Orange Book Companion®
Patent Expiration View
Products whose next patent expiration is in 2022

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.


OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 209637  Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML))
PatentsExpirationPatented Use
Pat. No. 6899699 DP* Automatic injection device with reset feature
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Dec 20, 2017
Jan 2, 2022 
Pat. No. 8672898 DP* Automatic injection device with reset feature
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jan 2, 2022 
Pat. No. 9486588 DP* Automatic injection device with reset feature
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jan 2, 2022 
Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jun 30, 2023 
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
May 23, 2024 
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 20, 2017
Aug 13, 2025 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Oct 20, 2025 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jan 20, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 17, 2018
Jan 20, 2026 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 17, 2018
Jan 20, 2026 
Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 8, 2019
Jan 20, 2026 
Pat. No. 10376652 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 13, 2019
Jan 20, 2026 
Pat. No. 11311679 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: May 20, 2022
Jan 20, 2026 
Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Mar 20, 2026U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jul 17, 2026 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Jul 17, 2026 
Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 4, 2019
Jul 17, 2026 
Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 21, 2021
Jul 17, 2026 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Aug 3, 2026 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Feb 27, 2027 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Sep 27, 2027 
Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)]
Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Dec 5, 2031U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2017
Feb 1, 2032 
Pat. No. 10335462 Use of long-acting GLP-1 peptides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Jun 21, 2033U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 16, 2023I-822: Reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease
Exclusivity Code: NCE - New chemical entityDec 5, 2022 

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 209637  Prod. No.: 002 RX (4MG/3ML (1.34MG/ML))
PatentsExpirationPatented Use
Pat. No. 6899699 DP* Automatic injection device with reset feature
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 2, 2022 
Pat. No. 8672898 DP* Automatic injection device with reset feature
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 2, 2022 
Pat. No. 9486588 DP* Automatic injection device with reset feature
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 2, 2022 
Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jun 30, 2023 
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
May 23, 2024 
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Sep 24, 2020
Aug 13, 2025 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Oct 20, 2025 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 10376652 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jan 20, 2026 
Pat. No. 11311679 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: May 20, 2022
Jan 20, 2026 
Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Sep 24, 2020
Mar 20, 2026U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jul 17, 2026 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jul 17, 2026 
Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Jul 17, 2026 
Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Sep 21, 2021
Jul 17, 2026 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: Dec 21, 2020
Aug 3, 2026 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Feb 27, 2027 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Sep 29, 2027 
Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)]
Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Sep 24, 2020
Dec 5, 2031U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 21, 2020
Feb 1, 2032 
Pat. No. 10335462 Use of long-acting GLP-1 peptides
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 24, 2020
Jun 21, 2033U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 16, 2023I-822: Reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease
Exclusivity Code: NCE - New chemical entityDec 5, 2022 

BAQSIMI (POWDER) (NASAL) GLUCAGON
Drug Classes: Blood Glucose Regulators:Glycemic Agents == antihypoglycemic agent == gastrointestinal motility inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 210134  Prod. No.: 001 RX (3MG)
PatentsExpirationPatented Use
Pat. No. 6938798 DP* Fluid or powdery product dispensing device
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 23, 2019
Jan 3, 2022 
Pat. No. 10213487 DP* Nasal powder formulation for treatment of hypoglycemia
Claim Types: Formulation; Process; Device; Method of use
Pat. Sub. Date(s): 001: Aug 23, 2019
Feb 16, 2036U-2604: Treatment of severe hypoglycemia in patients with diabetes
Pat. No. 10894133 DP* Device for dispensing a fluid product
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 10, 2021
Jan 3, 2038 
Pat. No. 10765602 DP* Medication delivery systems and methods
Claim Types: Device; Method of administration; Container
Pat. Sub. Date(s): 001: Oct 8, 2020
Sep 23, 2039 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 24, 2022 

CLOBEX (SHAMPOO) (TOPICAL) CLOBETASOL PROPIONATE [GENERIC AB]
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == corticosteroid
NDA Applicant: GALDERMA LABS      NDA No.: 021644  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 7700081 Foaming compositions for hair care
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 3, 2022U-1044: Topical treatment of scalp psoriasis

GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: ALNYLAM PHARMS INC      NDA No.: 212194  Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8546143 DS* Compositions and methods for inhibiting expression of a target gene
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Jan 9, 2022U-2672: Treatment of acute hepatic porphyria
Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Jan 1, 2024U-2672: Treatment of acute hepatic porphyria
Pat. No. 9708615 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 8, 2024 
Pat. No. 10273477 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 8, 2024 
Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition
Pat. Sub. Date(s): 001: Dec 12, 2019
Aug 28, 2025 
Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Aug 24, 2028U-2672: Treatment of acute hepatic porphyria
Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Dec 4, 2028U-2672: Treatment of acute hepatic porphyria
Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Dec 12, 2029U-2672: Treatment of acute hepatic porphyria
Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 15, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate
Pat. Sub. Date(s): 001: Dec 12, 2019
Mar 15, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 9133461 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019
May 14, 2033U-2672: Treatment of acute hepatic porphyria
Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 12, 2019
Oct 3, 2034U-2672: Treatment of acute hepatic porphyria
Pat. No. 11028392 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Feb 16, 2022
Oct 3, 2034U-2672: Treatment of acute hepatic porphyria
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 20, 2024 
Exclusivity Code: ODE - Orphan drug exclusivityNov 20, 2026ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP)

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AT]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021262  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented Use
Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 

ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 10, 2017
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
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 

ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021393  Prod. No.: 001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
PatentsExpirationPatented Use
Pat. No. 8883849 Treatment of sleep disturbances
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2014
Jan 17, 2022U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient
Pat. No. 9155718 DP* Treatment of sleep disturbances
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2015
Jan 17, 2022 

ESBRIET (TABLET) (ORAL) PIRFENIDONE [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Fibrosis Agents == pyridone
NDA Applicant: GENENTECH INC      NDA No.: 208780  Prod. No.: 001 RX (267MG); 003 RX (801MG)
PatentsExpirationPatented Use
Pat. No. 9561217 DP* Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 25, 2022 
Pat. No. 7767700 Method of providing pirfenidone therapy to a patient
Claim Types: Method of administration; Method of improving a treatment
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Dec 18, 2027U-2080: Pirfenidone dose escalation regimen for treatment of IPF as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen
Pat. No. 8420674 Method of providing pirfenidone therapy to a patient
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Dec 18, 2027U-2079: Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen
Pat. No. 8383150 DP* [Extended 596 days (1.6 years)]
Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2017
May 10, 2028U-2361: Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis
Pat. No. 7566729 Modifying pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Apr 22, 2029U-2077: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400 mg/day dose then full day daily dose in treatment of IPF
U-2078: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within limits, then sub-2400mg/day dose, then full daily dose in treatment of IPF
Pat. No. 7635707 Pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Apr 22, 2029U-2072: Full daily dosing following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF
U-2073: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering full daily dose in treatment of IPF
U-2074: Dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF
U-2075: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits followed by administering 1602 mg/day in treatment of IPF
U-2076: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering 801 mg/day followed by administering 1602 mg/day in treatment of IPF
U-2083: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by 801 mg/day, dose, then 1602 mg/day in treatment of IPF
