U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11491176 Methods for treating or preventing ophthalmological conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2023
Jul 11, 2034U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye

INTERMEZZO (TABLET) (SUBLINGUAL) ZOLPIDEM TARTRATE [Has competitive generic]
Drug Classes: gamma-aminobutyric acid (GABA) A receptor positive modulator
NDA Applicant: PURDUE PHARMA      NDA No.:
022328  Prod. No.: 001 DISC (1.75MG); 002 DISC (3.5MG)
PatentsExpirationPatented Use
Pat. No. 7682628 Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 29, 2011; 002: None
Feb 16, 2025U-1194: Method for treating insomnia
Pat. No. 8252809 DP* Compositions for treating insomnia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 28, 2012; 002: None
Feb 16, 2025 
Pat. No. 7658945 DP* Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Nov 29, 2011; 002: None
Apr 15, 2027U-1194: Method for treating insomnia
Pat. No. 8242131 Methods of treating middle-of-the-night insomnia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 15, 2012; 002: None
Aug 20, 2029U-1266: Method of treating middle-of-the-night insomnia

IXEMPRA KIT (INJECTABLE) (INTRAVENOUS) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC      NDA No.:
022065  Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7312237 Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 21, 2025 *PEDU-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer

ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: NOVARTIS      NDA No.:
022383  Prod. No.: 001 DISC (EQ 75MCG BASE)
PatentsExpirationPatented Use
Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)]
Beta2-adrenoceptor agonists
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None
Feb 25, 2025U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Pat. No. 8479730 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2013
Oct 11, 2028 

INCIVEK (TABLET) (ORAL) TELAPREVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: VERTEX PHARMS      NDA No.:
201917  Prod. No.: 001 DISC (375MG)
PatentsExpirationPatented Use
Pat. No. 7820671 DS* DP* [Extended 87 days (0.2 years)]
Peptidomimetic protease inhibitors
Claim Types: Compound; Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jun 20, 2011
Feb 25, 2025 
Pat. No. 8431615 Dose forms
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 29, 2013
May 30, 2028U-1398: Method of treating chronic hepatitis C

RUKOBIA (TABLET, EXTENDED RELEASE) (ORAL) FOSTEMSAVIR TROMETHAMINE
NDA Applicant: VIIV HLTHCARE      NDA No.:
212950  Prod. No.: 001 RX (EQ 600MG BASE)
PatentsExpirationPatented Use
Pat. No. 8461333 DS* Salts of prodrugs of piperazine and substituted piperidine antiviral agents
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 17, 2020
Feb 25, 2025 
Pat. No. 7745625 DS* Prodrugs of piperazine and substituted piperidine antiviral agents
Claim Types: Compound; Process
Pat. Sub. Date(s): 001: Jul 17, 2020
Nov 19, 2027 
Pat. No. 8168615 DP* Prodrugs of piperazine and substituted piperidine antiviral agents
Claim Types: Composition
Pat. Sub. Date(s): 001: Jul 17, 2020
Jul 13, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 2, 2025 

UTIBRON (POWDER) (INHALATION) GLYCOPYRROLATE; INDACATEROL MALEATE
Drug Classes: anticholinergic == antimuscarinic agent == beta-2 adrenergic agonist
NDA Applicant: NOVARTIS      NDA No.:
207930  Prod. No.: 001 DISC (15.6MCG/INH;27.5MCG/INH)
PatentsExpirationPatented Use
Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)]
Beta2-adrenoceptor agonists
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Feb 25, 2025U-1773: Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8479730 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 4, 2015
Oct 11, 2028 
Pat. No. 8182838 DP* Dry powder composition comprising co-jet milled particles for pulmonary inhalation
Claim Types: Product-by-process; Drug in a container; Process
Pat. Sub. Date(s): 001: Dec 4, 2015
Oct 20, 2028 

TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == CYP3A inhibitor == HIV-1 protease inhibitor
NDA Applicant: ABBVIE      NDA No.:
207931  Prod. No.: 001 DISC (12.5MG;75MG;50MG**)
PatentsExpirationPatented Use
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 25, 2025 *PED 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 25, 2025 *PED 
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Sep 10, 2029U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Jun 10, 2030U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Apr 10, 2031U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Jun 9, 2031 
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Oct 10, 2031 *PED 
Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Apr 13, 2032 

SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
021936  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH); 002 RX (EQ 0.00125MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Feb 26, 2025 *PED 
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Nov 26, 2025 *PED 
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Apr 10, 2027 *PED 
Pat. No. 9027967 DP* Device for clamping a fluidic component
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015
Oct 1, 2027 *PED 
Pat. No. 7837235 DP* Device for clamping a fluidic component
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Sep 13, 2028 *PED 
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015
Apr 16, 2031 *PED 

STIOLTO RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
206756  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 10, 2015
Feb 26, 2025 *PED 
Pat. No. 7220742 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 10, 2015
May 12, 2025U-1703: Treatment of respiratory complaints
Pat. No. 8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2015
May 12, 2025U-1702: Treatment of copd
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Jun 10, 2015
May 26, 2025 
Pat. No. 7727984 DS* Medicaments for the treatment of chronic obstructive pulmonary disease
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jun 10, 2015
Jan 19, 2027 
Pat. No. 9027967 DP* Device for clamping a fluidic component
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Jun 10, 2015
Mar 31, 2027 
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 10, 2015
Apr 10, 2027 *PED 
Pat. No. 7837235 DP* Device for clamping a fluidic component
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 10, 2015
Sep 13, 2028 *PED 
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jun 10, 2015
Oct 16, 2030 

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.:
022406  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 4, 2011
Feb 28, 2025 *PEDU-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition
Claim Types: Product-by-process; Process; Method of use
Pat. Sub. Date(s): 001: Sep 14, 2016
May 13, 2025 *PEDU-1167: Prophylaxis of deep vein thrombosis (DVT)
U-2142: Reduction in the risk of recurrence of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients at continued risk for recurrent DVT and/or after completion of initial treatment lasting at least 6 months
U-2640: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding
U-3284: Prophylaxis of thromboembolic diseases in pediatric patients aged 2 years and older with congenital heart disease who have undergone the fontan procedure and a body weight of >=50 kg
Pat. No. 9539218 Prevention and treatment of thromboembolic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 7, 2017
Aug 17, 2034 *PEDU-1957: Prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery, with once daily, rapid-release tablet administered for at least five consecutive days
U-2143: After completion of initial treatment lasting at least 6 months, to reduce the risk of recurrence of deep vein thrombosis and/or pulmonary embolism in certain patients with once daily, rapid-release tablet administered for at least 5 consecutive days
U-2641: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding with once daily, rapid-release tablet administered for at least 5 consecutive days
U-3288: Prophylaxis of PE, DVT and/or stroke in pediatric patients (>=50 kg) aged 2 years and older with congenital heart disease after fontan procedure with once daily, rapid-release tablet administered for at least 5 consecutive days
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 23, 2025 PEDI-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.:
022406  Prod. No.: 002 RX (15MG)
PatentsExpirationPatented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 002: Dec 2, 2011
Feb 28, 2025 *PEDU-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition
Claim Types: Product-by-process; Process; Method of use
Pat. Sub. Date(s): 002: Sep 14, 2016
May 13, 2025 *PEDU-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
U-3286: Treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years with a body weight of 30 kg to 49.9 kg after at least 5 days of initial parenteral anticoagulant treatment
Pat. No. 9539218 Prevention and treatment of thromboembolic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 7, 2017
Aug 17, 2034 *PEDU-1953: Reduce the risk of stroke in patients with nonvalvular atrial fibrillation with once daily, rapid-release tablet administered for at least five consecutive days
U-3289: Treatment of DVT and/or PE and reduction in risk of recurrent DVT and/or PE in pediatric patients (30-49.9 kg) once daily with rapid-release tablet administered for at least 5 consecutive days after at least 5 days parenteral anticoagulant treatment
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 23, 2025 PEDI-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.:
022406  Prod. No.: 003 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 003: Dec 2, 2011
Feb 28, 2025 *PEDU-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition
Claim Types: Product-by-process; Process; Method of use
Pat. Sub. Date(s): 003: Sep 14, 2016
May 13, 2025 *PEDU-1200: Reducing the risk of stroke and systemic embolism
U-1301: Treatment of deep vein thrombosis (DVT)
U-1302: Treatment of pulmonary embolism (PE)
U-3287: Treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years with a body weight of >=50 kg after at least 5 days of initial parenteral anticoagulant treatment
Pat. No. 9539218 Prevention and treatment of thromboembolic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Feb 7, 2017
Aug 17, 2034 *PEDU-1953: Reduce the risk of stroke in patients with nonvalvular atrial fibrillation with once daily, rapid-release tablet administered for at least five consecutive days
U-1954: Treatment of deep vein thrombosis with once daily, rapid-release tablet administered for at least five consecutive days
U-1955: Treatment of pulmonary embolism with once daily, rapid-release tablet administered for at least five consecutive days
U-3285: Treatment of DVT and/or PE and reduction in the risk of recurrent DVT and/or PE in pediatric patients (>=50 kg) once daily with rapid-release tablet administered for at least 5 consecutive days after at least 5 days parenteral anticoagulant treatment
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 23, 2025 PEDI-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.:
022406  Prod. No.: 004 RX (2.5MG)
PatentsExpirationPatented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 004: Nov 8, 2018
Feb 28, 2025 *PED 
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition
Claim Types: Product-by-process; Process; Method of use
Pat. Sub. Date(s): 004: Nov 8, 2018
May 13, 2025 *PEDU-2435: Reduction of risk of major cardiovascular events (CV death, MI, and stroke) in chronic CAD or PAD
U-3205: Reduction of risk of major cardiovascular events (cardiovascular death, myocardial infarction and stroke) in patients with CAD
U-3206: Reduction of risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD
Pat. No. 10828310 Reducing the risk of cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): 004: Dec 9, 2020
Jul 31, 2039 *PEDU-3207: Reduction of risk of cardiovascular death, myocardial infarction, and stroke in patients with CAD by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily
U-3208: Reduction of risk of myocardial infarction and ischemic stroke in patients with PAD by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 23, 2025 PEDI-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (FOR SUSPENSION) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.:
215859  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Feb 28, 2025 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 20, 2025 PED 

XALKORI (CAPSULE) (ORAL) CRIZOTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.:
202570  Prod. No.: 001 RX (200MG); 002 RX (250MG)
PatentsExpirationPatented Use
Pat. No. 8785632 DS* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Mar 1, 2025 
Pat. No. 7230098 DS* [Extended 178 days (0.5 years)]
Aminoheteroaryl compounds as protein kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Sep 14, 2011
Aug 26, 2025 
Pat. No. 7825137 Method of treating abnormal cell growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2011; 002: None
May 12, 2027U-3057: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive
U-3058: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive
U-3403: Method of reversing or inhibiting the progress of unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive in adult and pediatric patients 1 year of age and older
Pat. No. 7858643 DS* DP* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 14, 2011; 002: None
Oct 8, 2029 
Pat. No. 8217057 DS* DP* Polymorphs of a c-MET/HGFR inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Jul 31, 2012; 002: None
Nov 6, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 14, 2024I-852: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive
Exclusivity Code: I - New IndicationJul 14, 2025I-897: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent or refractory inflammatory myofibroblastic tumor (IMT) that is anaplastic lymphoma kinase (ALK) positive
Exclusivity Code: ODE - Orphan drug exclusivityJan 14, 2028ODE-328: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive
Exclusivity Code: ODE - Orphan drug exclusivityJul 14, 2029ODE-407: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive

XALKORI (CAPSULE, PELLETS) (ORAL) CRIZOTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.:
217581  Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 8785632 DS* DP* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Oct 6, 2023
Mar 1, 2025 
Pat. No. 7230098 DS* [Extended 178 days (0.5 years)]
Aminoheteroaryl compounds as protein kinase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Oct 6, 2023
Aug 26, 2025 
Pat. No. 7825137 Method of treating abnormal cell growth
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 6, 2023
May 12, 2027U-3057: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive
U-3058: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive
U-3403: Method of reversing or inhibiting the progress of unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive in adult and pediatric patients 1 year of age and older
Pat. No. 7858643 DS* DP* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Oct 6, 2023
Oct 8, 2029 
Pat. No. 8217057 DS* Polymorphs of a c-MET/HGFR inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): All strengths: Oct 6, 2023
Nov 6, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 14, 2024I-852: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive
Exclusivity Code: I - New IndicationJul 14, 2025I-897: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent or refractory inflammatory myofibroblastic tumor (IMT) that is anaplastic lymphoma kinase (ALK) positive

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.:
208799  Prod. No.: 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 004: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 004: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Aug 25, 2032 *PED 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 004: Aug 2, 2019
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 9415008 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 004: Aug 2, 2019
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 11351317 DP* Drug delivery device with electronics
Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form
Pat. Sub. Date(s): 004: Jun 29, 2022
Aug 10, 2038 *PED 
Pat. No. 11357935 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 004: Jul 13, 2022
Sep 24, 2038 
Pat. No. 11000653 DP* Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 004: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11344685 DP* Drug delivery device with electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Jun 29, 2022
Mar 26, 2040 *PED 
Pat. No. 11439777 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2022
May 24, 2040 
Pat. No. 11464923 DP* Inhaler system
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 004: Nov 10, 2022
Jun 19, 2040 
Pat. No. 11173259 DP* Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 004: Dec 8, 2021
Jan 6, 2041 *PED 
Pat. No. 11266796 DP* Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Apr 7, 2022
Aug 22, 2041 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJan 9, 2025 PEDM-61: Revisions to labeling based on data submitted in response to pediatric written request

