Tradenames starting with "A"

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.


ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.:
021436  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 7, 2015
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder

ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)
PatentsExpirationPatented Use
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 22, 2014
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
PatentsExpirationPatented Use
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 7, 2015
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
PatentsExpirationPatented Use
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Dec 16, 2024 *PED 

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 

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

ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.:
202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
PatentsExpirationPatented Use
Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014
Oct 19, 2024 
Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 19, 2024U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8338427 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: None
Mar 15, 2025U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
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): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014
Jun 29, 2025 
Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014
Oct 19, 2024 
Pat. No. 10525057 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jan 31, 2020
Mar 8, 2034U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-2723: Maintenance monotherapy treatment of Bipolar 1 disorder
U-543: Treatment of schizophrenia
Pat. No. 10980803 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 19, 2021
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 11154553 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 17, 2021
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11344547 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2022
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11400087 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 29, 2022
Sep 24, 2033U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
U-3245: Maintenance monotherapy treatment of bipolar I disorder
U-814: Treatment of schizophrenia
Pat. No. 11648347 DP* Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jun 15, 2023
Apr 6, 2034 

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.:
207202  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 7978064 DP* Communication system with partial power source
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 14, 2026 
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Composition; Product-by-process; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 16, 2024 
Pat. No. 8114021 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 21, 2030 
Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 25, 2030 
Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Apr 27, 2030 
Pat. No. 8547248 DP* Implantable zero-wire communications system
Claim Types: Device; Method of use; Kit
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 18, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8674825 DP* Pharma-informatics system
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Apr 9, 2029U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 8718193 DP* Active signal processing personal health signal receivers
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 5, 2029 
Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 2, 2027U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 8847766 DP* Pharma-informatics system
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 29, 2030U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8945005 DP* Controlled activation ingestible identifier
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Aug 19, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8956288 DP* In-body power source having high surface area electrode
Claim Types: Device; Method-of-use; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jul 6, 2029U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver
Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 17, 2030 
Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 5, 2029 
Pat. No. 9119554 DP* Pharma-informatics system
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 16, 2028 
Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jul 28, 2026U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
Pat. No. 9149577 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2029 
Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Mar 5, 2029 
Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Oct 15, 2033U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver
Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2031 
Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 15, 2029 
Pat. No. 9444503 DP* Active signal processing personal health signal receivers
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Nov 19, 2027U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient
Pat. No. 9941931 DP* System for supply chain management
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 7, 2018
Nov 4, 2030 
Pat. No. 10441194 DP* Ingestible event marker systems
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 1, 2019
Jul 26, 2029 
Pat. No. 10517507 DP* Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 23, 2020
Jun 13, 2032 
Pat. No. 11229378 DP* Communication system with enhanced partial power source and method of manufacturing same
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Feb 18, 2022
Jul 11, 2031 
Pat. No. 11464423 DP* In-body power source having high surface area electrode
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 9, 2022
Sep 15, 2030 
Pat. No. 11476952 DP* Pharma-informatics system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 9, 2022
Apr 28, 2026 

ABLYSINOL (SOLUTION) (INTRA-ARTERIAL) ALCOHOL
Drug Classes: pediculicide
NDA Applicant: BPI LABS      NDA No.:
207987  Prod. No.: 001 RX (99% (1ML)); 002 RX (99% (5ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 21, 2025ODE-192: Indicated to induce controlled cardiac septal infraction [sic, "infarction"] to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy

ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: BRISTOL-MYERS      NDA No.:
021660  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2010
Apr 27, 2025 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2011
Jun 9, 2024 *PEDU-1117: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Feb 13, 2027 *PEDU-1290: Treatment of lung cancer
Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2012
Jun 9, 2024 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Aug 21, 2026 *PEDU-1290: Treatment of lung cancer
Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2012
Jun 9, 2024 *PEDU-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2015
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 9393318 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2016
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9511046 Methods of treating pancreatic cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2016
Jul 12, 2034 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 9597409 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2017
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer

ABSORICA LD (CAPSULE) (ORAL) ISOTRETINOIN [Has competitive generic]
Drug Classes: retinoid
NDA Applicant: SUN PHARM      NDA No.:
211913  Prod. No.: 001 RX (8MG); 002 RX (16MG); 004 RX (24MG); 006 RX (32MG) NDA No.: 211913  Prod. No.: 003 DISC (20MG); 005 DISC (28MG)
PatentsExpirationPatented Use
Pat. No. 9700535 DP* Oral pharmaceutical composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2019
Aug 4, 2035 
Pat. No. 9750711 DP* Low dose oral pharmaceutical composition of isotretinoin
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2019
May 29, 2035 

ACANYA (GEL) (TOPICAL) BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE [GENERIC AB]
Drug Classes: lincosamide antibacterial
NDA Applicant: BAUSCH      NDA No.:
050819  Prod. No.: 001 RX (2.5%;EQ 1.2% BASE)
PatentsExpirationPatented Use
Pat. No. 8288434 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 19, 2012
Aug 5, 2029U-124: Treatment of acne
Pat. No. 8663699 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 6, 2014
Jun 3, 2029U-124: Treatment of acne
Pat. No. 8895070 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2015
Jun 3, 2029U-124: Treatment of acne
Pat. No. 9078870 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 13, 2015
Jun 3, 2029 
Pat. No. 10220049 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 8, 2019
Jun 3, 2029U-916: Topical treatment of acne vulgaris in patients 12 years or older
Pat. No. 10624918 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 11, 2020
Jun 3, 2029U-916: Topical treatment of acne vulgaris in patients 12 years or older

ACCRUFER (CAPSULE) (ORAL) FERRIC MALTOL
NDA Applicant: SHIELD TX      NDA No.:
212320  Prod. No.: 001 RX (30MG IRON)
PatentsExpirationPatented Use
Pat. No. 9248148 Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2019
Mar 29, 2031U-2603: Method of treating iron deficiency
Pat. No. 9802973 DS* DP* Crystalline forms of ferric maltol
Claim Types: New polymorph, salt or hydrate; Process; Composition; Product-by-process; Method of use
Pat. Sub. Date(s): 001: Aug 22, 2019
Oct 23, 2035U-2603: Method of treating iron deficiency
Pat. No. 10179120 Dosage regimen of ferric trimaltol
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2019
Jan 6, 2035U-2603: Method of treating iron deficiency
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 25, 2024 

ACETADOTE (INJECTABLE) (INTRAVENOUS) ACETYLCYSTEINE [GENERIC AP]
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: CUMBERLAND PHARMS      NDA No.:
021539  Prod. No.: 001 RX (6GM/30ML (200MG/ML))
PatentsExpirationPatented Use
Pat. No. 8148356 DP* Acetylcysteine composition and uses therefor
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Apr 4, 2012
May 21, 2026 
Pat. No. 8399445 Acetylcysteine composition and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2013
Aug 24, 2025U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8653061 Acetylcysteine composition and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 24, 2014
Aug 24, 2025U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 8722738 Acetycysteine compositions and methods of use thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 27, 2014
Apr 6, 2032U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions
Pat. No. 9327028 Acetylcysteine compositions and methods of use thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 18, 2016
Jul 21, 2031U-1839: Composition and method for providing a reduction in side effects for human patients in need of acetylcysteine therapy

ACETAMINOPHEN (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN [Has competitive generic]
NDA Applicant: FRESENIUS KABI USA      NDA No.:
204767  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 8741959 DP* Paracetamol for parenteral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 24, 2019
Apr 19, 2030 

ACTHAR GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: MALLINCKRODT ARD      NDA No.:
008372  Prod. No.: 008 RX (80 UNITS/ML)
PatentsExpirationPatented Use
Pat. No. 11752199 Methods of modulating pericytes
Claim Types: Method of use
Pat. Sub. Date(s): 008: Sep 21, 2023
Feb 25, 2041U-3686: Treatment of exacerbations of multiple sclerosis in adults with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering
U-3687: Treatment of infantile spasms with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering
U-3688: Treatment of ophthalmic diseases with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering

ACTOPLUS MET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: biguanide == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
021842  Prod. No.: 002 RX (850MG;EQ 15MG BASE) NDA No.: 021842  Prod. No.: 001 DISC (500MG;EQ 15MG BASE**)
PatentsExpirationPatented Use
Pat. No. 9101660 DP* Solid preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 10, 2015
Jan 22, 2027 
Pat. No. 9320714 DP* Tablet
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 20, 2016
Feb 3, 2029 

ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: biguanide == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
022024  Prod. No.: 001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
PatentsExpirationPatented Use
Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jul 31, 2026 
Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None
Jul 31, 2026 

ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE      NDA No.:
021528  Prod. No.: 001 RX (0.4%)
PatentsExpirationPatented Use
Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 23, 2011
Nov 24, 2027 *PEDU-1181: A method of treating or preventing ocular pain in a patient
Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2012
Nov 28, 2024 *PEDU-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient
Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 18, 2013
Nov 28, 2024 *PEDU-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery
Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013
Nov 28, 2024 *PEDU-1441: A method of treating or reducing ocular pain and burning/stinging
Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 4, 2014
May 28, 2024 
Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2015
May 28, 2024U-1626: A method of treating or preventing ocular pain and burning
Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 4, 2015
May 28, 2024U-1662: A method of treating ocular pain
Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016
May 28, 2024U-1800: A method of treating ocular pain and/or enhancing ocular comfort

ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE      NDA No.:
022427  Prod. No.: 001 RX (0.45%)
PatentsExpirationPatented Use
Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 30, 2010
Aug 15, 2029 
Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 19, 2013
Mar 7, 2028 
Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 10, 2015
Aug 5, 2024 
Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015
Mar 7, 2028 