Pat. No. 8592462 Pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Apr 22, 2029U-2055: Dosing of at least 1600 mg/day following grade 2 liver abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF
U-2056: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-1600 mg/day, following by administering at least 1600 mg/day in treatment of IPF
U-2057: Dosing 2403 mg/day pirfenidone following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF
U-2058: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-2400mg/day dose, followed by administering 2403mg/day in treatment of IPF
U-2059: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose in treatment of IPF
U-2060: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then at least 1600mg/day in treatment of IPF
U-2061: Dosing of at least 1600 mg/day following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF
U-2062: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-1600 mg/day dose, followed by administering at least 1600 mg/day dose in treatment of IPF
U-2063: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering at least 1600 mg/day in treatment of IPF
Pat. No. 8609701 Pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Apr 22, 2029U-2064: Dosing at least 1602 mg/day following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration
U-2065: Full daily dosing following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration
U-2066: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering sub-2400 mg/day dose, followed by full daily dose
U-2067: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone, followed by administering at least 1602 mg/day
U-2068: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose
U-2069: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering a sub-1600 mg/day dose, followed by administering at least 1602 mg/day
U-2070: Dosage modification following grade 2 abnormality in biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then sub-1600 mg/day, then at least 1602 mg/day
Pat. No. 7816383 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 8, 2030U-2042: Discontinuing administration of fluvoxamine to avoid drug interactions with pirfenidone and then administering pirfenidone
U-2050: Administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone
Pat. No. 7910610 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 8, 2030U-2048: Administering pirfenidone while avoiding co-administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone
U-2049: Discontinuing administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone
Pat. No. 8013002 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 8, 2030U-2047: Administering pirfenidone concurrently with fluvoxamine, the pirfenidone at a dose of about 801 mg/day to reduce drug interactions with fluvoxamine
U-2082: Modifying pirfenidone administration from a dose of about 2400 mg/day downward by about 1600 mg/day while co-administering fluvoxamine to reduce drug interactions with fluvoxamine
Pat. No. 8084475 Pirfenidone therapy and inducers of cytochrome P450
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 8, 2030U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone
U-2054: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2 to avoid reduced pirfenidone efficacy
Pat. No. 8318780 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 8, 2030U-2046: Administering pirfenidone while avoiding concomitant use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, AND CYP2D6
U-2081: Discontinuing use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, and CYP2D6 and then administering pirfenidone
Pat. No. 8648098 Pirfenidone therapy and inducers of cytochrome P450
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 8, 2030U-2051: Discontinuing smoking to avoid reduced pirfenidone efficacy and then administering pirfenidone
U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone
Pat. No. 8754109 Pirfenidone therapy and inducers of cytochrome P450
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Jan 8, 2030U-2053: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2, including cigarette smoke, to avoid reduced pirfenidone efficacy
Pat. No. 8778947 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Aug 30, 2033U-2044: Dose reduction of pirfenidone by about one half during concurrent administration of ciprofloxacin at a dose of 750 mg twice daily (1500 mg/day) to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder
U-2045: Administration of pirfenidone and avoiding concurrent administration of ciprofloxacin at a dose of 750 mg to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder
Pat. No. 10188637 DP* Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 25, 2019
Mar 28, 2037 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 15, 2021ODE-77: Treatment of idiopathic pulmonary fibrosis