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.:
208799  Prod. No.: 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Aug 25, 2032 *PED 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Feb 28, 2036 *PED 
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 11351317 DP* Drug delivery device with electronics
Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form
Pat. Sub. Date(s): All strengths: Jun 29, 2022
Aug 10, 2038 *PED 
Pat. No. 11357935 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jul 13, 2022
Sep 24, 2038 
Pat. No. 11000653 DP* Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11344685 DP* Drug delivery device with electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 29, 2022
Mar 26, 2040 *PED 
Pat. No. 11439777 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2022
May 24, 2040 
Pat. No. 11464923 DP* Inhaler system
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): All strengths: Nov 10, 2022
Jun 19, 2040 
Pat. No. 11173259 DP* Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 8, 2021
Jan 6, 2041 *PED 
Pat. No. 11266796 DP* Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 7, 2022
Aug 22, 2041 *PED 

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.:
208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 001: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jul 3, 2018
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Aug 25, 2032 *PED 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Apr 6, 2035 *PEDU-645: Treatment of asthma
Pat. No. 9415008 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 30, 2017
Apr 6, 2035 *PEDU-645: Treatment of asthma
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJan 9, 2025 PEDM-61: Revisions to labeling based on data submitted in response to pediatric written request

AIRDUO RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.:
208799  Prod. No.: 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 9987229 DP* Process for preparing a medicament
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jul 3, 2018
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Aug 25, 2032 *PED 
Pat. No. 9066957 DP* Dry powder inhaler
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Apr 6, 2035 *PEDU-645: Treatment of asthma

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.:
208798  Prod. No.: 004 RX (0.055MG/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 004: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Aug 25, 2032 *PED 
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 11351317 DP* Drug delivery device with electronics
Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form
Pat. Sub. Date(s): 004: Jun 29, 2022
Aug 10, 2038 *PED 
Pat. No. 11357935 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 004: Jul 13, 2022
Mar 24, 2039 *PED 
Pat. No. 11000653 DP* Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 004: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11344685 DP* Drug delivery device with electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Jun 29, 2022
Mar 26, 2040 *PED 
Pat. No. 11439777 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2022
Nov 24, 2040 *PED 
Pat. No. 11464923 DP* Inhaler system
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 004: Nov 10, 2022
Dec 19, 2040 *PED 
Pat. No. 11173259 DP* Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 004: Dec 8, 2021
Jan 6, 2041 *PED 
Pat. No. 11266796 DP* Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 004: Apr 7, 2022
Aug 22, 2041 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 9, 2025 PED 

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.:
208798  Prod. No.: 005 RX (0.113MG/INH); 006 RX (0.232MG/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Aug 25, 2032 *PED 
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Feb 28, 2036 *PED 
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Jun 14, 2036 *PED 
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 12, 2020
Feb 16, 2037 *PED 
Pat. No. 11351317 DP* Drug delivery device with electronics
Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form
Pat. Sub. Date(s): All strengths: Jun 29, 2022
Aug 10, 2038 *PED 
Pat. No. 11357935 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jul 13, 2022
Mar 24, 2039 *PED 
Pat. No. 11000653 DP* Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2021
Jun 18, 2039 *PED 
Pat. No. 11344685 DP* Drug delivery device with electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 29, 2022
Mar 26, 2040 *PED 
Pat. No. 11439777 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2022
Nov 24, 2040 *PED 
Pat. No. 11464923 DP* Inhaler system
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): All strengths: Nov 10, 2022
Dec 19, 2040 *PED 
Pat. No. 11173259 DP* Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 8, 2021
Jan 6, 2041 *PED 
Pat. No. 11266796 DP* Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 7, 2022
Aug 22, 2041 *PED 

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.:
208798  Prod. No.: 008 DISC (0.03MG/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 008: May 5, 2022
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Sep 26, 2028 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
May 8, 2031 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 008: May 5, 2022
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 008: May 5, 2022
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Jul 13, 2032 *PED 
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Feb 28, 2036 *PED 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Feb 28, 2036 *PED 
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Jun 14, 2036 *PED 
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Feb 16, 2037 *PED 
Pat. No. 11351317 DP* Drug delivery device with electronics
Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form
Pat. Sub. Date(s): 008: Jun 29, 2022
Aug 10, 2038 *PED 
Pat. No. 11357935 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 008: Jul 13, 2022
Mar 24, 2039 *PED 
Pat. No. 11000653 DP* Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 008: May 5, 2022
Jun 18, 2039 *PED 
Pat. No. 11344685 DP* Drug delivery device with electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: Jun 29, 2022
Mar 26, 2040 *PED 
Pat. No. 11439777 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 008: Oct 6, 2022
Nov 24, 2040 *PED 
Pat. No. 11464923 DP* Inhaler system
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 008: Nov 10, 2022
Dec 19, 2040 *PED 
Pat. No. 11173259 DP* Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Jan 6, 2041 *PED 
Pat. No. 11266796 DP* Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 008: May 5, 2022
Aug 22, 2041 *PED 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.:
208798  Prod. No.: 001 DISC (0.055MG/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 001: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Aug 25, 2032 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 9, 2025 PED 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.:
208798  Prod. No.: 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): All strengths: May 10, 2017
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Mar 5, 2019
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 31, 2017
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 13, 2018
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): All strengths: Dec 12, 2018
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): All strengths: Mar 19, 2020
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Aug 25, 2032 *PED 

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.:
208798  Prod. No.: 007 DISC (0.03MG/INH)
PatentsExpirationPatented Use
Pat. No. 9616024 DP* Process for preparing a medicament
Claim Types: Product-by-process; Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Mar 1, 2025 *PED 
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 19, 2025 *PED 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 19, 2025 *PED 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Sep 26, 2028 *PED 
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Aug 14, 2031 *PED 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 18, 2031 *PED 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 18, 2031 *PED 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 18, 2031 *PED 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Dec 28, 2031 *PED 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 007: Aug 5, 2021
Jul 1, 2032 *PED 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Jul 13, 2032 *PED 
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Aug 25, 2032 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthJan 9, 2025 PED 

NEXTSTELLIS (TABLET) (ORAL) DROSPIRENONE; ESTETROL
Drug Classes: progestin
NDA Applicant: MAYNE PHARMA      NDA No.:
214154  Prod. No.: 001 RX (3MG;14.2MG)
PatentsExpirationPatented Use
Pat. No. 7732430 DP* Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: Apr 30, 2021
Mar 2, 2025U-3152: Use by females of reproductive potential to prevent pregnancy
Pat. No. 11793760 DP* Orodispersible dosage unit containing an estetrol component
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 31, 2023
Jun 17, 2036 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 15, 2026 

LYSTEDA (TABLET) (ORAL) TRANEXAMIC ACID [GENERIC AB]
NDA Applicant: AMRING PHARMS      NDA No.:
022430  Prod. No.: 001 RX (650MG)
PatentsExpirationPatented Use
Pat. No. 7947739 DP* Tranexamic acid formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 24, 2011
Mar 4, 2025 
Pat. No. 8022106 Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 20, 2011
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8273795 Tranexamic acid formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 25, 2012
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8487005 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 16, 2013
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8791160 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 25, 2014
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8809394 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2014
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 8957113 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 25, 2015
Mar 4, 2025U-1182: Treatment of cyclic heavy menstrual bleeding
Pat. No. 9060939 DP* Tranexamic acid formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 23, 2015
Mar 4, 2025 

JUXTAPID (CAPSULE) (ORAL) LOMITAPIDE MESYLATE
Drug Classes: microsomal triglyceride transfer protein inhibitor
NDA Applicant: CHIESI      NDA No.:
203858  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE); 004 RX (EQ 30MG BASE) NDA No.: 203858  Prod. No.: 005 DISC (EQ 40MG BASE); 006 DISC (EQ 60MG BASE)
PatentsExpirationPatented Use
Pat. No. 8618135 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 22, 2014; 002: Jan 22, 2014; 003: Jan 22, 2014; 004: May 29, 2015; 005: May 29, 2015; 006: May 29, 2015
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9265758 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 23, 2016
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9364470 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jun 20, 2016
Mar 7, 2025U-1851: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9433617 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 8, 2016
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9861622 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Feb 5, 2018
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 10016404 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2018
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 10555938 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 28, 2020
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 7932268 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2013; 002: None; 003: None; 004: May 29, 2015; 005: May 29, 2015; 006: May 29, 2015
Aug 19, 2027U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses

YUPELRI (SOLUTION) (INHALATION) REVEFENACIN
Drug Classes: anticholinergic
NDA Applicant: MYLAN IRELAND LTD      NDA No.:
210598  Prod. No.: 001 RX (175MCG/3ML)
PatentsExpirationPatented Use
Pat. No. 7491736 Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 7521041 Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Diagnostic or surgical method; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 7550595 DP* Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Composition
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025 
Pat. No. 7585879 DS* DP* Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 7910608 DS* DP* Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025 
Pat. No. 8034946 DP* Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Composition
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025 
Pat. No. 8053448 Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8273894 DP* Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Composition
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025 
Pat. No. 10106503 Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Mar 10, 2025U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 10343995 Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 15, 2019
Mar 10, 2025U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 11247969 DP* Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Drug in a container
Pat. Sub. Date(s): 001: Mar 3, 2022
Mar 10, 2025 
Pat. No. 7288657 DS* Biphenyl compounds useful as muscarinic receptor antagonists
Claim Types: Compound; Process
Pat. Sub. Date(s): 001: Nov 20, 2018
Dec 23, 2025 
Pat. No. 9765028 DS* Crystalline freebase forms of a biphenyl compound
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: May 31, 2019
Jul 14, 2030 
Pat. No. 10550081 DS* Crystalline freebase forms of a biphenyl compound
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Feb 10, 2020
Jul 14, 2030 
Pat. No. 11008289 Crystalline freebase forms of a biphenyl compound
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 20, 2021
Jul 14, 2030U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 11691948 DP* Crystalline freebase forms of a biphenyl compound
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Jul 5, 2023
Jul 14, 2030 
Pat. No. 11858898 DS* DP* Crystalline freebase forms of a biphenyl compound
Claim Types: Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jan 2, 2024
Jul 14, 2030U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8541451 DS* Crystalline freebase forms of a biphenyl compound
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): 001: May 31, 2019
Aug 25, 2031 
Pat. No. 11484531 Methods For Treating Chronic Obstructive Pulmonary Disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 2, 2022
Oct 23, 2039U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 9, 2023 

OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS      NDA No.:
217677  Prod. No.: 001 RX (EQ 50MG BASE)
PatentsExpirationPatented Use
Pat. No. 7951958 DS* Imidazole compounds for the treatment of neurodegenerative disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 1, 2023
Mar 11, 2025 
Pat. No. 7342118 DS* Imidazole compounds for the treatment of neurodegenerative disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 1, 2023
Aug 18, 2025 
Pat. No. 7795447 DS* Imidazole compounds for the treatment of neurodegenerative disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 1, 2023
Aug 18, 2025 
Pat. No. 10590087 DS* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Dec 1, 2023
Aug 9, 2039 
Pat. No. 10710966 DS* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 1, 2023
Aug 9, 2039U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 10941118 DS* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 1, 2023
Aug 9, 2039U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11820748 DP* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 1, 2023
Aug 9, 2039 
Pat. No. 11845732 DS* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 20, 2023
Aug 9, 2039U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11884634 DP* Compositions Of Solid Forms Of (S)-2-(((S)-6,8-difluoro-1,2,3,4- Tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jan 31, 2024
Aug 9, 2039 
Pat. No. 11884635 DP* Solid State Forms Of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide And Uses Thereof
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Jan 31, 2024
Aug 9, 2039 
Pat. No. 11905255 DP* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Feb 21, 2024
Aug 9, 2039 
Pat. No. 11504354 DP* Chlorinated tetralin compounds and pharmaceutical compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2023
Jul 8, 2042 
Pat. No. 11612588 DP* Chlorinated tetralin compounds and pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 1, 2023
Jul 8, 2042U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11807611 DP* Chlorinated tetralin compounds and pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 1, 2023
Sep 8, 2042U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11844780 DP* Chlorinated tetralin compounds and pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 20, 2023
Sep 8, 2042U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11872211 Treatments with nirogacestat
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 17, 2024
May 19, 2043U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11925619 Treatments with nirogacestat
Claim Types: Dosaage regimen; Method of use
Pat. Sub. Date(s): 001: Mar 14, 2024
May 19, 2043U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11925620 Treatments with nirogacestat
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2024
May 19, 2043U-3754: Treatment of adult patients with progressing desmoid tumors
Pat. No. 11938116 Treatments with nirogacestat
Claim Types: Dosaage regimen
Pat. Sub. Date(s): 001: Mar 27, 2024
May 19, 2043U-3754: Treatment of adult patients with progressing desmoid tumors
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 27, 2028 
Exclusivity Code: ODE - Orphan drug exclusivityNov 27, 2030ODE-452: For adult patients with progressing desmoid tumors who require systemic treatment

KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
213756  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7425637 DS* N3 alkylated benzimidazole derivatives as MEK inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: May 6, 2020
Mar 13, 2025 
Pat. No. 8178693 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: May 6, 2020
Mar 13, 2025 
Pat. No. 9156795 DS* DP* Hydrogen sulfate salt
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): All strengths: May 6, 2020
Dec 12, 2026 
Pat. No. 9562017 DS* Hydrogen sulfate salt
Claim Types: Method of use; Product-by-process of a new polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: May 6, 2020
Dec 12, 2026U-2800: Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Pat. No. 11813246 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 7, 2023
Mar 26, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 10, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityApr 10, 2027ODE-288: Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)

MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.:
210498  Prod. No.: 001 RX (15MG)
PatentsExpirationPatented Use
Pat. No. 7777050 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Mar 13, 2025 
Pat. No. 9850229 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030U-2333: Indicated in combination with encorafenib for the treatment of melanoma with a BRAF mutation
Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 27, 2030U-2331: Indicated in combination with encorafenib for the treatment of melanoma
U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jul 4, 2031U-2332: Indicated in combination with encorafenib for the treatment of melanoma mediated by a B-Raf protein kinase
U-3737: MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test
Pat. No. 9562016 DS* DP* Preparation of and formulation comprising a MEK inhibitor
Claim Types: Product-by-process; Formulation; Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Oct 18, 2033 
Pat. No. 9598376 Preparation of and formulation comprising a MEK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Oct 18, 2033U-2330: Method of treating melanoma
Pat. No. 9980944 Preparation of and formulation comprising a MEK inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Oct 18, 2033U-2334: Treatment of melanoma with a BRAF mutation
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 11, 2026I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityJun 27, 2025ODE-194: Encorafenib is indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ABBVIE      NDA No.:
206940  Prod. No.: 001 RX (75MG)
PatentsExpirationPatented Use
Pat. No. 7786158 DS* Compounds as opioid receptor modulators
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 26, 2015
Mar 14, 2025 
Pat. No. 8344011 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 26, 2015
Mar 14, 2025U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 8609709 DS* Compounds as opioid receptor modulators
Claim Types: Compound; New polymorph, salt, or hydrate
Pat. Sub. Date(s): 001: Jun 26, 2015
Mar 14, 2025 
Pat. No. 8772325 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2017
Mar 14, 2025U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9205076 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 30, 2015
Mar 14, 2025U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9700542 DP* Compounds as opioid receptor modulators
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Aug 7, 2017
Mar 14, 2025 
Pat. No. 10213415 DS* Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2019
Mar 14, 2025U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl
Claim Types: New polymorph, salt, or hydrate; Method of use
Pat. Sub. Date(s): 001: Jun 26, 2015
Jul 7, 2028U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 23, 2015
Jul 7, 2028U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline)
Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 14, 2016
Jul 7, 2028U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2017
Jul 7, 2028U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 7741356 DS* DP* [Extended 1068 days (2.9 years)]
Compounds as opioid receptor modulators
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 26, 2015
May 27, 2029 
Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 7, 2017
Mar 14, 2033 
Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 28, 2019
Mar 14, 2033 
Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 3, 2021
Mar 14, 2033 
Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 7, 2021
Mar 14, 2033 
Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 24, 2021
Mar 14, 2033 
Pat. No. 11229627 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 15, 2022
Mar 14, 2033 
Pat. No. 11311516 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 19, 2022
Mar 14, 2033 

VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ABBVIE      NDA No.:
206940  Prod. No.: 002 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7786158 DS* Compounds as opioid receptor modulators
Claim Types: Compound
Pat. Sub. Date(s): 002: Jun 26, 2015
Mar 14, 2025 
Pat. No. 8344011 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2015
Mar 14, 2025U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 8609709 DS* Compounds as opioid receptor modulators
Claim Types: Compound; New polymorph, salt, or hydrate
Pat. Sub. Date(s): 002: Jun 26, 2015
Mar 14, 2025 
Pat. No. 8772325 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 16, 2017
Mar 14, 2025U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9205076 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 30, 2015
Mar 14, 2025U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9700542 DP* Compounds as opioid receptor modulators
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Aug 7, 2017
Mar 14, 2025 
Pat. No. 10213415 DS* Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 21, 2019
Mar 14, 2025U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl
Claim Types: New polymorph, salt, or hydrate; Method of use
Pat. Sub. Date(s): 002: Jun 26, 2015
Jul 7, 2028U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 002: Sep 23, 2015
Jul 7, 2028U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline)
Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 14, 2016
Jul 7, 2028U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): 002: Nov 1, 2017
Jul 7, 2028U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 7741356 DS* DP* [Extended 1068 days (2.9 years)]
Compounds as opioid receptor modulators
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Jun 26, 2015
May 27, 2029 
Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 7, 2017
Mar 14, 2033 
Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 28, 2019
Mar 14, 2033 
Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 3, 2021
Mar 14, 2033 
Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Sep 7, 2021
Mar 14, 2033 
Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 24, 2021
Mar 14, 2033 
Pat. No. 11229627 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 15, 2022
Mar 14, 2033 
Pat. No. 11311516 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 19, 2022
Mar 14, 2033 
Pat. No. 11484527 Opioid receptor modulator dosage formulations
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 22, 2022
Mar 14, 2033U-3475: Reduction of the frequency of abdominal pain and diarrhea, in an inflammatory bowel disease with diarrhea (IBS-D) patient, with eluxadoline twice daily with food

ABILIFY ASIMTUFII (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.:
217006  Prod. No.: 001 RX (720MG/2.4ML (300MG/ML)); 002 RX (960MG/3.2ML (300MG/ML))
PatentsExpirationPatented Use
Pat. No. 8338427 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: May 25, 2023
Mar 15, 2025U-1530: Use of aripiprazole in extended release injectable suspension
Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: May 25, 2023
Jun 29, 2025 
Pat. No. 10517951 DP* Injectable preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 25, 2023
Apr 23, 2033U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11097007 DP* Injectable preparation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 25, 2023
Apr 23, 2033U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11638757 DP* Injectable preparation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 25, 2023
Apr 23, 2033U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia

KAZANO (TABLET) (ORAL) ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
203414  Prod. No.: 001 RX (EQ 12.5MG BASE;500MG); 002 RX (EQ 12.5MG BASE;1GM)
PatentsExpirationPatented Use
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025 
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8900638 DP* Solid preparation comprising alogliptin and metformin hydrochloride
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Dec 18, 2014
May 24, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2026M-300: Revisions to the pediatric use subsection of labeling to include the results from clinical study SYR-322-309, conducted in response to a pediatric written request

NESINA (TABLET) (ORAL) ALOGLIPTIN BENZOATE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
022271  Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE); 003 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025 
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2017
Dec 2, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8697125 DP* Tablet preparation without causing a tableting trouble
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): All strengths: May 27, 2014
Jun 16, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2026M-300: Revisions to the pediatric use subsection of labeling to include the results from clinical study SYR-322-309, conducted in response to a pediatric written request

OSENI (TABLET) (ORAL) ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
022426  Prod. No.: 001 RX (EQ 25MG BASE;EQ 15MG BASE); 002 RX (EQ 25MG BASE;EQ 30MG BASE); 003 RX (EQ 25MG BASE;EQ 45MG BASE); 005 RX (EQ 12.5MG BASE;EQ 30MG BASE) NDA No.: 022426  Prod. No.: 004 DISC (EQ 12.5MG BASE;EQ 15MG BASE**); 006 DISC (EQ 12.5MG BASE;EQ 45MG BASE**)
PatentsExpirationPatented Use
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025 
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8637079 DP* Solid preparation comprising alogliptin and pioglitazone
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 13, 2014
Jun 4, 2029 

LUMIGAN (SOLUTION/DROPS) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE      NDA No.:
022184  Prod. No.: 001 RX (0.01%)
PatentsExpirationPatented Use
Pat. No. 8278353 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2012
Mar 16, 2025 
Pat. No. 8299118 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2012
Mar 16, 2025U-1295: A method of treating a patient with glaucoma or ocular hypertension
Pat. No. 8309605 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2012
Mar 16, 2025U-1293: A method of lowering intraocular pressure in a patient with open angle glaucoma or ocular hypertension
U-1294: Method of treating glaucoma in a patient
Pat. No. 8338479 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: ;Composition; Method of administration
Pat. Sub. Date(s): 001: Dec 26, 2012
Mar 16, 2025U-1295: A method of treating a patient with glaucoma or ocular hypertension
Pat. No. 8524777 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013
Mar 16, 2025U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
Pat. No. 8586630 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 16, 2025U-1458: A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 8772338 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 21, 2014
Mar 16, 2025U-1528: A method of lowering intraocular pressure
Pat. No. 8933120 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 10, 2015
Mar 16, 2025 
Pat. No. 8933127 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 10, 2015
Mar 16, 2025 
Pat. No. 9155716 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 12, 2015
Mar 16, 2025U-1528: A method of lowering intraocular pressure
Pat. No. 9241918 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 24, 2016
Mar 16, 2025U-1814: Method of treating glaucoma or elevated intraocular pressure
Pat. No. 7851504 DS* DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jun 13, 2027 

XTAMPZA ER (CAPSULE, EXTENDED RELEASE) (ORAL) OXYCODONE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
208090  Prod. No.: 001 RX (9MG); 002 RX (13.5MG); 003 RX (18MG); 004 RX (27MG); 005 RX (36MG)
PatentsExpirationPatented Use
Pat. No. 8557291 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 21, 2025 
Pat. No. 7399488 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025 
Pat. No. 7771707 DP* Abuse-deterrent drug formulations
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025 
Pat. No. 8449909 DP* Abuse-deterrent drug formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025 
Pat. No. 8758813 Abuse-deterrent drug formulations
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jun 10, 2025U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9682075 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 20, 2017
Dec 10, 2030U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 10004729 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Jul 10, 2018
Dec 10, 2030U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 10668060 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 3, 2020
Dec 10, 2030U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9737530 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Method of use; Process
Pat. Sub. Date(s): All strengths: Aug 23, 2017
Sep 2, 2036U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9968598 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Process; Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 16, 2018
Sep 2, 2036U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 10188644 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Method of use of a product-by-process; Product-by-process
Pat. Sub. Date(s): All strengths: Jan 29, 2019
Sep 2, 2036U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 10646485 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: May 13, 2020
Sep 2, 2036U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

GLUMETZA (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB3]
Drug Classes: biguanide
NDA Applicant: SANTARUS INC      NDA No.:
021748  Prod. No.: 002 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 7780987 DS* DP* Controlled release dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): 002: None
Mar 23, 2025 

FORTEO (SOLUTION) (SUBCUTANEOUS) TERIPARATIDE
Drug Classes: parathyroid hormone analog
NDA Applicant: LILLY      NDA No.:
021318  Prod. No.: 001 DISC (0.75MG/3ML (0.25MG/ML))
PatentsExpirationPatented Use
Pat. No. 7517334 DP* Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 10, 2014
Mar 25, 2025 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 16, 2023M-302: Information added to labeling regarding osteosarcoma

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.:
022272  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025 
Pat. No. 10407434 DS* Process for preparing oxycodone compositions
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Mar 30, 2025 
Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Composition
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Mar 30, 2025 
Pat. No. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 8894988 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Aug 24, 2027 
Pat. No. 9492389 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9492392 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9763933 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 19, 2017
Aug 24, 2027 
Pat. No. 9770416 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 27, 2017
Aug 24, 2027 
Pat. No. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 4, 2017
Aug 24, 2027 
Pat. No. 11304908 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Apr 21, 2022
Aug 24, 2027 
Pat. No. 11304909 Tamper resistant dosage forms
Claim Types: Method of use of a product-by-process
Pat. Sub. Date(s): All strengths: Apr 21, 2022
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 8894987 DP* Tamper resistant dosage forms
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Mar 29, 2030 

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.:
022272  Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025 
Pat. No. 10407434 DS* Process for preparing oxycodone compositions
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Mar 30, 2025 
Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Composition
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Mar 30, 2025 
Pat. No. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 8894988 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Aug 24, 2027 
Pat. No. 9492389 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9492392 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027 
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9763933 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 19, 2017
Aug 24, 2027 
Pat. No. 9770416 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 27, 2017
Aug 24, 2027 
Pat. No. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 4, 2017
Aug 24, 2027 
Pat. No. 11304908 DP* Tamper resistant dosage forms
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Apr 21, 2022
Aug 24, 2027 
Pat. No. 11304909 Tamper resistant dosage forms
Claim Types: Method of use of a product-by-process
Pat. Sub. Date(s): All strengths: Apr 21, 2022
Aug 24, 2027U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.:
205777  Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG); 003 DISC (20MG;40MG)
PatentsExpirationPatented Use
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025 

PROTONIX (FOR SUSPENSION, DELAYED RELEASE) (ORAL) PANTOPRAZOLE SODIUM [GENERIC AB]
Drug Classes: proton pump inhibitor
NDA Applicant: WYETH PHARMS      NDA No.:
022020  Prod. No.: 001 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 7550153 Pantoprazole multiparticulate formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 30, 2025 *PEDU-859: Erosive esophagitis, hypersecretory conditions including Zollinger-Ellison syndrome, maintenance of healing of erosive esophagitis and reduction of symptoms in patients with GERD
Pat. No. 7553498 Pantoprazole multiparticulate formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 30, 2025 *PEDU-859: Erosive esophagitis, hypersecretory conditions including Zollinger-Ellison syndrome, maintenance of healing of erosive esophagitis and reduction of symptoms in patients with GERD
Pat. No. 7838027 DP* Pantoprazole multiparticulate formulations
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Mar 30, 2025 *PEDU-859: Erosive esophagitis, hypersecretory conditions including Zollinger-Ellison syndrome, maintenance of healing of erosive esophagitis and reduction of symptoms in patients with GERD
Pat. No. 7544370 DP* Pantoprazole multiparticulate formulations
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Dec 7, 2026 *PED 

TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: transthyretin-directed antisense oligonucleotide
NDA Applicant: AKCEA THERAPS      NDA No.:
211172  Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8101743 DS* DP* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 1, 2025 
Pat. No. 8697860 DP* Diagnosis and treatment of disease
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 29, 2031 
Pat. No. 9061044 DS* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 29, 2031 
Pat. No. 9399774 Modulation of transthyretin expression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 29, 2031U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityOct 5, 2025ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