ACUVUE THERAVISION WITH KETOTIFEN (DRUG-ELUTING CONTACT LENS) (OPHTHALMIC) KETOTIFEN FUMARATE
Drug Classes: histamine-1 (H1) receptor inhibitor
NDA Applicant: JOHNSON JOHNSON VISN      NDA No.:
022388  Prod. No.: 001 DISC (EQ 19MCG BASE)
PatentsExpirationPatented Use
Pat. No. 9474746 DP* Methods for stabilizing oxidatively unstable compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 23, 2022
Mar 27, 2028 
Pat. No. 9962376 DP* Methods and ophthalmic devices used in the treatment of ocular allergies
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 23, 2022
Jun 27, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 25, 2025 

ACYCLOVIR (CREAM) (TOPICAL) ACYCLOVIR [GENERIC AB]
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibi
NDA Applicant: ALEMBIC      NDA No.:
212361  Prod. No.: 001 RX (5%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJun 12, 2024 

ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: sulfone
NDA Applicant: ALMIRALL      NDA No.:
207154  Prod. No.: 001 RX (7.5%)
PatentsExpirationPatented Use
Pat. No. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 1, 2016
Nov 18, 2033 
Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 16, 2016
Nov 18, 2033U-1033: Topical treatment of acne vulgaris
Pat. No. 11273132 DP* Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2022
Nov 18, 2033 

ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS      NDA No.:
022549  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Aug 18, 2024 
Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 28, 2024 
Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 23, 2026 
Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Apr 29, 2015
May 21, 2024 
Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 7, 2016
May 20, 2024 

ADDYI (TABLET) (ORAL) FLIBANSERIN
NDA Applicant: SPROUT PHARMS      NDA No.:
022526  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7151103 [Extended 5 years]
Method of treating female hypoactive sexual desire disorder with flibanserin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2015
May 9, 2028U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)

ADEMPAS (TABLET) (ORAL) RIOCIGUAT [GENERIC AB]
Drug Classes: soluble guanylate cyclase (sGC) stimulator
NDA Applicant: BAYER HLTHCARE      NDA No.:
204819  Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (1.5MG); 004 RX (2MG); 005 RX (2.5MG)
PatentsExpirationPatented Use
Pat. No. 7173037 DS* DP* [Extended 1319 days (3.6 years)]
Carbamate-substituted pyrazolopyridines
Claim Types: Compound; Process; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 6, 2013
Dec 4, 2026 
Pat. No. 10662188 DS* DP* Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Jun 23, 2020
Feb 18, 2034U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class
U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening
Pat. No. 11203593 DS* DP* Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimid- ino-5-yl}methyl carbamate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jan 14, 2022
Feb 18, 2034U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class
U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening

ADHANSIA XR (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [Has competitive generic]
Drug Classes: central nervous system stimulant
NDA Applicant: PURDUE PHARMA LP      NDA No.:
212038  Prod. No.: 001 DISC (25MG); 002 DISC (35MG); 003 DISC (45MG); 004 DISC (55MG); 005 DISC (70MG); 006 DISC (85MG)
PatentsExpirationPatented Use
Pat. No. 9974752 DP* Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 8, 2019
Oct 30, 2035 
Pat. No. 10111839 Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10292938 DP* Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 22, 2019
Oct 30, 2035 
Pat. No. 10292939 DP* Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: May 22, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10449159 Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 22, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10500162 Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 11, 2019
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10507186 DP* Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 18, 2019
Oct 30, 2035 
Pat. No. 10512612 DP* Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 2, 2020
Oct 30, 2035 
Pat. No. 10512613 Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 2, 2020
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10568841 DP* Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Feb 26, 2020
Oct 30, 2035U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
Pat. No. 10688060 DP* Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 23, 2020
Oct 30, 2035 
Pat. No. 10722473 Methods and compositions particularly for treatment of attention deficit disorder
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 28, 2020
Nov 19, 2038U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 28, 2024M-82: Labeling revisions related to clinical studies

ADLARITY (SYSTEM) (TRANSDERMAL) DONEPEZIL HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor
NDA Applicant: CORIUM      NDA No.:
212304  Prod. No.: 001 RX (5MG/DAY); 002 RX (10MG/DAY)
PatentsExpirationPatented Use
Pat. No. 9993466 DP* Donepezil transdermal delivery system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10016372 Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10300025 DP* Donepezil transdermal delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10307379 DP* Donepezil transdermal delivery system
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037 
Pat. No. 10835499 DP* Systems and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
May 20, 2038U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 10966936 DP* Systems comprising a composite backing and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Aug 11, 2038U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 11103463 Methods for treating Alzheimer's disease with donepezil transdermal system
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 6, 2022
Jul 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 11648214 DP* Systems and methods for long term transdermal administration
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 2, 2023
Sep 23, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
Pat. No. 11679086 Systems comprising a composite backing and methods for long term transdermal administration
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 3, 2023
May 26, 2037U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 11, 2025 

ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.:
204200  Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 14, 2016
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis

ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 204640  Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2015
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis
Pat. No. 10130592 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 26, 2018
Mar 13, 2035 

ADRENALIN (SOLUTION) (INTRAVENOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 215875  Prod. No.: 001 RX (2MG/250ML (8MCG/ML)); 002 RX (4MG/250ML (16MCG/ML)); 003 RX (5MG/250ML (20MCG/ML)); 004 RX (8MG/250ML (32MCG/ML)); 005 RX (10MG/250ML (40MCG/ML))
PatentsExpirationPatented Use
Pat. No. 10653646 DP* Epinephrine compositions and containers
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 10, 2023
Mar 21, 2039 
Pat. No. 11083698 Epinephrine compositions and containers
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): All strengths: May 10, 2023
Mar 21, 2039U-3567: To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock
Pat. No. 11207280 DP* Epinephrine compositions and containers
Claim Types: Process; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 10, 2023
Mar 21, 2039 

ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.:
021254  Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7500444 DP* Actuation indicator for a dispensing device
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Aug 26, 2026 *PED 

ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == nonsteroidal anti-inflammatory drug == alpha adrenergic agonist
NDA Applicant: HALEON US HOLDINGS      NDA No.:
021441  Prod. No.: 001 OTC (2MG;200MG;30MG)
PatentsExpirationPatented Use
Pat. No. 7863287 DP* Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 6, 2011
Feb 28, 2027 

ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == nonsteroidal anti-inflammatory drug == alpha adrenergic agonist
NDA Applicant: HALEON US HOLDINGS      NDA No.:
021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 24, 2019
May 25, 2024 

ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HALEON US HOLDINGS      NDA No.:
020589  Prod. No.: 002 OTC (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 002: Apr 24, 2019
May 25, 2024 

ADZENYS ER (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: NEOS THERAPS INC      NDA No.:
204325  Prod. No.: 001 DISC (EQ 1.25MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Jun 28, 2032 

ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: NEOS THERAPS      NDA No.:
204326  Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 26, 2016
Apr 9, 2026 
Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 
Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 28, 2032 

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 

AFINITOR (TABLET) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS      NDA No.:
022334  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (2.5MG); 004 RX (7.5MG)
PatentsExpirationPatented Use
Pat. No. 8410131 Cancer treatment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 2, 2013
May 1, 2026 *PEDU-1368: Treatment of solid excretory system tumors; advanced renal cell carcinoma (RCC), after failure of treatment with sunitinib or sorafenib
Pat. No. 9006224 Neuroendocrine tumor treatment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 20, 2015
Jul 1, 2028U-1681: Treatment of patients with progressive neuroendocrine tumors of pancreatic origin (pnet) that are unresectable, locally advanced or metastatic

AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM      NDA No.:
203985  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 10, 2025ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures

AGAMREE (SUSPENSION) (ORAL) VAMOROLONE
Drug Classes: corticosteroid
NDA Applicant: CATALYST PHARMS      NDA No.:
215239  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 8334279 Non-hormonal steroid modulators of NF-κB for treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 21, 2023
May 28, 2029U-3747: Treatment of Duchenne muscular dystrophy
Pat. No. 10857161 DP* Non-hormonal steroid modulators of NF-kB for treatment of disease
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 21, 2023
May 28, 2029U-3747: Treatment of Duchenne muscular dystrophy
Pat. No. 11382922 DS* DP* Aqueous oral pharmaceutical suspension compositions
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Nov 21, 2023
Jul 16, 2040 
Pat. No. 11471471 Aqueous oral pharmaceutical suspension compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 21, 2023
Mar 17, 2040U-3747: Treatment of Duchenne muscular dystrophy
Pat. No. 11690853 Non-hormonal steroid modulators of NF-κβ for treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 21, 2023
Mar 7, 2033U-3747: Treatment of Duchenne muscular dystrophy
Pat. No. 11833159 DP* Non-hormonal steroid modulators of NF-kB for treatment of disease
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 18, 2023
May 28, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 26, 2028 
Exclusivity Code: ODE - Orphan drug exclusivityOct 26, 2030ODE-450: Treatment of duchenne muscular dystrophy (DMD) in patients 2 years of age and older

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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Sep 26, 2028 *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. 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. 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. 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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Aug 2, 2019
Nov 19, 2025 *PED 
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. 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. 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. 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. 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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2020
Nov 19, 2025 *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. 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. 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 
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. 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. 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 
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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Sep 26, 2028 *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. 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. 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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 19, 2025 *PED 
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. 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. 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. 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. 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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *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. 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. 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 
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. 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. 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 