ESBRIET (TABLET) (ORAL) PIRFENIDONE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Fibrosis Agents == pyridone
NDA Applicant: GENENTECH INC      NDA No.: 208780  Prod. No.: 002 DISC (534MG**)
PatentsExpirationPatented Use
Pat. No. 9561217 DP* Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 25, 2022 
Pat. No. 7767700 Method of providing pirfenidone therapy to a patient
Claim Types: Method of administration; Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 8, 2018
Dec 18, 2027U-2080: Pirfenidone dose escalation regimen for treatment of IPF as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen
Pat. No. 8420674 Method of providing pirfenidone therapy to a patient
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Dec 18, 2027U-2079: Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen
Pat. No. 8383150 DP* [Extended 596 days (1.6 years)]
Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 8, 2018
May 10, 2028U-2361: Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis
Pat. No. 7566729 Modifying pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Apr 22, 2029U-2269: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400mg/day dose then full daily dose in treatment of IPF
U-2270: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, then sub-2400mg/day dose, then full daily dose in treatment of IPF
Pat. No. 7635707 Pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Apr 22, 2029U-2072: Full daily dosing following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF
U-2073: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering full daily dose in treatment of IPF
U-2074: Dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF
U-2075: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits followed by administering 1602 mg/day in treatment of IPF
U-2076: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering 801 mg/day followed by administering 1602 mg/day in treatment of IPF
U-2083: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by 801 mg/day, dose, then 1602 mg/day in treatment of IPF
Pat. No. 8592462 Pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Apr 22, 2029U-2055: Dosing of at least 1600 mg/day following grade 2 liver abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF
U-2056: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-1600 mg/day, following by administering at least 1600 mg/day in treatment of IPF
U-2057: Dosing 2403 mg/day pirfenidone following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF
U-2058: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-2400mg/day dose, followed by administering 2403mg/day in treatment of IPF
U-2059: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose in treatment of IPF
U-2060: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then at least 1600mg/day in treatment of IPF
U-2061: Dosing of at least 1600 mg/day following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF
U-2062: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-1600 mg/day dose, followed by administering at least 1600 mg/day dose in treatment of IPF
U-2063: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering at least 1600 mg/day in treatment of IPF
Pat. No. 8609701 Pirfenidone treatment for patients with atypical liver function
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Apr 22, 2029U-2064: Dosing at least 1602 mg/day following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration
U-2065: Full daily dosing following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration
U-2066: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering sub-2400 mg/day dose, followed by full daily dose
U-2067: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone, followed by administering at least 1602 mg/day
U-2068: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose
U-2069: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering a sub-1600 mg/day dose, followed by administering at least 1602 mg/day
U-2070: Dosage modification following grade 2 abnormality in biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then sub-1600 mg/day, then at least 1602 mg/day
Pat. No. 7816383 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 8, 2030U-2042: Discontinuing administration of fluvoxamine to avoid drug interactions with pirfenidone and then administering pirfenidone
U-2050: Administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone
Pat. No. 7910610 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 8, 2030U-2048: Administering pirfenidone while avoiding co-administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone
U-2049: Discontinuing administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone
Pat. No. 8013002 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 8, 2030U-2047: Administering pirfenidone concurrently with fluvoxamine, the pirfenidone at a dose of about 801 mg/day to reduce drug interactions with fluvoxamine
U-2082: Modifying pirfenidone administration from a dose of about 2400 mg/day downward by about 1600 mg/day while co-administering fluvoxamine to reduce drug interactions with fluvoxamine
Pat. No. 8084475 Pirfenidone therapy and inducers of cytochrome P450
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 8, 2030U-2054: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2 to avoid reduced pirfenidone efficacy
U-2268: Discontinuing a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone
Pat. No. 8318780 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 8, 2030U-2046: Administering pirfenidone while avoiding concomitant use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, AND CYP2D6
U-2081: Discontinuing use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, and CYP2D6 and then administering pirfenidone
Pat. No. 8648098 Pirfenidone therapy and inducers of cytochrome P450
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 8, 2030U-2051: Discontinuing smoking to avoid reduced pirfenidone efficacy and then administering pirfenidone
U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone
Pat. No. 8754109 Pirfenidone therapy and inducers of cytochrome P450
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 8, 2018
Jan 8, 2030U-2053: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2, including cigarette smoke, to avoid reduced pirfenidone efficacy
Pat. No. 8778947 Methods of administering pirfenidone therapy
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 8, 2018
Aug 30, 2033U-2044: Dose reduction of pirfenidone by about one half during concurrent administration of ciprofloxacin at a dose of 750 mg twice daily (1500 mg/day) to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder
U-2045: Administration of pirfenidone and avoiding concurrent administration of ciprofloxacin at a dose of 750 mg to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder
Pat. No. 10188637 DP* Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 25, 2019
Mar 28, 2037 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 15, 2021ODE-77: Treatment of idiopathic pulmonary fibrosis

ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == 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. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
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. 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
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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 6977257 DP* Aripiprazole oral solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 24, 2022 *PED 
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
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. 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
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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
PatentsExpirationPatented Use
Pat. No. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 28, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8642600 Method of treating autism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Jul 28, 2022 *PEDU-1492: Treatment of irritability associated with autistic disorder
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Jun 30, 2016
Sep 25, 2022U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Mar 25, 2023 *PED 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Mar 5, 2014
Mar 25, 2023 *PED 
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2016
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 12, 2021ODE-80: Treatment of pediatric patients with Tourette's

ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == 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. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 26, 2015
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 8993761 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: Apr 28, 2015
Sep 25, 2022 
Pat. No. 8338428 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: None
Aug 6, 2023U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
U-543: Treatment of schizophrenia
Pat. No. 8759351 DP* Methods for administering aripiprazole
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2014
Aug 6, 2023U-1530: Use of aripiprazole in extended release injectable suspension
U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia
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. 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. 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. 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. 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

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == 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. 7053092 5-HT1a receptor subtype agonist
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jan 28, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jan 28, 2022U-543: Treatment of schizophrenia
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022 
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022 
Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Sep 25, 2022U-1529: Adjunctive treatment of major depressive disorder (MDD)
U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9387182 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
Dec 25, 2023U-1529: Adjunctive treatment of major depressive disorder (MDD)
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. 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. 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. 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. 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. 9119554 DP* Pharma-informatics system
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 16, 2028 
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. 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. 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. 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. 10441194 DP* Ingestible event marker systems
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 1, 2019
Jul 26, 2029 
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. 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. 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. 9149577 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Dec 15, 2029 
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. 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. 8114021 DP* Body-associated receiver and method
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Jun 21, 2030 
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. 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. 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. 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. 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. 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. 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. 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

BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 210251  Prod. No.: 001 RX (EQ 50MG BASE;200MG;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 26, 2018
Feb 2, 2022U-257: Treatment of HIV infection
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Feb 26, 2018
Oct 17, 2025 *PED 
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Feb 26, 2018
Feb 15, 2033 *PEDU-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 26, 2018
Feb 15, 2033 *PEDU-257: Treatment of HIV infection
Pat. No. 9216996 DS* DP* Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepin- es and methods for treating viral infections
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Feb 26, 2018
Dec 19, 2033 
Pat. No. 9732092 DS* DP* Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]OXAZEPINES and methods for treating viral infections
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Feb 26, 2018
Dec 19, 2033 
Pat. No. 9708342 DS* DP* Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Feb 26, 2018
Jun 19, 2035 
Pat. No. 10385067 Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxa- zepin-8-olate
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 30, 2019
Jun 19, 2035U-257: Treatment of HIV infection
Pat. No. 10548846 DP* Therapeutic compositions for treatment of human immunodeficiency virus
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 28, 2020
Nov 8, 2036 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 24, 2024M-82: Labeling revisions related to clinical studies
Exclusivity Code: NCE - New chemical entityFeb 7, 2023 
Exclusivity Code: NPP - New patient populationJun 18, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityJun 18, 2026ODE-256: For HIV-1 infection in pediatric pts at least 25 kg w/ no antiretroviral (ARV) tx hx or to replace current ARV regimen for virologically-suppressed on stable ARV w/ no hx tx failure and no known substitutions associated w/ resistance to BIC, FTC, or TAF

BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 210251  Prod. No.: 002 RX (EQ 30MG BASE;120MG;EQ 15MG BASE)
PatentsExpirationPatented Use
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 28, 2021
Feb 2, 2022U-257: Treatment of HIV infection
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 002: Oct 28, 2021
Apr 17, 2025 
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 002: Oct 28, 2021
Aug 15, 2032U-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 28, 2021
Aug 15, 2032U-257: Treatment of HIV infection
Pat. No. 9216996 DS* DP* Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepin- es and methods for treating viral infections
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Oct 28, 2021
Dec 19, 2033 
Pat. No. 9732092 DS* DP* Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]OXAZEPINES and methods for treating viral infections
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Oct 28, 2021
Dec 19, 2033 
Pat. No. 9708342 DS* DP* Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 002: Oct 28, 2021
Jun 19, 2035 
Pat. No. 10385067 Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxa- zepin-8-olate
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 28, 2021
Jun 19, 2035U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 7, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityOct 7, 2028ODE-378: A complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing 14 kg to less than 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY

DESCOVY (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208215  Prod. No.: 001 RX (200MG;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2016
Feb 2, 2022U-1663: Treatment of HIV-1 infection
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: May 2, 2016
Oct 17, 2025 *PED 
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: May 2, 2016
Feb 15, 2033 *PEDU-1259: Prophylaxis of HIV-1 infection
U-1663: Treatment of HIV-1 infection
U-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 26, 2016
Feb 15, 2033 *PEDU-1259: Prophylaxis of HIV-1 infection
U-1663: Treatment of HIV-1 infection
U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 3, 2022I-812: For use in at risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2024ODE-284: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 35kg
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2024ODE-285: In combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 25kg and less than 35kg