WAINUA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) EPLONTERSEN SODIUM
NDA Applicant: ASTRAZENECA AB      NDA No.:
217388  Prod. No.: 001 RX (EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML))
PatentsExpirationPatented Use
Pat. No. 8101743 DS* DP* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2024
Apr 1, 2025 
Pat. No. 9127276 DS* Conjugated antisense compounds and their use
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2024
May 1, 2034 
Pat. No. 9181549 DS* Conjugated antisense compounds and their use
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2024
May 1, 2034 
Pat. No. 10683499 DS* DP* Compositions and methods for modulating TTR expression
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2024
Aug 25, 2034U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2028 
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2030ODE-461: Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

INVOKANA (TABLET) (ORAL) CANAGLIFLOZIN
NDA Applicant: JANSSEN PHARMS      NDA No.:
204042  Prod. No.: 001 RX (100MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 8222219 [Extended 255 days (0.7 years)]
Glucopyranoside compound
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 16, 2013
Apr 11, 2025U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943788 DS* DP* Glucopyranoside compound
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): 001: Apr 16, 2013; 002: None
Jul 14, 2027 
Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 16, 2013
Dec 3, 2027U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): All strengths: Apr 16, 2013
Feb 26, 2029U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 10617668 DP* Pharmaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 6, 2020
May 11, 2031U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-2794: Treatment of Type 2 diabetes mellitus with 100 mg canagliflozin per day
U-2795: Treatment of Type 2 diabetes mellitus with 300 mg canagliflozin per day
U-2796: Reduction of risk of major adverse cardiovascular events in the treatment of type 2 diabetes mellitus patients with 100 mg canagliflozin per day
U-2797: Reduction of risk of major adverse cardiovascular events in the treatment of type 2 diabetes mellitus patients with 300 mg canagliflozin per day
U-2798: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of type 2 diabetes mellitus patients with 100 mg canagliflozin per day
U-2799: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of type 2 diabetes mellitus patients with 300 mg canagliflozin per day
U-493: Treatment of Type 2 Diabetes Mellitus

KYPROLIS (POWDER) (INTRAVENOUS) CARFILZOMIB [GENERIC AP]
Drug Classes: proteasome inhibitor
NDA Applicant: ONYX PHARMS AMGEN      NDA No.:
202714  Prod. No.: 001 RX (60MG/VIAL); 002 RX (30MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7232818 DS* DP* Compounds for enzyme inhibition
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Apr 14, 2025 
Pat. No. 7491704 Compounds for enzyme inhibition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Apr 14, 2025U-1260: Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy
U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
U-2947: KYPROLIS is indicated in combination with daratumumab plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 8129346 Compounds for enzyme inhibition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Apr 14, 2025U-1260: Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy
U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
U-2947: KYPROLIS is indicated in combination with daratumumab plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 8207125 DS* DP* Compounds for enzyme inhibition
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Apr 14, 2025 
Pat. No. 8207126 DP* Compounds for enzyme inhibition
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Apr 14, 2025 
Pat. No. 8207127 Compounds for enzyme inhibition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Apr 14, 2025U-1260: Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy
U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
U-2947: KYPROLIS is indicated in combination with daratumumab plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 8207297 DS* DP* Compounds for enzyme inhibition
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Apr 14, 2025 
Pat. No. 7417042 DS* DP* [Extended 462 days (1.3 years)]
Compounds for enzyme inhibition
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Jul 20, 2026 
Pat. No. 7737112 DP* Composition for enzyme inhibition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016
Dec 7, 2027 
Pat. No. RE47954 Combination therapy with peptide epoxyketones
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 18, 2022
Oct 21, 2029U-3449: Use in combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): All strengths: Mar 9, 2017
Feb 27, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 20, 2023I-842: Treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with daratumumab and dexamethasone

KYPROLIS (POWDER) (INTRAVENOUS) CARFILZOMIB
Drug Classes: proteasome inhibitor
NDA Applicant: ONYX PHARMS AMGEN      NDA No.:
202714  Prod. No.: 003 RX (10MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7232818 DS* DP* Compounds for enzyme inhibition
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Jun 20, 2018
Apr 14, 2025 
Pat. No. 7491704 Compounds for enzyme inhibition
Claim Types: Method of use
Pat. Sub. Date(s): 003: Jun 20, 2018
Apr 14, 2025U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
U-2947: KYPROLIS is indicated in combination with daratumumab plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 8129346 Compounds for enzyme inhibition
Claim Types: Method of use
Pat. Sub. Date(s): 003: Jun 20, 2018
Apr 14, 2025U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
U-2947: KYPROLIS is indicated in combination with daratumumab plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 8207125 DS* DP* Compounds for enzyme inhibition
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 003: Jun 20, 2018
Apr 14, 2025 
Pat. No. 8207126 DP* Compounds for enzyme inhibition
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 003: Jun 20, 2018
Apr 14, 2025 
Pat. No. 8207127 Compounds for enzyme inhibition
Claim Types: Method of use
Pat. Sub. Date(s): 003: Jun 20, 2018
Apr 14, 2025U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
U-2947: KYPROLIS is indicated in combination with daratumumab plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 8207297 DS* DP* Compounds for enzyme inhibition
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 003: Jun 20, 2018
Apr 14, 2025 
Pat. No. 7417042 DS* DP* [Extended 462 days (1.3 years)]
Compounds for enzyme inhibition
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Jun 20, 2018
Jul 20, 2026 
Pat. No. 7737112 DP* Composition for enzyme inhibition
Claim Types: Formulation
Pat. Sub. Date(s): 003: Jun 20, 2018
Dec 7, 2027 
Pat. No. RE47954 Combination therapy with peptide epoxyketones
Claim Types: Method of use
Pat. Sub. Date(s): 003: Oct 18, 2022
Oct 21, 2029U-3449: Use in combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): 003: Jun 20, 2018
Feb 27, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 20, 2023I-842: Treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with daratumumab and dexamethasone

CABENUVA KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR; RILPIVIRINE
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand transfe == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
212888  Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))
PatentsExpirationPatented Use
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): All strengths: Feb 16, 2021
Apr 21, 2025U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg
Pat. No. 8410103 DS* DP* (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 16, 2021
Apr 28, 2026U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg
Pat. No. 10927129 DS* DP* N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Mar 22, 2021
Apr 28, 2026 
Pat. No. 11389447 Aqueous suspensions of TMC278
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 17, 2022
Jun 30, 2027U-3405: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg by monthly administration of rilpivirine suspension as part of combination therapy
Pat. No. 11224597 DP* Pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 15, 2022
Sep 15, 2031U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJan 31, 2025D-184: New dosing schedule for cabotegravir/rilpivrine injection every 2 months
Exclusivity Code: NCE - New chemical entityJan 21, 2026 
Exclusivity Code: NPP - New patient populationMar 29, 2025 

JULUCA (TABLET) (ORAL) DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
210192  Prod. No.: 001 RX (EQ 50MG BASE;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 20, 2017
Apr 21, 2025U-257: Treatment of HIV infection
Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Dec 20, 2017
Apr 5, 2028 *PED 
Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 20, 2017
Jun 8, 2030 *PED 
Pat. No. 10426780 DS* DP* Antiviral therapy
Claim Types: Formulation; Method of use; Method of administration; Kit
Pat. Sub. Date(s): 001: Oct 25, 2019
Jan 24, 2031U-257: Treatment of HIV infection

ODEFSEY (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
208351  Prod. No.: 001 RX (200MG;EQ 25MG BASE;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Mar 24, 2016
Apr 21, 2025U-257: Treatment of HIV infection
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Mar 24, 2016
Oct 17, 2025 *PED 
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Mar 24, 2016
Feb 15, 2033 *PEDU-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 19, 2016
Feb 15, 2033 *PEDU-257: Treatment of HIV infection

ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN      NDA No.:
021695  Prod. No.: 004 DISC (30MG**)
PatentsExpirationPatented Use
Pat. No. 8026281 Treating metabolic syndrome with fenofibrate
Claim Types: Method of use
Pat. Sub. Date(s): 004: None
Apr 22, 2025U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia
U-1448: Treating severe hypertriglyceridemia

ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN      NDA No.:
021695  Prod. No.: 005 DISC (90MG)
PatentsExpirationPatented Use
Pat. No. 8026281 Treating metabolic syndrome with fenofibrate
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Apr 22, 2025U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia
U-1448: Treating severe hypertriglyceridemia
Pat. No. 9314447 DP* Reduced dose pharmaceutical compositions of fenofibrate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: May 2, 2016
May 31, 2033U-1447: Treating primary hypercholesterolemia and mixed dyslipidemia
U-1448: Treating severe hypertriglyceridemia

VYXEOS (POWDER) (INTRAVENOUS) CYTARABINE; DAUNORUBICIN
Drug Classes: nucleoside metabolic inhibitor == anthracycline topoisomerase inhibitor
NDA Applicant: CELATOR PHARMS      NDA No.:
209401  Prod. No.: 001 RX (100MG;44MG)
PatentsExpirationPatented Use
Pat. No. 8431806 DP* Liposomal formulations of anthracycline agents and cytidine analogs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 30, 2017
Apr 22, 2025U-3147: For the treatment of newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
Pat. No. 8518437 DP* Lipid carrier compositions with enhanced blood stability
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 30, 2017
Jun 7, 2026 
Pat. No. 7850990 DP* Compositions for delivery of drug combinations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 30, 2017
Jan 23, 2027U-3147: For the treatment of newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
Pat. No. 9271931 DP* Compositions for delivery of drug combinations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 30, 2017
Jan 23, 2027 
Pat. No. 8022279 DP*
Claim Types:
Pat. Sub. Date(s): 001: Aug 30, 2017
Sep 14, 2027U-3147: For the treatment of newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
Pat. No. 8092828 Fixed drug ratios for treatment of hematopoietic cancers and proliferative disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 30, 2017
Apr 1, 2029U-3147: For the treatment of newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
Pat. No. 10028912 DP* Method of lyophilizing liposomes
Claim Types: Formulation; Process; Method of administration
Pat. Sub. Date(s): 001: Aug 6, 2018
Oct 15, 2032U-3149: Method of reconstituting a lyophilized liposomal composition for administering cytarabine and daunorubicin to treat newly-diagnosed therapy-related AML (T-AML) or aml with myelodysplasia-related changes (AML-MRC) in patients 1 year and older
U-3150: Method of administering a reconstituted liposomal composition containing cytarabine and daunorubicin to treat newly-diagnosed therapy-related aml (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in patients 1 year and older
Pat. No. 10166184 DP* Method of lyophilizing liposomes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Feb 25, 2019
Oct 15, 2032U-3149: Method of reconstituting a lyophilized liposomal composition for administering cytarabine and daunorubicin to treat newly-diagnosed therapy-related AML (T-AML) or aml with myelodysplasia-related changes (AML-MRC) in patients 1 year and older
Pat. No. 10835492 Method of lyophilizing liposomes
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Dec 8, 2020
Oct 15, 2032U-3150: Method of administering a reconstituted liposomal composition containing cytarabine and daunorubicin to treat newly-diagnosed therapy-related aml (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in patients 1 year and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMar 30, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityAug 3, 2024ODE-287: Treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC)
Exclusivity Code: ODE - Orphan drug exclusivityMar 30, 2028ODE-350: Treatment of newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients ages 1 year and older

ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
203975  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025 
Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014
Nov 21, 2025 *PEDU-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014
Dec 14, 2027 *PEDU-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Jan 9, 2014
Dec 18, 2027 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 20, 2016
Apr 2, 2028 *PED 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Aug 5, 2028 *PED 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Sep 8, 2030 *PED 
Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Nov 29, 2030 
Pat. No. 11090294 Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2021
Nov 29, 2030U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 26, 2014
Apr 11, 2031 *PED 

INCRUSE ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: GLAXO GRP ENGLAND      NDA No.:
205382  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 21, 2014
Apr 27, 2025 
Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 21, 2014
Apr 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 21, 2014
Jul 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 20, 2016
Oct 2, 2027 
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: May 21, 2014
Dec 18, 2027 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: May 21, 2014
Feb 5, 2029 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 26, 2014
Oct 11, 2030 

STENDRA (TABLET) (ORAL) AVANAFIL
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: METUCHEN PHARMS      NDA No.:
202276  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 6656935 DS* DP* [Extended 1687 days (4.6 years)]
Aromatic nitrogen-containing 6-membered cyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 29, 2012
Apr 27, 2025U-155: Treatment of erectile dysfunction
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 18, 2025M-282: Revisions to the labeling to add the results of a clinical study (TA-303) in patients with ED following bilateral nerve-sparing radical prostatectomy

TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
209482  Prod. No.: 001 RX (0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 6, 2017
Apr 27, 2025 
Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 6, 2017
Apr 27, 2025U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application
Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2017
Jul 27, 2025U-2128: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via inhalation
U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2017
Nov 21, 2025 *PEDU-2127: Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
U-2957: Maintenance treatment of asthma in patients 18 yrs and older, or chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2017
Dec 14, 2027 *PEDU-2954: Method of dispensing a combination medicament product from claimed delivery device, for example for the treatment of asthma or COPD
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 6, 2017
Dec 18, 2027 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Oct 6, 2017
Apr 2, 2028 *PED 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Aug 5, 2028 *PED 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Sep 8, 2030 *PED 
Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2017
Nov 29, 2030 
Pat. No. 11090294 Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2021
Nov 29, 2030U-3202: Maintenance treatment of chronic obstructive pulmonary disease (COPD) comprising the once per day administration of trelegy ellipta, 100 mcg fluticasone furoate/62.5 mcg umeclidinium/25 mcg vilanterol
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2017
Apr 11, 2031 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSep 9, 2023I-843: Maintenance treatment of asthma in patients aged 18 years and older

TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
209482  Prod. No.: 002 RX (0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Oct 6, 2020
Apr 27, 2025 
Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Oct 6, 2020
Apr 27, 2025U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application
Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 6, 2020
Jul 27, 2025U-2129: Method of inhibiting the binding of acetylcholine to an acetylcholine receptor in the respiratory tract of a human, comprising contacting the receptor with an effective amount of umeclidinium, via topical application
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 6, 2020
Nov 21, 2025 *PEDU-2957: Maintenance treatment of asthma in patients 18 yrs and older, or chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: Oct 6, 2020
Dec 14, 2027 *PEDU-2954: Method of dispensing a combination medicament product from claimed delivery device, for example for the treatment of asthma or COPD
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 002: Oct 6, 2020
Dec 18, 2027 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 002: Oct 6, 2020
Apr 2, 2028 *PED 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 6, 2020
Aug 5, 2028 *PED 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 6, 2020
Sep 8, 2030 *PED 
Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Formulation
Pat. Sub. Date(s): 002: Oct 6, 2020
Nov 29, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 6, 2020
Apr 11, 2031 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthSep 9, 2023 

INLYTA (TABLET) (ORAL) AXITINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.:
202324  Prod. No.: 001 RX (1MG); 002 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6534524 DS* DP* [Extended 1764 days (4.8 years)]
Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None
Apr 29, 2025 
Pat. No. 8791140 DS* Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Dec 14, 2030 
Pat. No. 10570202 Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Feb 3, 2035U-2844: In combination with pembrolizumab for the first-line treatment of patients with advanced renal cell carcinoma
Pat. No. 10869924 PD-L1 antagonist combination treatments
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2021
Jan 12, 2037U-3044: Axitinib in combination with avelumab for the first-line treatment of patients with advanced renal cell carcinoma

BRILINTA (TABLET) (ORAL) TICAGRELOR [GENERIC AB]
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
022433  Prod. No.: 001 RX (90MG); 002 RX (60MG)
PatentsExpirationPatented Use
Pat. No. RE46276 DS* DP* [Extended 1794 days (4.9 years)]
Triazolo(4,5-D)pyrimidine compounds
Claim Types: Compound; Composition; Process; Method of use
Pat. Sub. Date(s): All strengths: Jan 17, 2017
Apr 30, 2025 *PEDU-1935: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction
U-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction
U-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarction
U-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction
U-2838: Reduction of the rate of a first myocardial infarction or stroke in patients with coronary artery disease at high risk for such events
U-2839: Treatment of myocardial infarction or stroke in patients with coronary artery disease at high risk for such events
U-2988: Reduction of the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack
Pat. No. 8425934 DP* Pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 20, 2013; 002: Sep 30, 2015
Oct 17, 2030 *PED 
Pat. No. 10300065 Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2019
Jul 27, 2036 *PEDU-2541: Reducing the rate of cardiovascular death, myocardial infarction (MI), and stroke in a patient receiving 75-100 mg aspirin daily with a history of MI by administering 60 mg ticagrelor twice daily
U-2542: Reducing the rate of cardiovascular death, myocardial infarction, and stroke in a patient receiving 75-100 mg aspirin daily and having or who had acute coronary syndrome by administering 60 mg ticagrelor twice daily
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 5, 2024 PEDI-848: Reduce the risk of stroke in patients with acute ischemic stroke (NIH stroke scale score <=5) or high-risk transient ischemic attack (TIA)
Exclusivity Code: M - MiscellaneousNov 9, 2025 PEDM-283: Information added to section 8.4 of the labeling to include the result of study HESTIA3

ONIVYDE (INJECTABLE, LIPOSOMAL) (INTRAVENOUS) IRINOTECAN HYDROCHLORIDE
Drug Classes: topoisomerase inhibitor
NDA Applicant: IPSEN      NDA No.:
207793  Prod. No.: 001 RX (EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8703181 Liposomes useful for drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 18, 2015
May 2, 2025U-1434: Treatment of pancreatic cancer
Pat. No. 8992970 DS* DP* Liposomes useful for drug delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 18, 2015
May 2, 2025 
Pat. No. 9724303 DS* DP* Liposomes useful for drug delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 30, 2017
May 2, 2025 
Pat. No. 9730891 Liposomes useful for drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 30, 2017
May 2, 2025U-1848: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
Pat. No. 9782349 DS* DP* Liposomes useful for drug delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 30, 2017
May 2, 2025 
Pat. No. 10722508 DS* DP* Liposomes useful for drug delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 25, 2020
May 2, 2025 
Pat. No. 8329213 DS* DP* [Extended 614 days (1.7 years)]
Liposomes useful for drug delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 18, 2015
Jan 6, 2027 
Pat. No. 8147867 DS* DP* Liposomes useful for drug delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 18, 2015
Aug 29, 2028 
Pat. No. 9339497 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 6, 2016
Jun 12, 2033U-1848: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
Pat. No. 9364473 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 24, 2016
Jun 12, 2033U-1856: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin, in a patient homozygous for the UGT1A1*28 allele
Pat. No. 9452162 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 30, 2016
Jun 12, 2033U-1899: Treatment of pancreatic cancer that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
Pat. No. 9492442 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Dec 2, 2016
Jun 12, 2033U-1848: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
U-1899: Treatment of pancreatic cancer that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
U-1917: Treatment of exocrine pancreatic cancer that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
Pat. No. 9717724 Methods for treating pancreatic cancer using combination therapies
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 30, 2017
Jun 12, 2033U-1848: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
U-2091: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin, in a patient not homozygous for the UGT1A1*28 allele
Pat. No. 10980795 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 11, 2021
Jun 12, 2033U-1848: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
Pat. No. 11369597 Methods for treating pancreatic cancer using combination therapies
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 20, 2022
Jun 12, 2033U-1848: Treatment of metastatic adenocarcinoma of the pancreas that has progressed on gemcitabine-based therapy, in combination with 5-fluorouracil and leucovorin
Pat. No. 11344552 Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin
Claim Types: Method of use; Dosaage regimen; Formulation
Pat. Sub. Date(s): 001: Mar 12, 2024
Aug 19, 2036U-3824: Treatment of metastatic pancreatic adenocarcinoma in combination with oxaliplatin, fluorouracil, and leucovorin
Pat. No. 10456360 DP* Stabilizing camptothecin pharmaceutical compositions
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Nov 25, 2019
Oct 15, 2036 
Pat. No. 10993914 DP* Stabilizing camptothecin pharmaceutical compositions
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: May 11, 2021
Oct 15, 2036 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 13, 2027I-932: In combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma
Exclusivity Code: ODE - Orphan drug exclusivityFeb 13, 2031ODE-463: For first-line treatment of adult patients with metastatic pancreatic adenocarcinoma

AEMCOLO (TABLET, DELAYED RELEASE) (ORAL) RIFAMYCIN SODIUM
Drug Classes: rifamycin antibacterial
NDA Applicant: REDHILL      NDA No.:
210910  Prod. No.: 001 RX (EQ 194MG BASE)
PatentsExpirationPatented Use
Pat. No. 8263120 DP* Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025 
Pat. No. 8486446 DP* Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025 
Pat. No. 8529945 DP* Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025 
Pat. No. 8741948 DP* Oral antimicrobial pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 6, 2018
May 3, 2025U-2448: Treatment of travelers' diarrhea caused by non-invasive strains of escherichia coli in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 16, 2028 GAIN 

BRISDELLE (CAPSULE) (ORAL) PAROXETINE MESYLATE [GENERIC AB]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: SEBELA IRELAND LTD      NDA No.:
204516  Prod. No.: 001 RX (EQ 7.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 7598271 DS* Crystalline paroxetine methane sulfonate
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 11, 2013
May 4, 2025 
Pat. No. 8946251 DS* DP* Method of treating thermoregulatory dysfunction with paroxetine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 9, 2015
Aug 4, 2026U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
Pat. No. 9393237 Method of treating thermoregulatory dysfunction with paroxetine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 11, 2016
Aug 4, 2026U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
Pat. No. 8658663 DS* DP* Method of treating thermoregulatory disfunction with paroxetine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 4, 2014
Apr 6, 2029U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause

PEXEVA (TABLET) (ORAL) PAROXETINE MESYLATE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: SEBELA IRELAND LTD      NDA No.:
021299  Prod. No.: 001 DISC (EQ 10MG BASE); 002 DISC (EQ 20MG BASE); 003 DISC (EQ 30MG BASE); 004 DISC (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 7598271 DS* Crystalline paroxetine methane sulfonate
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
May 4, 2025 

VIZIMPRO (TABLET) (ORAL) DACOMITINIB
NDA Applicant: PFIZER      NDA No.:
211288  Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG)
PatentsExpirationPatented Use
Pat. No. 8623883 4-phenylamino-quinazolin-6-yl-amides
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 25, 2018
May 5, 2025U-1403: First-line treatment of metastatic non small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
Pat. No. 10596162 Method for treating gefitinib resistant cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2022
Feb 2, 2026U-3338: Administering daily a unit dosage of an irreversible EGFR inhibitor covalently binding as claimed for 1st line treatment of gefitinib or erlotinib resistant metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution with T790M mutation
Pat. No. 10603314 Method for treating gefitinib resistant cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2022
Feb 2, 2026U-3337: Administering daily a unit dosage of an irreversible EGFR inhibitor covalently binding as claimed for 1st line treatment of gefitinib of erlotinib resistant metastatic nsclc with EGFR exon 19 deletion or exon 21 L858R substitution
Pat. No. 7772243 DS* DP* 4-phenylamino-quinazolin-6-yl-amides
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Oct 25, 2018
Aug 26, 2028 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 27, 2023 
Exclusivity Code: ODE - Orphan drug exclusivitySep 27, 2025ODE-206: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivitySep 27, 2025ODE-213: Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test

APTIOM (TABLET) (ORAL) ESLICARBAZEPINE ACETATE [GENERIC AB]
NDA Applicant: SUMITOMO PHARMA AM      NDA No.:
022416  Prod. No.: 001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 10675287 Methods of treatment of partial onset seizures using eslicarbazepine acetate
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2020
May 6, 2025U-2041: Treatment of partial-onset seizures
U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures
Pat. No. 10695354 Methods of treatment of partial onset seizures using eslicarbazepine acetate
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 30, 2020
May 6, 2025U-2501: Treatment of partial-onset seizures
U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures
Pat. No. 10702536 Methods of treatment of partial onset seizures using eslicarbazepine acetate
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 7, 2020
May 6, 2025U-2501: Treatment of partial-onset seizures
Pat. No. 11364247 Methods of treatment of partial onset seizures using eslicarbazepine acetate
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 23, 2022
May 6, 2025U-2501: Treatment of partial-onset seizures
U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures
Pat. No. 9206135 DS* Asymmetric catalytic reduction of oxcarbazepine
Claim Types: Compound; Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: May 20, 2016
Apr 21, 2026 
Pat. No. 9643929 DP* Asymmetric catalytic reduction of oxcarbazepine
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 8, 2017
Apr 21, 2026 
Pat. No. 9763954 Therapeutical uses of eslicarbazepine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 10, 2017
Sep 13, 2028U-2123: Treatment of partial-onset seizures in patients with epilepsy who have been previously treated with oxcarbazepine
Pat. No. 9566244 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 8, 2017
Oct 23, 2028 
Pat. No. 10912781 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Oct 23, 2028 
Pat. No. 8372431 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 17, 2030 
Pat. No. 9750747 Treatments involving eslicarbazepine acetate or eslicarbazepine
Claim Types: Method of use; Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2017
Aug 24, 2032U-2041: Treatment of partial-onset seizures
U-2121: Treatment of partial-onset seizures in a patient suffering from or susceptible to absence seizures

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE [GENERIC AB]
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.:
021929  Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH); 002 RX (0.16MG/INH;0.0045MG/INH)
PatentsExpirationPatented Use
Pat. No. 8875699 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2014
May 10, 2025 *PED 
Pat. No. 7587988 DP* Inhaler device counter
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Oct 10, 2026 *PED 
Pat. No. 8387615 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 4, 2013; 002: None
Sep 26, 2027 *PED 
Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 9, 2013
Apr 16, 2029 *PED 
Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Jan 29, 2014
Oct 7, 2029 *PED 

VALTOCO (SPRAY) (NASAL) DIAZEPAM
Drug Classes: benzodiazepine
NDA Applicant: NEURELIS INC      NDA No.:
211635  Prod. No.: 001 RX (5MG/SPRAY); 002 RX (7.5MG/SPRAY); 003 RX (10MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 9642913 DP* Pharmaceutical composition including alkyl glycoside and an anti-seizure agent
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 6, 2020
May 11, 2025 
Pat. No. 10265402 DP* Absorption enhancers for drug administration
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 6, 2020
May 11, 2025 
Pat. No. 8927497 DP* Absorption enhancers for intranasal administration
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Feb 6, 2020
Jul 21, 2025U-2727: Nasal administration of diazepam for treatment of intermittent, stereotypic episodes of frequent seizure activity in patients 6 years of age and older
Pat. No. 8895546 DP* Administration of benzodiazepine compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 6, 2020
Mar 27, 2029 
Pat. No. 11241414 DP* Administration of benzodiazepine compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 1, 2022
Mar 27, 2029 
Pat. No. 11793786 DP* Administration of benzodiazepine compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 31, 2023
Mar 27, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 10, 2027ODE-279: Indicated for the acute tx of intermittent, stereotypic episodes of frequent seizure activity (i.e. seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older