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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Sep 26, 2028 *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. 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. 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. 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. 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
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. 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. 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. 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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
Nov 19, 2025 *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 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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Sep 26, 2028 *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. 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. 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
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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 19, 2025 *PED 
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. 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. 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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *PED 

AIRSUPRA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE; BUDESONIDE
Drug Classes: beta-2 adrenergic agonist == corticosteroid
NDA Applicant: ASTRAZENECA      NDA No.:
214070  Prod. No.: 001 RX (EQ 0.09MG BASE/INH;0.08MG/INH)
PatentsExpirationPatented Use
Pat. No. 9415009 Compositions, methods and systems for respiratory delivery of two or more active agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 24, 2023
May 28, 2030U-3509: As-needed treatment or prevention of bronchoconstriction and reduction of the risk of exacerbations in patients with asthma 18 years of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 10, 2026 

AKEEGA (TABLET) (ORAL) ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
Drug Classes: CYP17 inhibitor == poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: JANSSEN BIOTECH      NDA No.:
216793  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (500MG;EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Aug 12, 2027U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8071623 DS* DP* [Extended 702 days (1.9 years)]
Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Mar 27, 2031 
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Aug 12, 2027U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 8436185 DS* DP* Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Apr 24, 2029 
Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Aug 4, 2031U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 11091459 DS* DP* Niraparib compositions
Claim Types: Formulation; Process; Composition
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Mar 27, 2038 
Pat. No. 11207311 Method of treating prostate cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Jul 28, 2037U-2830: A method for treating metastatic castration-resistant prostate cancer (MCRPC), wherein the cancer is associated with a deleterious BRCA-mutation
Pat. No. 11673877 DS* DP* Niraparib compositions
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2023
Mar 27, 2038 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 11, 2026 

AKLIEF (CREAM) (TOPICAL) TRIFAROTENE
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.:
211527  Prod. No.: 001 RX (0.005%)
PatentsExpirationPatented Use
Pat. No. 7807708 DS* DP* [Extended 1752 days (4.8 years)]
Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 31, 2019
Jul 19, 2031 
Pat. No. 8227507 Ligands that modulate RAR receptors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 31, 2019
Dec 21, 2025U-818: Topical treatment of acne vulgaris
Pat. No. 8470871 Ligands that modulate RAR receptors
Claim Types: Method of use defined by mechanism of action
Pat. Sub. Date(s): 001: Oct 31, 2019
Dec 21, 2025U-2639: Method of activating rargamma receptor
Pat. No. 9084778 DP* Topical compositions containing a retinoid of the oil-in-water emulsion type
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 31, 2019
May 30, 2033U-134: Treatment of acne vulgaris
Pat. No. 9498465 DP* Topical compositions in the form of a gel containing a particular solubilized retinoid
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2021
May 30, 2033U-1033: Topical treatment of acne vulgaris
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 4, 2024 

AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic == antiarrhythmic
NDA Applicant: THEA PHARMA      NDA No.:
022221  Prod. No.: 001 RX (3.5%)
PatentsExpirationPatented Use
Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 30, 2014
Jul 24, 2026U-1523: Method of inducing topical anesthesia in the eye

AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.:
205718  Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 8623826 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 6, 2014
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 8951969 DP* Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 6, 2015
Nov 18, 2030 
Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 2, 2015
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9271975 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Jul 14, 2016
Sep 9, 2031U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9943515 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 16, 2018
Nov 18, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 9951016 DS* DP* Crystalline forms of an NK-1 antagonist
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 16, 2018
Sep 25, 2035 
Pat. No. 10233154 DS* Crystalline forms of an NK-1 antagonist
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Mar 28, 2019
Sep 25, 2035 
Pat. No. 10676440 DS* DP* Crystalline forms of an NK-1 antagonist
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Jul 8, 2020
Sep 25, 2035 
Pat. No. 10828297 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2020
Dec 17, 2030U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
Pat. No. 10961195 DS* DP* Crystalline forms of an NK-1 antagonist
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 15, 2021
Sep 25, 2035 
Pat. No. 11559523 DP* Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use; Composition
Pat. Sub. Date(s): 001: Feb 22, 2023
Nov 18, 2030U-3522: Method of treating emesis

AKYNZEO (POWDER; SOLUTION) (INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 210493  Prod. No.: 002 RX (EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)) NDA No.: 210493  Prod. No.: 001 DISC (EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 8426450 DS* DP* Substituted 4-phenyl pyridines having anti-emetic effect
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
May 23, 2032 
Pat. No. 8895586 Methods of treating emesis
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
May 23, 2032U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
Nov 18, 2030U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 9403772 DS* 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tol- yl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator
Claim Types: New polymorph, salt or hydrate; Method of use; Process; Compound
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
May 23, 2032U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 9908907 DS* DP* Substituted piperaziniums for the treatment of emesis
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020
May 23, 2032 
Pat. No. 10208073 Solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-to- lyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnet- upitant) and palonosetron hydrochloride in combination with dexamethasone as a neurokinin receptor modulator
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 8, 2019; 002: Jun 24, 2020
May 23, 2032U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 10624911 DP* Physiologically balanced injectable formulations of fosnetupitant
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: May 26, 2020; 002: Jun 24, 2020
Jun 2, 2037 
Pat. No. 10717721 DS* Substituted piperaziniums for the treatment of emesis
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Aug 19, 2020
May 23, 2032 
Pat. No. 10828297 Compositions and methods for treating centrally mediated nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 9, 2020
Dec 17, 2030U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Pat. No. 11312698 DS* DP* Fosnetupitant chloride hydrochloride having improved stability
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: May 13, 2022
May 23, 2032 
Pat. No. 11529362 DP* Physiologically balanced injectable formulations of fosnetupitant
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 17, 2023
Jun 2, 2037 

ALDARA (CREAM) (TOPICAL) IMIQUIMOD [Has competitive generic]
NDA Applicant: BAUSCH      NDA No.:
020723  Prod. No.: 001 DISC (5%)
PatentsExpirationPatented Use
Pat. No. 7696159 DS* Treatment for basal cell carcinoma
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 12, 2010
Oct 1, 2024 *PEDU-1047: Treatment of biopsy-confirmed, primary superficial basal cell carcinoma (SBCC)
U-1048: Works through the induction of interferon and other cytokines

ALECENSA (CAPSULE) (ORAL) ALECTINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: HOFFMANN-LA ROCHE      NDA No.:
208434  Prod. No.: 001 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 9126931 DS* Tetracyclic compound
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 22, 2015
May 29, 2031 
Pat. No. 9365514 DP* Composition comprising tetracyclic compound
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 11, 2016
Mar 4, 2032 
Pat. No. 9440922 DP* Tetracyclic compound
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 12, 2016
Jun 9, 2030 
Pat. No. 10350214 DP* Preparation containing tetracyclic compound at high dose
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 9, 2020
Apr 24, 2035 
Pat. No. 11433076 DP* Preparation containing tetracyclic compound at high dose
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 28, 2022
Apr 24, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityNov 6, 2024ODE-159: For treatment of patients with anaplastic lymphoma kinase (ALK) positive, metastatic non-small-cell lung cancer (NSCLC) as detected by an FDA approved test, excluding patients who have progressed on or are intolerant to crizotinib

ALENDRONATE SODIUM (SOLUTION) (ORAL) ALENDRONATE SODIUM [GENERIC AA]
NDA Applicant: NOVITIUM PHARMA      NDA No.:
214512  Prod. No.: 001 RX (EQ 70MG BASE/75ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyNov 20, 2023 

ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HEALTHCARE      NDA No.:
209936  Prod. No.: 001 DISC (60MG/VIAL)
PatentsExpirationPatented Use
Pat. No. RE46856 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Claim Types: Compound; Composition; Kit; Method of use
Pat. Sub. Date(s): 001: Jun 15, 2018
Oct 22, 2029U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 7511041 DS* DP* Fused azole-pyrimidine derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 10, 2017
May 13, 2024 
Pat. No. 9636344 Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 10, 2017
Mar 29, 2032U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 10383876 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts
Claim Types: Compound; New polymorph, salt or hydrate; Process; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 18, 2019
Mar 29, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 14, 2024ODE-155: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies

ALKINDI SPRINKLE (GRANULE) (ORAL) HYDROCORTISONE
NDA Applicant: ETON      NDA No.:
213876  Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (2MG); 004 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 9649280 DP* Composition comprising hydrocortisone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2021
May 12, 2034U-3075: Treatment of adrenal insufficiency
Pat. No. 9675559 Treatment of adrenal insufficiency
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2021
Jan 10, 2033U-3075: Treatment of adrenal insufficiency
Pat. No. 9717740 Treatment of adrenal insufficiency
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2021
Nov 19, 2032U-3075: Treatment of adrenal insufficiency

ALLEGRA, CHILDREN'S ALLERGY; ALLEGRA, CHILDREN'S HIVES (SUSPENSION) (ORAL) FEXOFENADINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: CHATTEM SANOFI      NDA No.:
201373  Prod. No.: 001 OTC (30MG/5ML) NDA No.: 201373  Prod. No.: 002 DISC (30MG/5ML**)
PatentsExpirationPatented Use
Pat. No. 8933097 DP* Fexofenadine suspension formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 19, 2015
Aug 2, 2030 