GENVOYA (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-HIV Agents, Other == CYP3A inhibitor == Antivirals:Anti-HIV Combinations == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 207561  Prod. No.: 001 RX (150MG;150MG;200MG;EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 1, 2015
Feb 2, 2022U-257: Treatment of HIV infection
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2015
Oct 17, 2025 *PED 
Pat. No. 7176220 DS* DP* [Extended 1011 days (2.8 years)]
4-oxoquinoline compound and use thereof as pharmaceutical agent
Claim Types: Method of use; Compound; Composition
Pat. Sub. Date(s): 001: Dec 1, 2015
Feb 27, 2027 *PEDU-257: Treatment of HIV infection
Pat. No. 7635704 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 1, 2015
Apr 26, 2027 *PEDU-257: Treatment of HIV infection
Pat. No. 8981103 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2015
Apr 26, 2027 *PED 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Dec 1, 2015
Mar 3, 2030 *PEDU-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 9891239 DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Feb 27, 2018
Mar 3, 2030 *PEDU-257: Treatment of HIV infection
Pat. No. 8633219 DP* Combination therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2015
Oct 30, 2030 *PEDU-257: Treatment of HIV infection
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Dec 1, 2015
Feb 15, 2033 *PEDU-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 22, 2016
Feb 15, 2033 *PEDU-257: Treatment of HIV infection
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 28, 2018
Apr 6, 2033 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 10, 2021D-173: Dosing recommendation for the use of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fixed dose combination in HIV-1 infected adult patients with end-stage-renal disease who are receiving chronic hemodialysis

ODEFSEY (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208351  Prod. No.: 001 RX (200MG;EQ 25MG BASE;EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2016
Feb 2, 2022U-257: Treatment of HIV infection
Pat. No. 8101629 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 24, 2016
Aug 9, 2022 
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Mar 24, 2016
Apr 11, 2023 
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)]
HIV inhibiting pyrimidines derivatives
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Mar 24, 2016
Apr 21, 2025U-257: Treatment of HIV infection
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Mar 24, 2016
Oct 17, 2025 *PED 
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Mar 24, 2016
Feb 15, 2033 *PEDU-257: Treatment of HIV infection
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 19, 2016
Feb 15, 2033 *PEDU-257: Treatment of HIV infection

SYMTUZA (TABLET) (ORAL) COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-HIV Agents, Other == CYP3A inhibitor == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations == HIV protease inhibitor == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: JANSSEN PRODS      NDA No.: 210455  Prod. No.: 001 RX (150MG;800MG;200MG;EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 15, 2018
Feb 2, 2022U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2765: Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 15, 2018
Feb 16, 2024 
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 15, 2018
Apr 17, 2025 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Aug 15, 2018
Dec 26, 2026 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Aug 15, 2018
Sep 3, 2029U-2353: Tx of HIV-1 infection using a composition containing a PK enhancer that inhibits cytochrome P450 monooxygenates in adults who have no prior antiretroviral tx history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2364: Treatment of HIV-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase in adults who have no prior antiretroviral treatment history
U-2365: Treatment of HIV-1 infection using a composition containing a pharmacokinetic enhancer that inibits cytochrome P450 monooxygenase in adults who are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2766: Tx of HIV1 infection using a composition containing a pK enhancer that inhibits CY P450 monoxygenase in adults & pediatric patients at least 40kg having no prior ARV tx history or are virologically suppressed on a stable ARV regimen for at least 6 mo
U-2767: Treatment of HIV-1 infection using a composition containing a pk enhancer that inhibits CY P450 monoxygenase in adults and pediatric patients weighing at least 40kg who have no prior ARV treatment history
U-2768: Treatment of HIV-1 infection using a composition containing a pK enhancer that inhibits CY P450 monoxygenase in adults and pediatric patients weighing at least 40kg who are virologically suppressed on a stable ARV regimen for at least 6 months
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Aug 15, 2018
Aug 15, 2032U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2765: Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 15, 2018
Aug 15, 2032U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2765: Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 5, 2018
Oct 6, 2032 
Pat. No. 10786518 Compositions and methods of treating HIV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 28, 2020
Jul 19, 2038U-2978: Treatment of HIV-1 infection in adult or pediatric patients (>=40 kg) with <50 copies/ml HIV-1 RNA after >= 6 months on prior antiretroviral regimen and no known darunavir or tenofovir resistance-associated substitutions
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJul 17, 2021 