LYMPHOSEEK KIT (INJECTABLE) (INJECTION) TECHNETIUM TC-99M TILMANOCEPT
NDA Applicant: CARDINAL HEALTH 414      NDA No.:
202207  Prod. No.: 001 RX (N/A)
PatentsExpirationPatented Use
Pat. No. 6409990 DS* [Extended 5 years]
Macromolecular carrier for drug and diagnostic agent delivery
Claim Types: Compound; Process; Formulation
Pat. Sub. Date(s): 001: None
May 12, 2025 
Pat. No. 9439985 DP* Compositions for radiolabeling diethylenetriaminepentaacetic acid (DTPA)-dextran
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 14, 2016
Jan 30, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 19, 2024 

ZYDELIG (TABLET) (ORAL) IDELALISIB
Drug Classes: kinase inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
205858  Prod. No.: 001 RX (100MG); 002 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 8980901 5-fluoro-3-phenyl-2[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 10, 2015
May 12, 2025U-1678: For the treatment of patients with CLL, FL, or SLL
Pat. No. 9149477 5-fluoro-3-phenyl-2-[1-(9h-purin-6-ylamino)propyl]-3h-quinazolin-4-one as an inhibitor of human phosphatidylinositol 3-kinase delta
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 3, 2015
May 12, 2025U-1757: Inhibition on PI3K kinase
Pat. No. RE44599 Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 21, 2014
Jul 21, 2025U-1558: For the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma or [relapsed] small lymphocytic lymphoma
U-1615: For the treatment of patients with CLL, FL, or SLL
Pat. No. RE44638 DS* DP* Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Aug 21, 2014
Aug 5, 2025 
Pat. No. 9492449 Therapies for hematologic malignancies
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Mar 11, 2030U-1914: In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL)
Pat. No. 8865730 DS* DP* Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2014
Mar 5, 2033U-1615: For the treatment of patients with CLL, FL, or SLL
Pat. No. 10730879 DS* DP* Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Sep 3, 2020
Mar 5, 2033 
Pat. No. 9469643 DS* Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Claim Types: New polymorph, salt or hydrate; Product-by-process
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Sep 2, 2033 

KUVAN (TABLET) (ORAL) SAPROPTERIN DIHYDROCHLORIDE [GENERIC AB]
Drug Classes: phenylalanine hydroxylase activator
NDA Applicant: BIOMARIN PHARM      NDA No.:
022181  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. RE43797 Methods of administering tetrahydrobiopterin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 3, 2012
May 17, 2025 *PEDU-1156: To reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA)
Pat. No. 7566714 Methods and compositions for the treatment of metabolic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 17, 2025 *PEDU-989: For reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
Pat. No. 7612073 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 17, 2025 *PEDU-1010: To reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetra hydrobiopterin responsive phenylketonuria. KUVAN should be taken orally with food to increase absorption
Pat. No. 7727987 DP* Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: None
May 17, 2025 *PED 
Pat. No. 8067416 Methods and compositions for the treatment of metabolic disorders
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 9, 2011
May 17, 2025 *PEDU-989: For reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
Pat. No. 8318745 DP* Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: None
May 17, 2025 *PED 
Pat. No. 9433624 Methods and compositions for the treatment of metabolic disorders
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2016
May 17, 2025 *PEDU-1589: Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
Pat. No. 7566462 DP* Stable tablet formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 16, 2026 *PED 
Pat. No. 8003126 Stable tablet formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 19, 2011
May 16, 2026 *PED 

KUVAN (POWDER) (ORAL) SAPROPTERIN DIHYDROCHLORIDE [GENERIC AB]
Drug Classes: phenylalanine hydroxylase activator
NDA Applicant: BIOMARIN PHARM      NDA No.:
205065  Prod. No.: 001 RX (100MG/PACKET); 002 RX (500MG/PACKET)
PatentsExpirationPatented Use
Pat. No. RE43797 Methods of administering tetrahydrobiopterin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2014; 002: Nov 24, 2015
May 17, 2025 *PEDU-1590: KUVAN is indicated to reduce blood phenylalanine levels in patients with hyperphenylalaninemia
Pat. No. 7566714 Methods and compositions for the treatment of metabolic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2014; 002: Nov 24, 2015
May 17, 2025 *PEDU-1589: Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
Pat. No. 7612073 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2014; 002: Nov 24, 2015
May 17, 2025 *PEDU-1010: To reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetra hydrobiopterin responsive phenylketonuria. KUVAN should be taken orally with food to increase absorption
Pat. No. 8067416 Methods and compositions for the treatment of metabolic disorders
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 14, 2014; 002: Nov 24, 2015
May 17, 2025 *PEDU-1589: Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
Pat. No. 9433624 Methods and compositions for the treatment of metabolic disorders
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Oct 5, 2016
May 17, 2025 *PEDU-1589: Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
Pat. No. 9216178 DP* Dry blend formulation of tetrahydrobiopterin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 15, 2016
May 1, 2033 *PED 

OLYSIO (CAPSULE) (ORAL) SIMEPREVIR SODIUM
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.:
205123  Prod. No.: 001 DISC (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 7671032 DS* DP* [Extended 801 days (2.2 years)]
HCV NS-3 serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: None
May 19, 2025 
Pat. No. 8349869 DS* DP* Macrocylic inhibitors of hepatitis C virus
Claim Types: Compound; Formulation; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None
Jul 28, 2026U-1467: Method of treating hepatitis C
Pat. No. 8741926 DS* Macrocyclic inhibitors of hepatitis C virus
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 1, 2014
Jul 28, 2026U-1467: Method of treating hepatitis C
Pat. No. 8754106 DS* Macrocyclic inhibitors of hepatitis C virus
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 1, 2014
Jul 28, 2026U-1467: Method of treating hepatitis C
Pat. No. 9040562 DS* DP* Macrocyclic inhibitors of hepatitis C virus
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 23, 2015
Jul 28, 2026U-1467: Method of treating hepatitis C
Pat. No. 9353103 Macrocyclic inhibitors of hepatitis C virus
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 17, 2016
Jul 28, 2026U-1467: Method of treating hepatitis C
Pat. No. 9623022 Macrocyclic inhibitors of hepatitis C virus
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 17, 2017
Jul 28, 2026U-1467: Method of treating hepatitis C
Pat. No. 9856265 DS* DP* Macrocyclic inhibitors of hepatitis C virus
Claim Types: Compound; Method of use; Formulation; Composition
Pat. Sub. Date(s): 001: Feb 1, 2018
Jul 28, 2026U-1467: Method of treating hepatitis C
Pat. No. 8148399 DS* DP* Macrocyclic inhibitors of hepatitis C virus
Claim Types: Compound; Composition; Process; Method of use
Pat. Sub. Date(s): 001: None
Sep 5, 2029U-1467: Method of treating hepatitis C

PROAIR DIGIHALER (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
205636  Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 19, 2025 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 6, 2020
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Mar 26, 2028 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 002: Jan 9, 2019
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jun 28, 2031 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 002: Mar 19, 2020
Jan 1, 2032 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Jan 13, 2032 
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Jan 9, 2019
Aug 28, 2035 
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 9, 2019
Aug 28, 2035 
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Mar 18, 2021
Dec 14, 2035 
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Mar 12, 2020
Aug 16, 2036 
Pat. No. 11351317 DP* Drug delivery device with electronics
Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form
Pat. Sub. Date(s): 002: Jun 29, 2022
Feb 10, 2038 
Pat. No. 11357935 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 13, 2022
Sep 24, 2038 
Pat. No. 11000653 DP* Inhaler
Claim Types: Part of a dosage form; Device; Method of use
Pat. Sub. Date(s): 002: Jun 10, 2021
Dec 18, 2038 
Pat. No. 11344685 DP* Drug delivery device with electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Jun 29, 2022
Sep 26, 2039 
Pat. No. 11439777 DP* Drug delivery device with electronics
Claim Types: Device
Pat. Sub. Date(s): 002: Oct 6, 2022
May 24, 2040 
Pat. No. 11464923 DP* Inhaler system
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 002: Nov 10, 2022
Jun 19, 2040 
Pat. No. 11173259 DP* Drug delivery device with electronics and power management
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 8, 2021
Jul 6, 2040 
Pat. No. 11266796 DP* Inhalation device with integrated electronics
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Apr 7, 2022
Feb 22, 2041 

PROAIR RESPICLICK (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
205636  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 8, 2016
May 19, 2025 
Pat. No. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
May 19, 2025 
Pat. No. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 28, 2015
Mar 26, 2028 
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2017
May 18, 2031 
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 14, 2018
May 18, 2031 
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form; Device
Pat. Sub. Date(s): 001: Dec 12, 2018
May 18, 2031 
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2016
Jun 28, 2031 
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Mar 19, 2020
Jan 1, 2032 
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2016
Jan 13, 2032 

FYCOMPA (TABLET) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: CATALYST PHARMS      NDA No.:
202834  Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (6MG); 004 RX (8MG); 005 RX (10MG); 006 RX (12MG)
PatentsExpirationPatented Use
Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 19, 2012
May 23, 2025U-106: Treatment of epilepsy
U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy
U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older
U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older
Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Aug 6, 2014
Jul 1, 2026 

FYCOMPA (SUSPENSION) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: CATALYST PHARMS      NDA No.:
208277  Prod. No.: 001 RX (0.5MG/ML)
PatentsExpirationPatented Use
Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 27, 2016
May 23, 2025U-106: Treatment of epilepsy
U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy
U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older
U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older
Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: May 27, 2016
Jul 1, 2026 

ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
Drug Classes: transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC      NDA No.:
210922  Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8334373 DS* DP* Nuclease resistant double-stranded ribonucleic acid
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Sep 6, 2018
May 27, 2025 
Pat. No. 8642076 DP* Lipid containing formulations
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018
Oct 3, 2027 
Pat. No. 8058069 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018
Apr 15, 2029 
Pat. No. 8492359 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018
Apr 15, 2029 
Pat. No. 8822668 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Apr 15, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 9364435 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Apr 15, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 11141378 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 9, 2021
Apr 15, 2029 
Pat. No. 8168775 DS* DP* Compositions and methods for inhibiting expression of transthyretin
Claim Types: Compound; Composition; Intermediate; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Oct 20, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 8741866 Compositions and methods for inhibiting expression of transthyretin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Oct 20, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 9234196 DP* Compositions and methods for inhibiting expression of transthyretin
Claim Types: Formulation; Intermediate; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Oct 20, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 10240152 DS* DP* Compositions and methods for inhibiting expression of transthyretin
Claim Types: Formulation claimed by its inherent performace characteristics; Method of Use claimed by its inherent performace characteristics; Composition
Pat. Sub. Date(s): 001: Sep 3, 2021
Oct 20, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 8802644 DP* Lipid formulation
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Oct 21, 2030U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 8158601 DP* Lipid formulation
Claim Types: Compound; Composition; Formulation; Method of administration
Pat. Sub. Date(s): 001: Sep 6, 2018
Nov 10, 2030U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 11079379 DS* DP* Methods of treating transthyretin (TTR) mediated amyloidosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 3, 2021
Aug 27, 2035U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityAug 10, 2025ODE-197: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH BIOPHARMA      NDA No.:
022468  Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 31, 2025U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma
Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None
May 31, 2025U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

DIPRIVAN (INJECTABLE) (INJECTION) PROPOFOL [GENERIC AB]
Drug Classes: general anesthetic
NDA Applicant: FRESENIUS KABI USA      NDA No.:
019627  Prod. No.: 002 RX (10MG/ML)
PatentsExpirationPatented Use
Pat. No. 8476010 DS* DP* Propofol formulations with non-reactive container closures
Claim Types: Drug in a container
Pat. Sub. Date(s): 002: Jul 2, 2013
Jun 1, 2025 *PED 

CIPRODEX (SUSPENSION/DROPS) (OTIC) CIPROFLOXACIN; DEXAMETHASONE [GENERIC AB]
Drug Classes: fluoroquinolone antibacterial == corticosteroid
NDA Applicant: SANDOZ      NDA No.:
021537  Prod. No.: 001 RX (0.3%;0.1%)
PatentsExpirationPatented Use
Pat. No. 8846650 DP* Method of treating middle ear infections
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 3, 2014
Jun 4, 2025U-1578: Treatment of acute otitis media