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.:
021372  Prod. No.: 001 DISC (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)**)
PatentsExpirationPatented Use
Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 27, 2011
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 3, 2013
Jul 30, 2024 *PED 
Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8598219 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8729094 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 21, 2014
Jul 30, 2024 *PEDU-528: Prevention of chemotherapy-induced nausea and vomiting
Pat. No. 9066980 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 22, 2015
Jul 30, 2024 *PEDU-528: Prevention of chemotherapy-induced nausea and vomiting
Pat. No. 9125905 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation; Process; Drug in a container
Pat. Sub. Date(s): 001: Sep 9, 2015
Jul 30, 2024 *PED 
Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Sep 27, 2016
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Oct 25, 2016
Jul 30, 2024 *PED 
Pat. No. 9457021 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 25, 2016
Jul 30, 2024 *PED 

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 021372  Prod. No.: 002 DISC (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)**)
PatentsExpirationPatented Use
Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Sep 3, 2013
Jul 30, 2024 *PED 
Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Sep 27, 2016
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Oct 25, 2016
Jul 30, 2024 *PED 

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: ABBVIE      NDA No.:
021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 13, 2014
Mar 2, 2024 *PED 

ALSUMA (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: MERIDIAN MEDCL      NDA No.:
022377  Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 7811254 DP* Autoinjector with needle depth adapter
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Oct 13, 2010
Aug 26, 2027U-1083: Acute treatment of migraine attacks, with or without aura, and the treatment of cluster headache episodes

ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL      NDA No.:
022055  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 7875630 DS* Process salts compositions and use
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 001: Feb 10, 2011
Feb 14, 2027 
Pat. No. 8207191 Process, salts, composition and use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2016
Aug 30, 2024U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes

ALTRENO (LOTION) (TOPICAL) TRETINOIN
Drug Classes: retinoid
NDA Applicant: DOW PHARM      NDA No.:
209353  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 10653656 DP* Topical pharmaceutical compositions for treating skin conditions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 28, 2020
Aug 22, 2038U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older
Pat. No. 11324710 Topical pharmaceutical compositions for treating skin conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 8, 2022
Aug 22, 2038U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older

ALUNBRIG (TABLET) (ORAL) BRIGATINIB
Drug Classes: kinase inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
208772  Prod. No.: 001 RX (30MG); 002 RX (90MG); 003 RX (180MG)
PatentsExpirationPatented Use
Pat. No. 9012462 DS* [Extended 491 days (1.3 years)]
Phosphorous derivatives as kinase inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017
Apr 28, 2031 
Pat. No. 9273077 Phosphorus derivatives as kinase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017
May 21, 2029U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Pat. No. 9611283 Methods for inhibiting cell proliferation in ALK-driven cancers
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017
Apr 10, 2034U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Pat. No. 10385078 DS* DP* Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4-[4-(4-methylp- iperazin-1-YL) piperidin-1-YL]phenyl}pyrimidine-2,4-diamine
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Nov 10, 2035U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 28, 2024ODE-142: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2027ODE-300: For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, not including patients who have progressed on or are intolerant to crizotinib

ALVESCO (AEROSOL, METERED) (INHALATION) CICLESONIDE
NDA Applicant: COVIS      NDA No.:
021658  Prod. No.: 002 RX (0.08MG/INH); 003 RX (0.16MG/INH)
PatentsExpirationPatented Use
Pat. No. 8371292 Use of ciclesonide for the treatment of respiratory diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 1, 2028U-1355: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. patent claims method for treating a respiratory disease in a child

AMELUZ (GEL) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
NDA Applicant: BIOFRONTERA      NDA No.:
208081  Prod. No.: 001 RX (10%)
PatentsExpirationPatented Use
Pat. No. 11235169 Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Feb 23, 2022
Oct 15, 2040U-3303: Topical lesion-directed and field-directed treatment of actinic keratosis of the face and scalp with photodynamic therapy by positioning an illumination device in an appropriate distance and illuminating the treatment area with narrowband red light
Pat. No. 11540981 DP* Nanoemulsion formulation with improved stability and cell penetration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2023
Feb 7, 2028 

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.:
021908  Prod. No.: 001 RX (24MCG)
PatentsExpirationPatented Use
Pat. No. 8026393 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 26, 2011
Oct 25, 2027 
Pat. No. 8338639 DP* Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 20, 2012
Jan 23, 2027 
Pat. No. 8748481 Method for treating gastrointestinal disorder
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 20, 2014
Sep 1, 2025U-1520: Method for the long term treatment of chronic constipation in a human subject
Pat. No. 8779187 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 7, 2014
Jan 23, 2027 

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 002 RX (8MCG)
PatentsExpirationPatented Use
Pat. No. 7795312 Method for treating abdominal discomfort
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 17, 2024U-1085: Method for treating irritable bowel syndrome and method for treating abdominal discomfort associated with irritable bowel syndrome
Pat. No. 8026393 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Oct 25, 2027 
Pat. No. 8338639 DP* Soft-gelatin capsule formulation
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jan 23, 2027 
Pat. No. 8748481 Method for treating gastrointestinal disorder
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 20, 2014
Sep 1, 2025U-1519: Method for the long term treatment of chronic constipation in a human subject with irritable bowel syndrome
Pat. No. 8779187 DP* Soft-gelatin capsule formulation
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Aug 7, 2014
Jan 23, 2027 

AMONDYS 45 (SOLUTION) (INTRAVENOUS) CASIMERSEN
Drug Classes: antisense oligonucleotide
NDA Applicant: SAREPTA THERAPS INC      NDA No.:
213026  Prod. No.: 001 RX (100MG/2ML (50MG/ML))
PatentsExpirationPatented Use
Pat. No. RE48960 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Method of use; Formulation
Pat. Sub. Date(s): 001: Mar 31, 2022
Jun 28, 2025U-3087: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by inducing exon-skipping of exon 45
U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping
Pat. No. 9228187 DS* DP* Antisense molecules and methods for treating pathologies
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030 
Pat. No. 9447415 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 23, 2021
Jun 28, 2025 
Pat. No. 9758783 Antisense molecules and methods for treating pathologies
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping
U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production
Pat. No. 10287586 DS* DP* Antisense molecules and methods for treating pathologies
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030 
Pat. No. 10781450 Antisense molecules and methods for treating pathologies
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 23, 2021
Nov 12, 2030U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 25, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 25, 2028ODE-347: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping

AMPICILLIN TRIHYDRATE (CAPSULE) (ORAL) AMPICILLIN/AMPICILLIN TRIHYDRATE [Has competitive generic]
NDA Applicant: AUROBINDO PHARMA      NDA No.:
216554  Prod. No.: 001 RX (EQ 250MG BASE); 002 RX (EQ 500MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJun 3, 2024 

AMVUTTRA (SOLUTION) (SUBCUTANEOUS) VUTRISIRAN SODIUM
Drug Classes: transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC      NDA No.:
215515  Prod. No.: 001 RX (EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML))
PatentsExpirationPatented Use
Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Dec 12, 2029U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Dec 4, 2028U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 9370581 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Dec 4, 2028U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 9399775 DS* DP* RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases
Claim Types: Compound; Composition; Cell; Method of use; Kit
Pat. Sub. Date(s): 001: Jul 13, 2022
Nov 16, 2032U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Aug 24, 2028U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 10208307 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases
Claim Types: Compound; Cell; ; Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Jul 28, 2036U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 10570391 DS* DP* RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases
Claim Types: Compound; Cell; ; Composition; Method of use; Kit
Pat. Sub. Date(s): 001: Jul 13, 2022
Nov 16, 2032U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 10612024 DS* DP* Modified double-stranded RNA agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Aug 14, 2035U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 10683501 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Jul 28, 2036U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 10806791 DS* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 13, 2022
Dec 4, 2028 
Pat. No. 11286486 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Jul 28, 2036U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Pat. No. 11401517 DS* DP* Modified double-stranded RNA agents
Claim Types: Compound; Composition; Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 31, 2022
Aug 14, 2035U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 13, 2027 
Exclusivity Code: ODE - Orphan drug exclusivityJun 13, 2029ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

AMYVID (SOLUTION) (INTRAVENOUS) FLORBETAPIR F-18
NDA Applicant: AVID RADIOPHARMS INC      NDA No.:
202008  Prod. No.: 003 RX (10-50ML (13.5-51mCi/ML)) NDA No.: 202008  Prod. No.: 001 DISC (10ML (13.5-51mCi/ML)); 002 DISC (10-30ML (13.5-51mCi/ML))
PatentsExpirationPatented Use
Pat. No. 7687052 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Claim Types: Compound; Formulation; Diagnostic or surgical method
Pat. Sub. Date(s): 001: May 4, 2012; 002: None; 003: None
Apr 30, 2027 
Pat. No. 8506929 DS* DP* Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2013; 002: None; 003: None
Apr 30, 2027U-1423: Amyvid is a radioactive diagnostic agent for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment

AMZEEQ (AEROSOL, FOAM) (TOPICAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: JOURNEY      NDA No.:
212379  Prod. No.: 001 RX (EQ 4% BASE)
PatentsExpirationPatented Use
Pat. No. 8865139 DP* Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 8945516 DP* Surfactant-free water-free foamable compositions, breakable foams and gels and their uses
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030 
Pat. No. 8992896 DP* Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 9675700 DP* Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10086080 Topical tetracycline compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10137200 Surfactant-free water-free foamable compositions, breakable foams and gels and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10213512 DP* Topical tetracycline compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10265404 DP* Compositions, gels and foams with rheology modulators and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 15, 2019
Oct 1, 2030 
Pat. No. 10398641 Compositions and methods for treating rosacea and acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2019
Sep 8, 2037U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10517882 Method for healing of an infected acne lesion without scarring
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 10, 2020
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10821187 Compositions, gels and foams with rheology modulators and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2020
Oct 1, 2030U-2647: Treatment of non-nodular acne vulgaris
Pat. No. 10849847 Compositions and methods for treating rosacea and acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2020
Sep 8, 2037U-2647: Treatment of non-nodular acne vulgaris

ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: BESINS HLTHCARE      NDA No.:
022309  Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)) NDA No.: 022309  Prod. No.: 002 DISC (1.62% (20.25MG/1.25GM PACKET)**); 003 DISC (1.62% (40.5MG/2.5GM PACKET)**)
PatentsExpirationPatented Use
Pat. No. 8466136 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026 
Pat. No. 8466137 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466138 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8486925 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2013
Oct 12, 2026 
Pat. No. 8729057 DP* Testosterone gel and method of use
Claim Types: Composition
Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014
Oct 12, 2026 
Pat. No. 8741881 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2014
Oct 12, 2026U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8754070 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 16, 2014
Oct 12, 2026 
Pat. No. 8759329 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 9, 2014
Oct 12, 2026 

ANGELIQ (TABLET) (ORAL) DROSPIRENONE; ESTRADIOL
Drug Classes: progestin == estrogen
NDA Applicant: BAYER HLTHCARE      NDA No.:
021355  Prod. No.: 001 RX (0.25MG;0.5MG)
PatentsExpirationPatented Use
Pat. No. 8906890 DP* Very low-dosed solid oral dosage forms for HRT
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jan 8, 2015
Oct 22, 2031 

ANGIOMAX (INJECTABLE) (INTRAVENOUS) BIVALIRUDIN [GENERIC AP]
Drug Classes: anticoagulant == direct thrombin inhibitor
NDA Applicant: SANDOZ      NDA No.:
020873  Prod. No.: 001 RX (250MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7582727 DP* Pharmaceutical formulations of bivalirudin and processes of making the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 27, 2029 *PED 
Pat. No. 7598343 DP* Pharmaceutical formulations of bivalirudin and processes of making the same
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: None
Jan 27, 2029 *PED 

ANGIOMAX RTU (SOLUTION) (INTRAVENOUS) BIVALIRUDIN
Drug Classes: anticoagulant == direct thrombin inhibitor
NDA Applicant: MAIA PHARMS INC      NDA No.:
211215  Prod. No.: 001 RX (250MG/50ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 11903993 Ready-to-use bivalirudin compositions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 21, 2024
May 20, 2039U-3817: Use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)
Pat. No. 11918622 Ready-to-use Bivalirudin Compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 6, 2024
May 20, 2039U-3817: Use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)

ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUDAX      NDA No.:
210583  Prod. No.: 001 DISC (30MG/ML (30MG/ML)**)
PatentsExpirationPatented Use
Pat. No. 9974746 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 6, 2020
May 26, 2030 
Pat. No. 10463673 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10471067 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10709713 Nanoparticulate meloxicam formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2020
May 26, 2030U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10881663 Method of treating pain in elderly patients with mild renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2021
Mar 8, 2039U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment
Pat. No. 11253478 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Mar 4, 2022
May 26, 2030U-3318: Management of moderate-to-severe pain by injection
Pat. No. 11458145 Methods of administering intravenous meloxicam in a bolus dose
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2022
Mar 8, 2039U-3318: Management of moderate-to-severe pain by injection

ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug Classes: progestin/estrogen CHC
NDA Applicant: MAYNE PHARMA      NDA No.:
209627  Prod. No.: 001 RX (0.013MG/24HR;0.15MG/24HR)
PatentsExpirationPatented Use
Pat. No. 10632066 Method of providing birth control
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 29, 2020
Feb 1, 2039U-2786: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a vagina for up to thirteen 21/7-day (in/out) cycles
U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception
Pat. No. 10765628 Method of providing birth control
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2020
Feb 1, 2039U-2786: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a vagina for up to thirteen 21/7-day (in/out) cycles
U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception
Pat. No. 10780047 Method of providing birth control
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2020
Feb 1, 2039U-2786: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a vagina for up to thirteen 21/7-day (in/out) cycles
U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception
Pat. No. 10918649 DP* System for providing birth control
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 17, 2021
Jun 21, 2039 
Pat. No. 10925882 DP* System for providing birth control
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 24, 2021
Jun 21, 2039 
Pat. No. 10940157 DP* System for providing birth control
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 11, 2021
Jun 21, 2039 
Pat. No. 11529308 DP* System for providing birth control
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 21, 2022
Jun 21, 2039 
Pat. No. 11850251 System for providing birth control
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 1, 2024
Jun 21, 2039U-3785: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg of ethinyl estradiol for up to 1thirteen 21/7-day (in/out) cycles
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 

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. 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. 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. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Aug 5, 2028 *PED 
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. 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. 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. 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. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 26, 2014
Apr 11, 2031 *PED 
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. 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)

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

ANTIZOL (INJECTABLE) (INJECTION) FOMEPIZOLE
Drug Classes: antidote
NDA Applicant: PAR PHARM INC      NDA No.:
020696  Prod. No.: 001 DISC (1.5GM/1.5ML (1GM/ML)**)
PatentsExpirationPatented Use
Pat. No. 7553863 DS* DP* Ultrapure 4-methylpyrazole
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Jun 30, 2027 

APADAZ (TABLET) (ORAL) ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
NDA Applicant: ZEVRA THERAP      NDA No.:
208653  Prod. No.: 001 DISC (325MG;EQ 6.12MG BASE)
PatentsExpirationPatented Use
Pat. No. 8461137 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Mar 22, 2018
Feb 22, 2031 
Pat. No. 8748413 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 
Pat. No. 8828978 DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 
Pat. No. 9132125 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Pat. No. 9549923 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 22, 2018
Jul 1, 2030 

APADAZ (TABLET) (ORAL) ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
NDA Applicant: ZEVRA THERAP      NDA No.: 208653  Prod. No.: 002 DISC (325MG;EQ 4.08MG BASE); 003 DISC (325MG;EQ 8.16MG BASE)
PatentsExpirationPatented Use
Pat. No. 8461137 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Feb 22, 2031 
Pat. No. 8748413 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 10, 2030 
Pat. No. 8828978 DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 1, 2030 
Pat. No. 9132125 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 1, 2030U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Pat. No. 9549923 DS* DP* Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 25, 2019
Jul 1, 2030 

APHEXDA (POWDER) (SUBCUTANEOUS) MOTIXAFORTIDE ACETATE
NDA Applicant: BIOLINERX LTD      NDA No.:
217159  Prod. No.: 001 RX (EQ 62MG BASE/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 8, 2028 
Exclusivity Code: ODE - Orphan drug exclusivitySep 8, 2030ODE-442: To mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma

APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: aminoketone
NDA Applicant: BAUSCH      NDA No.:
022108  Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
PatentsExpirationPatented Use
Pat. No. 7241805 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7569610 Modified release formulations of a bupropion salt
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours
Pat. No. 7572935 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7585897 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7649019 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7662407 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 

APONVIE (EMULSION) (INTRAVENOUS) APREPITANT
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: HERON THERAPS INC      NDA No.:
216457  Prod. No.: 001 RX (32MG/4.4ML (7.2MG/ML))
PatentsExpirationPatented Use
Pat. No. 9561229 DP* Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 9808465 Emulsion formulations of aprepitant
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 9974742 DP* Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035 
Pat. No. 9974793 DP* Emulsion formulations of aprepitant
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035 
Pat. No. 9974794 DP* Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 10500208 DP* Emulsion formulations of aprepitant
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035 
Pat. No. 10624850 Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 10953018 Emulsion formulations of aprepitant
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035U-3440: A method of administering aprepitant for prevention of post-operative nausea and vomiting
Pat. No. 11173118 DP* Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 5, 2022
Sep 18, 2035 
Pat. No. 11744800 DP* Methods of use of emulsion formulations of an NK-1 receptor antagonist
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 2, 2023
Sep 18, 2035U-3690: A method for preventing of post-operative nausea and vomiting
Pat. No. 11878074 Methods of use of emulsion formulations of an NK-1 receptor antagonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 6, 2024
Sep 18, 2035U-3787: A method for preventing post-operative nausea and vomiting

APRETUDE (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibito
NDA Applicant: VIIV HLTHCARE      NDA No.:
215499  Prod. No.: 001 RX (600MG/3ML (200MG/ML))
PatentsExpirationPatented Use
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): 001: Jan 14, 2022
Apr 28, 2026 
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): 001: Jan 14, 2022
Apr 28, 2026 
Pat. No. 11224597 DP* Pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 10, 2022
Sep 15, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 21, 2026 

APRISO (CAPSULE, EXTENDED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: SALIX      NDA No.:
022301  Prod. No.: 001 RX (375MG)
PatentsExpirationPatented Use
Pat. No. 8865688 Compositions and methods for treatment of bowel diseases with granulated mesalamine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2014
May 1, 2030U-1310: For the maintenance of remission of ulcerative colitis

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. 8372431 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 17, 2030 
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. 9566244 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 8, 2017
Oct 23, 2028 
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. 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
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. 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. 10912781 DP* Pharmaceutical composition comprising licarbazepine acetate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Oct 23, 2028 
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

ARAKODA (TABLET) (ORAL) TAFENOQUINE SUCCINATE
NDA Applicant: 60 DEGREES PHARMS      NDA No.:
210607  Prod. No.: 001 RX (EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 10342791 Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Claim Types: Method of use (dosaage regimen); Kit
Pat. Sub. Date(s): 001: Jul 31, 2019
Dec 2, 2035U-2582: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose
Pat. No. 10888558 Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: Feb 10, 2021
Dec 2, 2035U-2582: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose
Pat. No. 11744828 Regimens of tafenoquine for prevention of malaria in malaria-naïve subjects
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 001: Oct 4, 2023
Dec 2, 2035U-2582: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 20, 2023 