BRIXADI (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: partial opioid agonist
NDA Applicant: BRAEBURN      NDA No.:
210136  Prod. No.: 001 RX (8MG/0.16ML (50MG/ML)); 002 RX (16MG/0.32ML (50MG/ML)); 003 RX (24MG/0.48ML (50MG/ML)); 004 RX (32MG/0.64ML (50MG/ML)); 005 RX (64MG/0.18ML (356MG/ML)); 006 RX (96MG/0.27ML (356MG/ML)); 007 RX (128MG/0.36ML (356MG/ML))
PatentsExpirationPatented Use
Pat. No. 8545832 DP* Lipid depot formulations
Claim Types: Formulation; Method of administration; Process; Method of use
Pat. Sub. Date(s): All strengths: Jun 6, 2023
Jun 6, 2025U-3619: A method of delivery of a bioactive agent by subcutaneous injection. a method of treatment of a human for addiction
Pat. No. 8236755 DP* Opioid depot formulations
Claim Types: Formulation; Method of administration; Process; Method of use
Pat. Sub. Date(s): All strengths: Jun 6, 2023
Jul 31, 2026U-3620: A method of delivery of an opioid bioactive agent. a method of treatment or prophylaxis of a human or non-human animal for the treatment of opioid addiction and/or the symptoms of opioid withdrawal
Pat. No. 8236292 DP* Liquid depot formulations
Claim Types: Formulation; Method of administration; Process; Method of use
Pat. Sub. Date(s): All strengths: Jun 6, 2023
Jan 10, 2027U-3619: A method of delivery of a bioactive agent by subcutaneous injection. a method of treatment of a human for addiction
Pat. No. 9937164 DP* Opioid formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: Jun 6, 2023
Jul 26, 2032U-3618: A method of sustained delivery of buprenorphine to a human or non-human animal body. a method for treatment for opioid maintenance therapy
Pat. No. 10912772 Opioid formulations
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jun 6, 2023
Jul 26, 2032U-3617: A method of administering an opioid maintenance treatment comprising buprenorphine. a method of treating opioid withdrawal using an opioid maintenance treatment comprising buprenorphine
Pat. No. 11110084 DP* Opioid formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: Jun 6, 2023
Jul 26, 2032U-3616: A method of administering an opioid maintenance treatment comprising buprenorphine
Pat. No. 11135215 DP* Opioid formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 6, 2023
Jul 26, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 23, 2026 

MEKINIST (SOLUTION) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.:
217513  Prod. No.: 001 RX (EQ 0.05MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 8835443 Pyrimidine compound and medical use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 4, 2023
Jun 10, 2025U-3564: MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy
Pat. No. 7378423 DS* DP* [Extended 718 days (2 years)]
Pyrimidine compound and medical use thereof
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: May 4, 2023
May 29, 2027 
Pat. No. 8703781 DS* DP* Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 4, 2023
Oct 15, 2030U-3564: MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 16, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityMar 16, 2030ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy

FILSUVEZ (GEL) (TOPICAL) BIRCH TRITERPENES
NDA Applicant: CHIESI      NDA No.:
215064  Prod. No.: 001 RX (10%)
PatentsExpirationPatented Use
Pat. No. 8828444 DP* Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Feb 16, 2024
Jun 21, 2025 
Pat. No. 9352041 Use of an oleogel containing triterpene for healing wounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2024
Nov 24, 2030U-3811: Use of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa
Pat. No. 9827214 Use of an oleogel containing triterpene for healing wounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2024
Nov 24, 2030U-3811: Use of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa
Pat. No. 11083733 DP* Betulin-containing birch bark extracts and their formulation
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Feb 16, 2024
Jan 4, 2039 
Pat. No. 11266660 Betulin-containing birch bark extracts and their formulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2024
Jan 4, 2039U-3811: Use of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 18, 2028 
Exclusivity Code: ODE - Orphan drug exclusivityDec 18, 2030ODE-460: Treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older

KALYDECO (TABLET) (ORAL) IVACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR) potentiat
NDA Applicant: VERTEX PHARMS      NDA No.:
203188  Prod. No.: 001 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 8629162 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 22, 2018
Jun 24, 2025U-2234: Use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate CF phenotype with at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data
Pat. No. 8354427 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 26, 2015
Jul 6, 2026U-1311: Method of treating cystic fibrosis
U-1905: Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Composition; Compound
Pat. Sub. Date(s): 001: Dec 1, 2013
Dec 28, 2026 
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 17, 2014
Dec 28, 2026 
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Method of use; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 5, 2017
Dec 28, 2026U-1311: Method of treating cystic fibrosis
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: None
May 20, 2027 
Pat. No. 8324242 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 3, 2013
Aug 5, 2027U-1311: Method of treating cystic fibrosis
U-1906: Method of treating a patient having cystic fibrosis, such as a patient having a G551D mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 1, 2020
Aug 13, 2029 
Pat. No. 11564916 Pharmaceutical composition and administrations thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 28, 2023
Aug 13, 2029U-3530: Treatment of CF in a patient age 6 years and older who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJul 31, 2024ODE-189: Treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in the CFTR gene: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, and 3849+10KBC-T
Exclusivity Code: ODE - Orphan drug exclusivityMay 17, 2024ODE-190: Tx of CF in pts 2 yrs and older who have one of the following mutations in the CFTR gene: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
Exclusivity Code: ODE - Orphan drug exclusivityAug 15, 2025ODE-199: The treatment of cystic fibrosis (CF) in patients age 12 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2027ODE-338: For the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one of the additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that have been identified as responsive to ivacaftor potentiation based on in vitro data and identified in the approval on December 21, 2020

KALYDECO (GRANULE) (ORAL) IVACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR) potentiat
NDA Applicant: VERTEX PHARMS INC      NDA No.:
207925  Prod. No.: 001 RX (50MG/PACKET); 002 RX (75MG/PACKET)
PatentsExpirationPatented Use
Pat. No. 8629162 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 22, 2018
Jun 24, 2025U-2234: Use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate CF phenotype with at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data
U-2529: Treatment of a moderate mild clinical phenotype of cf using ivacaftor in a patient age 6 months to <6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data
Pat. No. 8354427 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 14, 2015
Jul 6, 2026U-1311: Method of treating cystic fibrosis
U-1905: Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide
U-2528: Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has a r117h mutation in the CFTR gene
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Composition; Compound
Pat. Sub. Date(s): All strengths: Apr 14, 2015
Dec 28, 2026 
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 14, 2015
Dec 28, 2026 
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Method of use; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Jul 5, 2017
Dec 28, 2026U-1311: Method of treating cystic fibrosis
U-2530: Treatment of CF in a patient age 6 months to < 6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Apr 14, 2015
May 20, 2027 
Pat. No. 8324242 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 14, 2015
Aug 5, 2027U-1311: Method of treating cystic fibrosis
U-1906: Method of treating a patient having cystic fibrosis, such as a patient having a G551D mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide
U-2527: Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 9, 2020
Aug 13, 2029 
Pat. No. 11564916 Pharmaceutical composition and administrations thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 28, 2023
Aug 13, 2029U-3528: Treatment of CF in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916
Pat. No. 8883206 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 14, 2015
Feb 27, 2033 
Pat. No. 10272046 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 29, 2019
Feb 27, 2033U-2531: Treatment of CF in a patient age 6 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 10272046
Pat. No. 11147770 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 14, 2022
Feb 27, 2033U-3339: Treatment of cf in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11147770
Pat. No. 11752106 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 11, 2023
Feb 27, 2033U-3697: Treatment of CF in a patient age 1 month to <6 years who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11752106
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJul 31, 2024ODE-189: Treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in the CFTR gene: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, and 3849+10KBC-T
Exclusivity Code: ODE - Orphan drug exclusivityMay 17, 2024ODE-190: Tx of CF in pts 2 yrs and older who have one of the following mutations in the CFTR gene: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
Exclusivity Code: ODE - Orphan drug exclusivityAug 15, 2025ODE-199: The treatment of cystic fibrosis (CF) in patients age 12 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data
Exclusivity Code: ODE - Orphan drug exclusivityApr 29, 2026ODE-236: Treatment of cystic fibrosis (CF) in patients age 6 months to less than 12 months who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2027ODE-338: For the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one of the additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that have been identified as responsive to ivacaftor potentiation based on in vitro data and identified in the approval on December 21, 2020
Exclusivity Code: ODE - Orphan drug exclusivityMay 3, 2030ODE-435: The treatment of cystic fibrosis (CF) in patients 1 month to less than 4 months of age who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data

KALYDECO (GRANULE) (ORAL) IVACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR) potentiat
NDA Applicant: VERTEX PHARMS INC      NDA No.:
207925  Prod. No.: 003 RX (25MG/PACKET)
PatentsExpirationPatented Use
Pat. No. 8629162 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 003: May 29, 2019
Jun 24, 2025U-2234: Use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate CF phenotype with at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data
U-2965: Treatment of a moderate to mild clinical phenotype of CF using ivacaftor in a patient age 4 months to <6 years who has one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data
Pat. No. 8354427 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 003: May 29, 2019
Jul 6, 2026U-1311: Method of treating cystic fibrosis
U-1905: Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide
U-2964: Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has a R117H mutation in the CFTR gene
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Composition; Compound
Pat. Sub. Date(s): 003: May 29, 2019
Dec 28, 2026 
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Formulation
Pat. Sub. Date(s): 003: May 29, 2019
Dec 28, 2026 
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Method of use; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): 003: May 29, 2019
Dec 28, 2026U-1311: Method of treating cystic fibrosis
U-2966: Treatment of CF in a patient age 4 months to <6 years who has one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: May 29, 2019
May 20, 2027 
Pat. No. 8324242 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 003: May 29, 2019
Aug 5, 2027U-1311: Method of treating cystic fibrosis
U-1906: Method of treating a patient having cystic fibrosis, such as a patient having a G551D mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide
U-2963: Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): 003: Jun 9, 2020
Aug 13, 2029 
Pat. No. 11564916 Pharmaceutical composition and administrations thereof
Claim Types: Method of use
Pat. Sub. Date(s): 003: Feb 28, 2023
Aug 13, 2029U-3528: Treatment of CF in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916
Pat. No. 8883206 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): 003: May 29, 2019
Feb 27, 2033 
Pat. No. 10272046 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: May 29, 2019
Feb 27, 2033U-2967: Treatment of CF in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 10272046
Pat. No. 11147770 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Apr 14, 2022
Feb 27, 2033U-3339: Treatment of cf in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11147770
Pat. No. 11752106 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 11, 2023
Feb 27, 2033U-3697: Treatment of CF in a patient age 1 month to <6 years who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11752106
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJul 31, 2024ODE-189: Treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in the CFTR gene: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, and 3849+10KBC-T
Exclusivity Code: ODE - Orphan drug exclusivityMay 17, 2024ODE-190: Tx of CF in pts 2 yrs and older who have one of the following mutations in the CFTR gene: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
Exclusivity Code: ODE - Orphan drug exclusivityAug 15, 2025ODE-199: The treatment of cystic fibrosis (CF) in patients age 12 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data
Exclusivity Code: ODE - Orphan drug exclusivityApr 29, 2026ODE-236: Treatment of cystic fibrosis (CF) in patients age 6 months to less than 12 months who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2027ODE-338: For the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one of the additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that have been identified as responsive to ivacaftor potentiation based on in vitro data and identified in the approval on December 21, 2020
Exclusivity Code: ODE - Orphan drug exclusivityMay 3, 2030ODE-435: The treatment of cystic fibrosis (CF) in patients 1 month to less than 4 months of age who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data

KALYDECO (GRANULE) (ORAL) IVACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR) potentiat
NDA Applicant: VERTEX PHARMS INC      NDA No.:
207925  Prod. No.: 004 RX (5.8MG/PACKET); 005 RX (13.4MG/PACKET)
PatentsExpirationPatented Use
Pat. No. 8629162 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 30, 2023
Jun 24, 2025U-3607: Treatment of a moderate to mild clinical phenotype of CF using ivacaftor in a patient age 1 month to <4 months who has at least one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data
Pat. No. 8354427 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 30, 2023
Jul 6, 2026U-3608: Treatment of cystic fibrosis using ivacaftor in a patient age 1 month to <4 months who has a R117H mutation in the CFTR gene
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Composition; Compound
Pat. Sub. Date(s): All strengths: May 30, 2023
Dec 28, 2026 
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 30, 2023
Dec 28, 2026 
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Method of use; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: May 30, 2023
Dec 28, 2026U-3606: Treatment of CF in a patient age 1 month to <4 months who has at least one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: May 30, 2023
May 20, 2027 
Pat. No. 8324242 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 30, 2023
Aug 5, 2027U-3609: Treatment of cystic fibrosis using ivacaftor in a patient age 1 month to <4 months who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 30, 2023
Aug 13, 2029 
Pat. No. 11564916 Pharmaceutical composition and administrations thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 30, 2023
Aug 13, 2029U-3603: Treatment of CF in a patient age 1 month to <4 months who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11564916
Pat. No. 8883206 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 30, 2023
Feb 27, 2033 
Pat. No. 10272046 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 30, 2023
Feb 27, 2033U-3605: Treatment of CF in a patient age 1 month to <4 months who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 10272046
Pat. No. 11147770 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 30, 2023
Feb 27, 2033U-3604: Treatment of CF in a patient age 1 month to <4 months who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11147770
Pat. No. 11752106 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 11, 2023
Feb 27, 2033U-3697: Treatment of CF in a patient age 1 month to <6 years who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11752106
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 3, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityMay 3, 2030ODE-435: The treatment of cystic fibrosis (CF) in patients 1 month to less than 4 months of age who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data

SOLODYN (TABLET, EXTENDED RELEASE) (ORAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: BAUSCH      NDA No.:
050808  Prod. No.: 001 DISC (EQ 45MG BASE**); 003 DISC (EQ 135MG BASE**)
PatentsExpirationPatented Use
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 28, 2012; 003: None
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 9, 2012; 003: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 7, 2027U-1078: Treatment of acne

SOLODYN (TABLET, EXTENDED RELEASE) (ORAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: BAUSCH      NDA No.:
050808  Prod. No.: 002 DISC (EQ 90MG BASE**)
PatentsExpirationPatented Use
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Mar 7, 2027U-1078: Treatment of acne
Pat. No. 7541347 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of administration
Pat. Sub. Date(s): 002: None
Apr 2, 2027U-917: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Pat. No. 7544373 DP* Minocycline oral dosage forms for the treatment of acne
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 002: None
Apr 2, 2027 

SOLODYN (TABLET, EXTENDED RELEASE) (ORAL) MINOCYCLINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: tetracycline class drug
NDA Applicant: BAUSCH      NDA No.:
050808  Prod. No.: 004 RX (EQ 65MG BASE); 005 RX (EQ 115MG BASE)
PatentsExpirationPatented Use
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 7, 2027U-1078: Treatment of acne
Pat. No. 9192615 DP* Method for the treatment of acne and certain dosage forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 8, 2016
Nov 17, 2031 

SOLODYN (TABLET, EXTENDED RELEASE) (ORAL) MINOCYCLINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: tetracycline class drug
NDA Applicant: BAUSCH      NDA No.:
050808  Prod. No.: 006 RX (EQ 105MG BASE); 007 RX (EQ 80MG BASE); 008 RX (EQ 55MG BASE)
PatentsExpirationPatented Use
Pat. No. 7790705 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8252776 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-124: Treatment of acne
Pat. No. 8268804 Minocycline oral dosage forms for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 8722650 Extended-release minocycline dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 24, 2025U-1078: Treatment of acne
Pat. No. 7919483 Method for the treatment of acne
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 7, 2027U-1078: Treatment of acne

SYMDEKO (COPACKAGED) (TABLET) (ORAL) IVACAFTOR; IVACAFTOR, TEZACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR) potentiat
NDA Applicant: VERTEX PHARMS INC      NDA No.:
210491  Prod. No.: 001 RX (150MG;150MG, 100MG); 002 RX (75MG;75MG, 50MG)
PatentsExpirationPatented Use
Pat. No. 8629162 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Jun 24, 2025U-2247: Tezacaftor and ivacaftor for the treatment of patients with a mild to moderate clinical phenotype of cystic fibrosis having at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
Pat. No. 8354427 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 14, 2021
Jul 6, 2026U-3021: Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients age 6 years and older who have a R117H mutation in the CFTR gene
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Composition; Compound
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Dec 28, 2026 
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Dec 28, 2026 
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Method of use; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Dec 28, 2026U-2246: Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the F508del mutation or having at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: May 1, 2018; 002: Jul 17, 2019
Dec 28, 2026U-2275: Treating cystic fibrosis patients ages 12 and older, who are homozygous for F508del or have at least 1 CFTR gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor
U-2575: Treating cystic fibrosis patients ages 6 and older, who are homozygous for F508DEL or have at least 1 CFTR gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor
Pat. No. 9974781 DP* Modulators of ATP-binding cassette transporters
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Jun 20, 2018; 002: Jul 17, 2019
Apr 9, 2027U-2318: Treatment of cystic fibrosis in patients aged 12 and older, who are homozygous for the F508del mutation or have at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor
U-2574: Treatment of cystic fibrosis in patients aged 6 and older, who are homozygous for the F508DEL mutation or have at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor
Pat. No. 10022352 DP* Modulators of ATP-binding cassette transporters
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Aug 8, 2018; 002: Jul 17, 2019
Apr 9, 2027U-2343: Treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the F508del mutation or heterozygous for F508del and a second CFTR mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor
U-2573: Treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the F508DEL mutation or heterozygous for F508DEL and a second CFTR mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor
Pat. No. 10239867 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Apr 19, 2019; 002: Jul 17, 2019
Apr 9, 2027U-2512: Treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the F508DEL mutation or have at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor
U-2569: Treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the F508DEL mutation or have at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor
Pat. No. 11639347 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 22, 2023
Apr 9, 2027U-2569: Treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the F508DEL mutation or have at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor
Pat. No. 7645789 DS* DP* Indole derivatives as CFTR modulatorsClaim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
May 1, 2027 
Pat. No. 8598181 Modulators of ATP-binding cassette transpor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
May 1, 2027U-2246: Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the F508del mutation or having at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
Pat. No. 8623905 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition; Formulation; Kit
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
May 1, 2027 
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
May 20, 2027 
Pat. No. 7776905 DS* DP* Modulators of ATP-binding cassette transport
Claim Types: Compound; Composition; Kit
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Jun 3, 2027 
Pat. No. 8324242 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Aug 5, 2027U-2246: Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the F508del mutation or having at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
Pat. No. 8415387 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Nov 12, 2027U-2246: Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the F508del mutation or having at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 8, 2020
Aug 13, 2029 
Pat. No. 11564916 Pharmaceutical composition and administrations thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 28, 2023
Aug 13, 2029U-3527: Treatment of CF in a patient age 6 years and older who is homozygous for F508DEL or has at least one CFTR gene mutation responsive to TEZ/IVA based on in vitro data and/or clinical evidence using the composition recited in US 11564916 claim 1
Pat. No. 10081621 DP* Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018; 002: Jul 17, 2019
Mar 25, 2031U-2420: Treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the F508DEL mutation or one F508DEL mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,081,621
U-2571: Treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the F508DEL mutation or one F508DEL mutation and a CFTR mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,081,621
U-3024: Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the F508DEL mutation or who have at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,081,621
U-3025: Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the F508DEL mutation or who have at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,081,621
Pat. No. 11578062 DP* Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 16, 2023
Mar 25, 2031U-3545: Treatment of cf in a patient age 6 years and older who is homozygous for F508DEL or has at least one CFTR gene mutation responsive to tez/iva based on in vitro data and/or clinical evidence using the composition recited in us 11578062 claim 6 or 13
Pat. No. 9012496 Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 9, 2018; 002: Jul 17, 2019
Jul 15, 2033U-2248: Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the F508del mutation or heterozygous for the F508del mutation and a second mutation that is responsive to tezacaftor/ivacaftor
Pat. No. 10058546 Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 21, 2018; 002: Jul 17, 2019
Jul 15, 2033U-2399: Treatment of cystic fibrosis in patients 12 years and older, with a F508DEL or G551D CFTR gene mutation and a A455E, 2789+5G->A, or 3849+10KBC->T mutation, comprising concurrent coadministration of the compositions of claim 1 of U.S patent 10058546
U-2572: Treatment of cystic fibrosis in patients 6 years and older, with a F508DEL or g551d CFTR gene mutation and a a455e, 2789+5g->, or 3849+10kbc->t mutation, comprising concurrent coadministration of the compositions of claim 1 of U.S. patent 10058546
U-3022: Treatment of CF in patients 12 years and older who have a F508DEL or G551D CFTR mutation and a 2nd mutation selected from R117H, A455E, 2789+5G->A, & 3849+10KBC->T, comprising concurrent coadministration of the compositions of claim 1 of US 10058546
U-3023: Treatment of cf in patients 6 years and older who have a F508DEL OR G551D CFTR mutation and a 2nd mutation selected from R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, comprising concurrent coadministration of the compositions of claim 1 of US 10058546
Pat. No. 10206877 DP* Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 20, 2019; 002: Jul 17, 2019
Apr 14, 2035U-2498: Treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the F508DEL mutation or one F508DEL mutation and a CFTR mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,206,877
U-2570: Treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the F508DEL mutation or one F508DEL mutation and a CFTR mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,206,877
U-3026: Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the F508DEL mutation or at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,206,877
U-3027: Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the F508DEL mutation or at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,206,877
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityFeb 12, 2025ODE-173: Treatment of patients with cystic fibrosis aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene responsive to tezacaftor/ivacaftor
Exclusivity Code: ODE - Orphan drug exclusivityJun 21, 2026ODE-247: Tx of pts w/ cystic fibrosis (CF) age 6 to <12 yrs who are homozygous for the F508DEL mutation or w/ at least 1 mutation in CF transmembrane conductance regulatory gene responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2027ODE-335: For treatment of cystic fibrosis (CF) in patients age 6 years and older who have at least one of the additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that have been identified as responsive to tezacaftor/ivacaftor based on in vitro data and identified in the approval on December 21, 2020

TRIKAFTA (COPACKAGED) (TABLET) (ORAL) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR) potentiat
NDA Applicant: VERTEX PHARMS INC      NDA No.:
212273  Prod. No.: 001 RX (100MG,75MG,50MG; 150MG)
PatentsExpirationPatented Use
Pat. No. 8629162 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
Jun 24, 2025U-2648: Treatment of a moderate to mild clinical phenotype of CF in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3030: Treatment of a moderate to mild clinical phenotype of CF in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elx, tez, and iva
U-3146: Treatment of a moderate to mild clinical phenotype of CF in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elx, tez, and iva
Pat. No. 8354427 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
Jul 6, 2026U-2646: Treatment of cystic fibrosis in patients aged 12 years and older who have one f508del mutation and one r117h mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3029: Treatment of cystic fibrosis in patients aged 12 years and older who have a R117H mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3145: Treatment of cystic fibrosis in patients aged 6 years and older who have a R117H mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Composition; Compound
Pat. Sub. Date(s): 001: Nov 14, 2019
Dec 28, 2026 
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 14, 2019
Dec 28, 2026 
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Claim Types: Method of use; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Nov 14, 2019
Dec 28, 2026U-2650: Treatment of CF in patients aged 12 years and older who have at least one F508DEL mutation in the cftr gene using a solid composition comprising elexacaftor, tezacaftor, amorphous ivacaftor, and less than about 30% crystalline ivacaftor
U-3031: Treatment of CF in patients 12 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva
U-3155: Treatment of CF in patients 6 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva
Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Nov 14, 2019
Dec 28, 2026U-2650: Treatment of CF in patients aged 12 years and older who have at least one F508DEL mutation in the cftr gene using a solid composition comprising elexacaftor, tezacaftor, amorphous ivacaftor, and less than about 30% crystalline ivacaftor
U-3031: Treatment of CF in patients 12 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva
U-3155: Treatment of CF in patients 6 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva
Pat. No. 9974781 DP* Modulators of ATP-binding cassette transporters
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Nov 14, 2019
Apr 9, 2027U-2645: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
Pat. No. 10022352 DP* Modulators of ATP-binding cassette transporters
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Nov 14, 2019
Apr 9, 2027U-2651: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor
U-3156: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor
Pat. No. 10239867 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
Apr 9, 2027U-2653: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with an effective amount of elexacaftor, tezacaftor, and ivacaftor
U-3033: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva
U-3158: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva
Pat. No. 11639347 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 24, 2023
Apr 9, 2027U-3587: Treatment of cystic fibrosis in patients aged 6 years and older who have in the CFTR gene at least one F508DEL mutation or a responsive mutation based on in vitro data with an effective amount of elx, tez, and iva
Pat. No. 7645789 DS* DP* Indole derivatives as CFTR modulatorsClaim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Nov 14, 2019
May 1, 2027 
Pat. No. 8598181 Modulators of ATP-binding cassette transpor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
May 1, 2027U-2645: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
Pat. No. 8623905 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition; Formulation; Kit
Pat. Sub. Date(s): 001: Nov 14, 2019
May 1, 2027 
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Nov 14, 2019
May 20, 2027 
Pat. No. 7776905 DS* DP* Modulators of ATP-binding cassette transport
Claim Types: Compound; Composition; Kit
Pat. Sub. Date(s): 001: Nov 14, 2019
Jun 3, 2027 
Pat. No. 8324242 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
Aug 5, 2027U-2645: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
Pat. No. 8415387 Modulators of ATP-binding cassette transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
Nov 12, 2027U-2645: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 8, 2020
Aug 13, 2029 
Pat. No. 11564916 Pharmaceutical composition and administrations thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 28, 2023
Aug 13, 2029U-3525: Treatment of cf in patients aged 6 years and older who have in the cftr gene at least one F508DEL mutation or a mutation that is responsive based on in vitro data by administering the composition recited in US 11564916 claim 1
Pat. No. 10081621 DP* Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
Mar 25, 2031U-2652: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with a composition according to claim 1 of us 10081621
U-3032: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with a composition according to claim 1 of US 10081621
U-3157: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with a composition according to claim 1 of US 10081621
Pat. No. 11578062 DP* Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 15, 2023
Mar 25, 2031U-3544: Treatment of cf in patients aged 6 years and older who have in the cftr gene at least one F508DEL mutation or a responsive mutation based on in vitro data by administering elexacaftor, ivacaftor, and a solid dispersion of tezacaftor and a polymer
Pat. No. 9012496 Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 14, 2019
Jul 15, 2033U-2649: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; and another composition comprising ivacaftor
U-3154: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; and another composition comprising ivacaftor
Pat. No. 10758534 DS* DP* Modulators of cystic fibrosis transmembrane conductance regulator
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 22, 2020
Oct 6, 2035U-2645: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
Pat. No. 11426407 DS* DP* Modulators of cystic fibrosis transmembrane conductance regulator
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 26, 2022
Oct 6, 2035U-3425: Treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one F508DEL mutation or a mutation that is responsive based on in vitro data with a compound of claim 1 or composition of claim 29 of US11426407
Pat. No. 10793547 DS* DP* Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Oct 29, 2020
Dec 8, 2037U-2645: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor
U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor
Pat. No. 11179367 DP* Pharmaceutical compositions for treating cystic fibrosis
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Dec 14, 2021
Dec 8, 2037U-3253: Treatment of cystic fibrosis in patients aged 6 years and older who have in the CFTR gene at least one F508DEL mutation or a mutation that is responsive based on in vitro data with a composition according to at least one of claims 1-9 of US11179367
Pat. No. 11453655 DS* DP* Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Oct 21, 2022
Dec 8, 2037 
Pat. No. 11517564 DP* Methods of treatment for cystic fibrosis
Claim Types: Method of use; Composition; Formulation
Pat. Sub. Date(s): 001: Jan 5, 2023
Dec 8, 2037U-3498: Treatment of cystic fibrosis in patients aged 6 years and older who have in the CFTR gene at least one F508DEL mutation or a mutation that is responsive based on in vitro data by administering daily ELX (200 mg or 100 mg); TEZ; and IVA
Exclusivity