ARAZLO (LOTION) (TOPICAL) TAZAROTENE
Drug Classes: retinoid
NDA Applicant: BAUSCH      NDA No.:
211882  Prod. No.: 001 RX (0.045%)
PatentsExpirationPatented Use
Pat. No. 11311482 Topical compositions and methods for treating skin diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 5, 2022
May 11, 2038U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older
Pat. No. 11679116 DP* Topical compositions and methods for treating psoriasis
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 13, 2023
Jun 6, 2036 

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 

ARGATROBAN IN SODIUM CHLORIDE (INJECTABLE) (INTRAVENOUS) ARGATROBAN
NDA Applicant: CIPLA      NDA No.:
022434  Prod. No.: 001 DISC (50MG/50ML (1MG/ML)**)
PatentsExpirationPatented Use
Pat. No. 7589106 DP* Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Jul 20, 2011
Sep 26, 2027U-1163: Method of treating thrombosis
Pat. No. 7687516 DP* Alcohol free formulation of argatroban
Claim Types: Formulation; Drug in a container; Method of administration; Method of use
Pat. Sub. Date(s): 001: Jul 20, 2011
Sep 26, 2027U-1164: Method of treating an argatroban treatable condition

ARICEPT (TABLET) (ORAL) DONEPEZIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: acetylcholinesterase inhibitor
NDA Applicant: EISAI INC      NDA No.:
022568  Prod. No.: 001 RX (23MG)
PatentsExpirationPatented Use
Pat. No. 8481565 DP* Method for stabilizing anti-dementia drug
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 9, 2013
Oct 4, 2026 

ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.:
207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
PatentsExpirationPatented Use
Pat. No. 7718189 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jun 6, 2025U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8226975 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Aug 15, 2028 
Pat. No. 8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen
Pat. No. 8642075 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026 
Pat. No. 8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8802137 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 9566234 DP* Systems for treating pulmonary infections
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jan 18, 2034U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9827317 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
May 15, 2035U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen
Pat. No. 10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 24, 2020
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 11446318 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2022
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2030 GAINODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.:
207533  Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 10, 2020
Mar 19, 2035U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia
Pat. No. 11406632 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Aug 19, 2022
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 002: Oct 14, 2015
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Oct 5, 2016
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 002: Jan 19, 2017
Mar 19, 2035 
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 10, 2020
Mar 19, 2035U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia
Pat. No. 11406632 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Aug 19, 2022
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 003: Oct 14, 2015
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Oct 5, 2016
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 003: Jan 19, 2017
Mar 19, 2035 
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2032U-543: Treatment of schizophrenia
Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 003: Nov 10, 2020
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 21, 2021
Oct 24, 2033U-764: Treatment of schizophrenia
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia
Pat. No. 11406632 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Aug 19, 2022
Mar 19, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.:
209830  Prod. No.: 001 RX (675MG/2.4ML (281.25MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 18, 2018
Oct 26, 2030 
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 18, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10016415 DP* Aripiprazole prodrug compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 18, 2018
Sep 8, 2035 
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 10688091 DP* Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 8, 2020
Aug 17, 2035 
Pat. No. 10849894 Aripiprazole prodrug composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2020
Aug 17, 2035U-543: Treatment of schizophrenia
Pat. No. 11154552 DP* Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2021
Aug 17, 2035 
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 13, 2022
Apr 6, 2039U-543: Treatment of schizophrenia

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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Sep 26, 2028 *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. 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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 20, 2020
Nov 19, 2025 *PED 
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. 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. 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. 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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 004: Oct 6, 2020
Nov 19, 2025 *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. 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. 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 
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. 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. 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 
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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Sep 26, 2028 *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. 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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 20, 2020
Nov 19, 2025 *PED 
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. 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. 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. 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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *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. 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. 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 
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. 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. 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 

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. 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. 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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 19, 2025 *PED 
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. 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. 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. 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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 008: May 5, 2022
Nov 19, 2025 *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. 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. 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 
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. 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. 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 

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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Sep 26, 2028 *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. 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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2017
Nov 19, 2025 *PED 
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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
Nov 19, 2025 *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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Sep 26, 2028 *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. 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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jan 30, 2017
Nov 19, 2025 *PED 
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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 6, 2020
Nov 19, 2025 *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. 8651103 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Sep 26, 2028 *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 
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. 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. 9463288 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 19, 2025 *PED 
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. 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. 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. 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. 10765820 DP* Dry powder inhalation apparatus
Claim Types: Device
Pat. Sub. Date(s): 007: Aug 5, 2021
Nov 19, 2025 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthJan 9, 2025 PED 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
205625  Prod. No.: 001 RX (0.1MG/INH)
PatentsExpirationPatented Use
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Feb 5, 2029 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 28, 2014
Apr 11, 2031 *PED 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 18, 2016
Apr 2, 2028 *PED 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 002 RX (0.2MG/INH)
PatentsExpirationPatented Use
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Apr 23, 2028 *PED 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Aug 5, 2028 *PED 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Sep 8, 2030 *PED 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 28, 2014
Apr 11, 2031 *PED 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 002: May 18, 2016
Apr 2, 2028 *PED 

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 003 RX (0.05MG/INH)
PatentsExpirationPatented Use
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Apr 23, 2028 *PED 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Aug 5, 2028 *PED 
Pat. No. 8201556 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Feb 5, 2029 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Sep 8, 2030 *PED 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 13, 2018
Apr 11, 2031 *PED 
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 003: Jun 13, 2018
Apr 2, 2028 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 1, 2026M-290: Information added to section 8.4 of the labeling to include the result of study HZA114971

ARTESUNATE (POWDER) (INTRAVENOUS) ARTESUNATE
NDA Applicant: AMIVAS      NDA No.:
213036  Prod. No.: 001 RX (110MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 26, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityMay 26, 2027ODE-290: Indicated for the initial treatment of severe malaria in adult and pediatric patients to always be followed by a complete treatment course of an appropriate oral antimalarial regimen

ARYMO ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: dopaminergic agonist == opioid agonist
NDA Applicant: ZYLA      NDA No.:
208603  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)
PatentsExpirationPatented Use
Pat. No. 9044402 DP* Abuse-deterrent pharmaceutical compositions for controlled release
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 8, 2017
Jul 1, 2033U-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. 9549899 DP* Abuse deterrent pharmaceutical compositions for controlled release
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 21, 2017
Jul 1, 2033U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

ASCOR (SOLUTION) (INTRAVENOUS) ASCORBIC ACID
NDA Applicant: MCGUFF      NDA No.:
209112  Prod. No.: 001 RX (25,000MG/50ML (500MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 2, 2024ODE-160: For treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated

ASPRUZYO SPRINKLE (GRANULES, EXTENDED RELEASE) (ORAL) RANOLAZINE
Drug Classes: antianginal
NDA Applicant: SPIL      NDA No.:
216018  Prod. No.: 001 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 11510878 DP* Extended release multiparticulates of ranolazine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 1, 2022
Jan 24, 2038 

ASPRUZYO SPRINKLE (GRANULES, EXTENDED RELEASE) (ORAL) RANOLAZINE
Drug Classes: antianginal
NDA Applicant: SPIL      NDA No.: 216018  Prod. No.: 002 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 10898444 DP* Extended release multiparticulates of ranolazine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 3, 2022
Jan 24, 2038 
Pat. No. 11510878 DP* Extended release multiparticulates of ranolazine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 1, 2022
Jan 24, 2038 

ASTAGRAF XL (CAPSULE, EXTENDED RELEASE) (ORAL) TACROLIMUS [GENERIC AB]
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS      NDA No.:
204096  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 5MG BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)May 24, 2025 

ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.:
022203  Prod. No.: 001 DISC (0.137MG/SPRAY**)
PatentsExpirationPatented Use
Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 15, 2011
Jun 4, 2028 
Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 18, 2013
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis

ASTEPRO (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 022203  Prod. No.: 002 DISC (0.2055MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Dec 15, 2011
Jun 4, 2028 
Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 18, 2013
Nov 22, 2025U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis
Pat. No. 9919050 DP* Compositions comprising azelastine
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 29, 2018
Nov 22, 2025 

ASTEPRO ALLERGY; ASTEPRO ALLERGY, CHILDREN'S (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAYER HLTHCARE      NDA No.:
213872  Prod. No.: 001 OTC (0.2055MG/SPRAY); 002 OTC (0.2055MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8071073 DP* Compositions comprising azelastine and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Jun 4, 2028 
Pat. No. 8518919 Compositions comprising azelastine and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Nov 22, 2025U-3166: OTC use: allergy symptom reliever; temporary relief of these symptoms due to hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing and itchy nose
Pat. No. 9919050 DP* Compositions comprising azelastine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 8, 2021
Nov 22, 2025 

ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.:
022560  Prod. No.: 001 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 7645459 DP* Dosage forms of bisphosphonates
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2010
Jan 9, 2028U-662: Treatment of osteoporosis in postmenopausal women
Pat. No. 7645460 DP* Dosage forms of risedronate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2010
Jan 9, 2028U-662: Treatment of osteoporosis in postmenopausal women
Pat. No. 8246989 DP* Dosage forms of bisphosphonates
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 28, 2012
Jan 16, 2026 

ATORVALIQ (SUSPENSION) (ORAL) ATORVASTATIN CALCIUM
Drug Classes: HMG-CoA reductase inhibitor
NDA Applicant: CMP DEV LLC      NDA No.:
213260  Prod. No.: 001 RX (20MG/5ML)
PatentsExpirationPatented Use
Pat. No. 11369567 DP* Aqueous suspension suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 7, 2023
Jun 7, 2037 
Pat. No. 11654106 DP* Aqueous suspension suitable for oral administration
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 1, 2023
Jun 7, 2037U-3612: As an adjunct to diet to reduce low-density lipoprotein cholesterol in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia
U-3613: As an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia

ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES      NDA No.:
021937  Prod. No.: 001 RX (600MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 8598185 DP* Unitary pharmaceutical dosage form
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 28, 2029 
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9018192 Unitary pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2015
Jun 13, 2026U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9545414 DP* Unitary pharmaceutical dosage form
Claim Types: Formulation; Method of use; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Feb 13, 2017
Jun 13, 2026U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-750: Treatment of HIV-1 infection in adults
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection

ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
021527  Prod. No.: 001 RX (0.021MG/INH)
PatentsExpirationPatented Use
Pat. No. 8474447 DP* Inhaler device
Claim Types: Device
Pat. Sub. Date(s): 001: May 28, 2015
Jan 17, 2030 

AUBAGIO (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.:
202992  Prod. No.: 001 RX (7MG); 002 RX (14MG)
PatentsExpirationPatented Use
Pat. No. 6794410 [Extended 1625 days (4.5 years)]
Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide for treating multiple sclerosis
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2013
Mar 12, 2027 *PEDU-1285: Treatment of patients with relapsing forms of multiple sclerosis
Pat. No. 8802735 DP* (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Claim Types: Formulation; Composition
Pat. Sub. Date(s): All strengths: Sep 11, 2014
Mar 14, 2031 *PED 
Pat. No. 9186346 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 15, 2015
Aug 4, 2034 *PEDU-1786: Treatment of patients with relapsing forms of multiple sclerosis while managing the risk of teriflunomide and rosuvastatin interaction by limiting the rosuvastatin dose to no more than 10mg and/or administering about half the normal dose
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 30, 2024 PEDM-61: Revisions to labeling based on data submitted in response to pediatric written request

AUGTYRO (CAPSULE) (ORAL) REPOTRECTINIB
NDA Applicant: BRISTOL      NDA No.:
218213  Prod. No.: 001 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 9714258 DS* DP* Diaryl macrocycles as modulators of protein kinases
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 12, 2023
Jan 23, 2035 
Pat. No. 10294242 DS* Diaryl macrocycle polymorph
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 12, 2023
Jul 5, 2036 
Pat. No. 11452725 Chiral diaryl macrocycles and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2023
Jul 24, 2036U-3755: Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityNov 15, 2030ODE-455: Treatment of adult patients with locally advanced or metastatic ros1-positive non-small cell lung cancer (NSCLC) with adenocarcinoma histology

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
NDA Applicant: KERYX BIOPHARMS      NDA No.:
205874  Prod. No.: 001 RX (EQ 210MG IRON)
PatentsExpirationPatented Use
Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2014
Apr 21, 2026U-1577: Control of serum phosphorous levels
Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 18, 2024 
Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 3, 2014
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2015
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 9, 2015
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 30, 2016
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9387191 DP* Ferric citrate dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2016
Jul 21, 2030 
Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2017
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 10300039 Ferric citrate dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 24, 2019
Jul 21, 2030U-2549: Control of serum phosphorus levels

AUSTEDO (TABLET) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
208082  Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)
PatentsExpirationPatented Use
Pat. No. 8524733 DS* DP* [Extended 562 days (1.5 years)]
Benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Oct 3, 2031 *PED 
Pat. No. 9233959 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Mar 18, 2034 *PED 
Pat. No. 9296739 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Mar 18, 2034 *PED 
Pat. No. 9550780 DS* DP* Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 4, 2017
Mar 18, 2034 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 9814708 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2017
Mar 18, 2034 *PED 
Pat. No. 10959996 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Mar 31, 2021
Sep 7, 2036 *PEDU-3055: A method of treating Huntington's chorea
Pat. No. 11179386 DP* Analogs of deutetrabenazine, their preparation and use
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2021
Sep 15, 2038 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 11357772 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 27, 2022
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 11446291 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Dosaage regimen
Pat. Sub. Date(s): All strengths: Oct 13, 2022
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
Pat. No. 11564917 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 15, 2023
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
Pat. No. 11648244 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 5, 2023
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
Pat. No. 11666566 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 16, 2023
Mar 18, 2034 *PED 
Pat. No. 11813232 DP* Analogs of deutetrabenazine, their preparation and use
Claim Types: Process; Product-by-process
Pat. Sub. Date(s): All strengths: Dec 7, 2023
Sep 15, 2038 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 24, 2024 PEDM-54: Information from pediatric studies added to label
Exclusivity Code: ODE - Orphan drug exclusivityOct 3, 2024 PEDODE-134: Treatment of chorea associated with Huntington's disease

AUSTEDO XR (TABLET, EXTENDED RELEASE) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA      NDA No.:
216354  Prod. No.: 001 RX (6MG); 002 RX (12MG); 003 RX (24MG)
PatentsExpirationPatented Use
Pat. No. 8524733 DS* DP* [Extended 562 days (1.5 years)]
Benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Oct 3, 2031 *PED 
Pat. No. 9550780 DS* DP* Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Mar 18, 2034 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 10959996 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Sep 7, 2036 *PEDU-3055: A method of treating Huntington's chorea
Pat. No. 11179386 DP* Analogs of deutetrabenazine, their preparation and use
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Sep 15, 2038 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 11311488 DP* Osmotic dosage forms comprising deutetrabenazine and methods of use thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Jun 10, 2041U-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 11357772 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
U-3055: A method of treating Huntington's chorea
Pat. No. 11446291 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Dosaage regimen
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
Pat. No. 11564917 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 27, 2023
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
Pat. No. 11648244 Methods for the treatment of abnormal involuntary movement disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 5, 2023
Sep 7, 2036 *PEDU-1995: Treatment of tardive dyskinesia
Pat. No. 11813232 DP* Analogs of deutetrabenazine, their preparation and use
Claim Types: Process; Product-by-process
Pat. Sub. Date(s): All strengths: Dec 7, 2023
Sep 15, 2038 *PED 

AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME      NDA No.:
215430  Prod. No.: 001 RX (105MG;45MG)
PatentsExpirationPatented Use
Pat. No. 8569328 DP* Compositions and methods comprising tilidine or related compounds and dextromethorphan
Claim Types: Composition; Method of use; Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Oct 29, 2033U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9168234 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9198905 Compositions and methods for reducing dextrorphan plasma levels and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9205083 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9238032 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9278095 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9314462 Compositions and methods for increasing dextromethorphan plasma levels and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9370513 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9375429 Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9408815 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9421176 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9457023 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9457025 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9474731 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9486450 Hydroxybupropion and related compounds as modulators of drug plasma levels
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9700528 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9700553 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9707191 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9763932 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9861595 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9867819 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 9968568 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10058518 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10064857 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10080727 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10092560 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10092561 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10105327 Compositions and methods for increasing the metabolic lifetime of dextromethorphane and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10105361 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10251879 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10463634 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10512643 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10548857 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10596167 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10772850 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10780064 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10780066 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 9, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10786469 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10786496 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10799497 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10806710 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10864209 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874663 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874664 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10874665 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10881624 Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10881657 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10894046 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10894047 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10898453 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10925842 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10933034 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10940124 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10945973 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966941 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966942 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Jan 7, 2040U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 10966974 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11020389 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11058648 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11090300 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11096937 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11123343 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11129826 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11141388 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11141416 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11147808 Method of decreasing the fluctuation index of dextromethorphan
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11185515 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11191739 DP* Bupropion as a modulator of drug activity
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11197839 DP* Bupropion as a modulator of drug activity
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11207281 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11213521 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11229640 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11234946 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11253491 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11253492 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11273133 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11273134 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11285118 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11285146 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11291638 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11291665 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11298351 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11298352 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11311534 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11344544 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11357744 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11364233 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11382874 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11419867 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11426370 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11426401 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11433067 DP* Bupropion as a modulator of drug activity
Claim Types: Composition; Method of administration; Formulation
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11439636 Bupropion as a modulator of drug activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 16, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11478468 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 10, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11497721 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 2, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11510918 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11517542 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11517543 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11524007 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11524008 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 21, 2022
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11534414 DP* Bupropion as a modulator of drug activity
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11541021 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11541048 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 23, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11596627 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 4, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11617728 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 3, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11617747 Bupropion as a modulator of drug activity
Claim Types: Method of use; Method of improving a treatment
Pat. Sub. Date(s): 001: May 3, 2023
Nov 5, 2034U-3563: Dextromethorphan and bupropion in combination to increase dextromethorphan plasma levels
Pat. No. 11717518 Bupropion Dosage Forms With Reduced Food And Alcohol Dosing Effects
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 15, 2023
Jan 20, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11730706 Treatment of depression in certain patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 28, 2023
Jan 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11752144 Compounds and combinations thereof for treating neurological and psychiatric conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2023
Feb 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11779579 Bupropion as a modulator of drug activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 12, 2023
Nov 5, 2034U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11839612 Compounds and combinations thereof for treating neurological and psychiatric conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2024
Mar 2, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11844797 Combination of dextromethorphan and bupropion for treating depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2024
Apr 20, 2043U-3778: Treatment of major depressive disorder by administering dextromethorphan and bupropion to a subject having moderate hepatic impairment
Pat. No. 11883373 Treatment of depression in certain patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 8, 2024
Jan 23, 2043U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Pat. No. 11896563 Bupropion and dextromethorphan for reduction of suicide risk in depression patients
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2024
Dec 1, 2041U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 18, 2025 

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.:
201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 12, 2028 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 21, 2013
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2012
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 21, 2012
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2012
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2013
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2014
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 25, 2020
Nov 23, 2024 
Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2023
Dec 12, 2026 

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 12, 2028 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 15, 2014
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 25, 2020
Nov 23, 2024 
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 29, 2023
Dec 12, 2026 
Pat. No. 11771830 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Dec 20, 2023
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 12, 2028 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9833573 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs)
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Aug 25, 2020
Nov 23, 2024 
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 29, 2023
Dec 12, 2026 
Pat. No. 11771830 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Dec 20, 2023
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector

AVACLYR (OINTMENT) (OPHTHALMIC) ACYCLOVIR
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibi
NDA Applicant: FERA PHARMS LLC      NDA No.:
202408  Prod. No.: 001 DISC (3%**)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 29, 2026ODE-235: Indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus

AVEED (INJECTABLE) (INTRAMUSCULAR) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: ENDO PHARMS INC      NDA No.:
022219  Prod. No.: 001 RX (750MG/3ML (250MG/ML))
PatentsExpirationPatented Use
Pat. No. 7718640 DP* Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Mar 14, 2027 
Pat. No. 8338395 [Extended 435 days (1.2 years)]
Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: None
May 8, 2027U-1500: Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired); hypogonadotropic hypogonadism (congenital or acquired).

AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == cephalosporin antibacterial
NDA Applicant: ALLERGAN      NDA No.:
206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
PatentsExpirationPatented Use
Pat. No. 7112592 DS* DP* [Extended 1413 days (3.9 years)]
Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Jan 7, 2026U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium
U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections
U-3818: Treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adult and pediatric patients (at least 31 weeks gestational age)
Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Nov 12, 2026 
Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 17, 2015
Aug 12, 2031 
Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Oct 8, 2030 
Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 17, 2015
Jun 15, 2032 
Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Feb 24, 2017
Jun 15, 2032 
Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Formulation; Compound; Composition
Pat. Sub. Date(s): 001: Aug 8, 2017
Jun 15, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 25, 2025 GAIN 
Exclusivity Code: NPP - New patient populationDec 20, 2025 

AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO      NDA No.:
022504  Prod. No.: 001 DISC (30MG/1.5ML ACTUATION**)
PatentsExpirationPatented Use
Pat. No. 8419307 Spreading implement
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 30, 2013
Feb 26, 2027U-1386: A method of increasing the testosterone blood level of a person in need thereof
Pat. No. 8435944 Method and composition for transdermal drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Sep 27, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 8807861 DP* Spreading implement
Claim Types: Device; Drug in a container; Method of use
Pat. Sub. Date(s): 001: Sep 10, 2014
Feb 26, 2027U-1563: A method of transdermal administration of a physiologically active agent to a subject.
Pat. No. 8993520 Method and composition for transdermal drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 9, 2015
Jun 2, 2026U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 9180194 Method and composition for transdermal drug delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 3, 2015
Jun 2, 2026U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof
Pat. No. 9289586 Spreading implement
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2016
Feb 26, 2027U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof

AXUMIN (SOLUTION) (INTRAVENOUS) FLUCICLOVINE F-18
NDA Applicant: BLUE EARTH      NDA No.:
208054  Prod. No.: 001 RX (9-221mCi/ML)
PatentsExpirationPatented Use
Pat. No. 9387266 Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: Jul 28, 2016
Nov 28, 2026U-1879: Method of diagnosing tumors using positron emission tomography
Pat. No. 10010632 DP* Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 27, 2018
Nov 28, 2026 
Pat. No. 10124079 Imaging of metastatic or recurrent cancer
Claim Types: Method of administration; Diagnostic or surgical method
Pat. Sub. Date(s): 001: Dec 12, 2018
Dec 30, 2035U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment
Pat. No. 10716868 Imaging of metastatic or recurrent cancer
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 22, 2020
Dec 30, 2035U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment
Pat. No. 10933147 Imaging of metastatic or recurrent cancer
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 9, 2021
Dec 30, 2035U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment
Pat. No. 10953112 Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Apr 20, 2021
Nov 28, 2026U-1879: Method of diagnosing tumors using positron emission tomography
Pat. No. 10967077 Imaging of metastatic or recurrent cancer
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: Apr 20, 2021
Dec 30, 2035U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.:
212608  Prod. No.: 001 RX (100MG); 002 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 9200002 DS* DP* Compositions useful for treating disorders related to KIT
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9944651 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9994575 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 16, 2024I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN)
Exclusivity Code: I - New IndicationJun 16, 2024I-864: Treatment of adult patients with mast cell leukemia (MCL)
Exclusivity Code: NCE - New chemical entityJan 9, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 16, 2028ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2027ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 003 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 9200002 DS* DP* Compositions useful for treating disorders related to KIT
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
Pat. No. 9944651 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
Pat. No. 9994575 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Feb 5, 2020
Oct 15, 2034U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 9, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 16, 2028ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2027ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 004 RX (25MG)
PatentsExpirationPatented Use
Pat. No. 9200002 DS* DP* Compositions useful for treating disorders related to KIT
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 004: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
U-3506: Treatment of indolent systemic mastocytosis (ISM)
Pat. No. 9944651 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 004: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
U-3506: Treatment of indolent systemic mastocytosis (ISM)
Pat. No. 9994575 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 004: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
U-3506: Treatment of indolent systemic mastocytosis (ISM)
Pat. No. 11827642 DS* DP* Compositions useful for treating disorders related to KIT
Claim Types: Method of use
Pat. Sub. Date(s): 004: Dec 21, 2023
Oct 15, 2034U-3506: Treatment of indolent systemic mastocytosis (ISM)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 16, 2024I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN)
Exclusivity Code: I - New IndicationJun 16, 2024I-864: Treatment of adult patients with mast cell leukemia (MCL)
Exclusivity Code: I - New IndicationMay 22, 2026I-912: Treatment of adult patients with indolent systemic mastocytosis (ISM)
Exclusivity Code: NCE - New chemical entityJan 9, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 16, 2028ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2027ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 005 RX (50MG)
PatentsExpirationPatented Use
Pat. No. 9200002 DS* DP* Compositions useful for treating disorders related to KIT
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 005: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9944651 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 005: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Pat. No. 9994575 DS* DP* Compositions useful for treating disorders related to kit
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 005: Jul 13, 2021
Oct 15, 2034U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 16, 2024I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN)
Exclusivity Code: I - New IndicationJun 16, 2024I-864: Treatment of adult patients with mast cell leukemia (MCL)
Exclusivity Code: NCE - New chemical entityJan 9, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 16, 2028ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2027ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations
Exclusivity Code: ODE - Orphan drug exclusivityMay 22, 2030ODE-434: Treatment of adult patients with indolent systemic mastocytosis (ISM)

AZEDRA (SOLUTION) (INTRAVENOUS) IOBENGUANE I-131
NDA Applicant: PROGENICS PHARMS INC      NDA No.:
209607  Prod. No.: 001 DISC (15mCi/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJul 30, 2025ODE-204: Treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy

AZILECT (TABLET) (ORAL) RASAGILINE MESYLATE [GENERIC AB]
Drug Classes: monoamine oxidase inhibitor (MAOI)
NDA Applicant: TEVA      NDA No.:
021641  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)
PatentsExpirationPatented Use
Pat. No. 7572834 DP* Rasagiline formulations and processes for their preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 5, 2026 
Pat. No. 7815942 DS* DP* Rasagiline formulations of improved content uniformity
Claim Types: Formulation; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Nov 8, 2010; 002: None
Aug 27, 2027U-219: Treatment of Parkinson's disease

AZSTARYS (CAPSULE) (ORAL) DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Drug Classes: central nervous system stimulant
NDA Applicant: COMMAVE THERAP      NDA No.:
212994  Prod. No.: 001 RX (EQ 5.2MG BASE;EQ 26.1MG BASE); 002 RX (EQ 7.8MG BASE;EQ 39.2MG BASE); 003 RX (EQ 10.4MG BASE;EQ 52.3MG BASE)
PatentsExpirationPatented Use
Pat. No. 9079928 DP* Methylphenidate-oxoacid conjugates, processes of making and using the same
Claim Types: Composition
Pat. Sub. Date(s): All strengths: May 17, 2021
Jul 27, 2032 
Pat. No. 10584112 DS* DP* Methylphenidate-prodrugs, processes of making and using the same
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: May 17, 2021
Dec 9, 2037 
Pat. No. 10584113 DP* Methylphenidate-prodrugs, processes of making and using the same
Claim Types: Composition
Pat. Sub. Date(s): All strengths: May 17, 2021
Dec 9, 2037 
Pat. No. 10759778 DP* Methylphenidate-prodrugs, processes of making and using the same
Claim Types: Kit
Pat. Sub. Date(s): All strengths: May 17, 2021
Dec 9, 2037 
Pat. No. 10858341 Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 17, 2021
Dec 9, 2037U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate
Pat. No. 10954213 Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 17, 2021
Dec 9, 2037U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 7, 2026 


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Last edited: 11 March 2024
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