VEMLIDY (TABLET) (ORAL) TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-hepatitis B (HBV) Agents == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208464  Prod. No.: 001 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2016
Feb 2, 2022U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)]
Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Nov 28, 2016
Oct 17, 2025 *PED 
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Nov 28, 2016
Feb 15, 2033 *PEDU-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 28, 2016
Feb 15, 2033 *PEDU-999: Treatment of chronic hepatitis B in adult patients
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 4, 2023M-255: Information added to the labeling to describe study GS-US-320-4018 in virologically suppressed adults w/ chronic Hep B infection who switched from tenofovir disoproxil fumarate to tenofovir alafenamide
Exclusivity Code: M - MiscellaneousAug 22, 2023M-266: Information added to the labeling to describe study GS-US-320-4035 in virologically suppressed adults w/ chronic Hep B infection who switched from tenofovir disoproxil fumarate to tenofovir alfaenamide

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: KERYX BIOPHARMS      NDA No.: 205874  Prod. No.: 001 RX (EQ 210MG IRON)
PatentsExpirationPatented Use
Pat. No. 5753706 DP* Methods for treating renal failure
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Oct 2, 2014
Feb 3, 2022U-1577: Control of serum phosphorous levels
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. 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. 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. 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. 9387191 DP* Ferric citrate dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2016
Jul 21, 2030 
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

SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021936  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH); 002 RX (EQ 0.00125MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7988001 DP* Container provided with a pressure equalization opening
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Feb 4, 2022 *PED 
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Feb 26, 2025 *PED 
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Nov 26, 2025 *PED 
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Apr 10, 2027 *PED 
Pat. No. 9027967 DP* Device for clamping a fluidic component
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015
Oct 1, 2027 *PED 
Pat. No. 7837235 DP* Device for clamping a fluidic component
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015
Sep 13, 2028 *PED 
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015
Apr 16, 2031 *PED 

CAPRELSA (TABLET) (ORAL) VANDETANIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: GENZYME CORP      NDA No.: 022405  Prod. No.: 001 RX (100MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 8642608 Quinazoline derivatives as VEGF inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 5, 2018
Feb 6, 2022U-1490: For use in patients having symptomatic or progressive medullary thyroid cancer, with unresectable locally advanced or metastatic disease
Pat. No. RE42353 DS* DP* [Extended 1738 days (4.8 years)]
Quinazoline derivatives and pharmaceutical compositions containing them
Claim Types: Compound; Process; Composit
Pat. Sub. Date(s): All strengths: Jun 3, 2011
Jun 27, 2022 
Pat. No. 8067427 DP* Pharmaceutical compositions comprising ZD6474
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2011; 002: None
Aug 8, 2028 

SELZENTRY (TABLET) (ORAL) MARAVIROC [GENERIC AB]
Drug Classes: Antivirals:Anti-HIV Agents, Other == CCR5 co-receptor antagonist
NDA Applicant: VIIV HLTHCARE      NDA No.: 022128  Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (25MG); 004 RX (75MG)
PatentsExpirationPatented Use
Pat. No. 6667314 DS* DP* [Extended 73 days (0.2 years)]
Tropane derivatives useful in therapy
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 23, 2016; 004: Nov 23, 2016
Feb 6, 2022 *PEDU-824: Method of treating patients infected with CCR5-tropic HIV-1
Pat. No. 7368460 Tropane derivatives useful in therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 23, 2016; 004: Nov 23, 2016
May 25, 2023 *PEDU-824: Method of treating patients infected with CCR5-tropic HIV-1

SELZENTRY (SOLUTION) (ORAL) MARAVIROC
Drug Classes: Antivirals:Anti-HIV Agents, Other == CCR5 co-receptor antagonist
NDA Applicant: VIIV HLTHCARE      NDA No.: 208984  Prod. No.: 001 RX (20MG/ML)
PatentsExpirationPatented Use
Pat. No. 6667314 DS* DP* [Extended 73 days (0.2 years)]
Tropane derivatives useful in therapy
Claim Types: Compound; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Nov 23, 2016
Feb 6, 2022 *PEDU-824: Method of treating patients infected with CCR5-tropic HIV-1
Pat. No. 7368460 Tropane derivatives useful in therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 23, 2016
May 25, 2023 *PEDU-824: Method of treating patients infected with CCR5-tropic HIV-1
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationApr 30, 2024 PED 

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.: 021929  Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH); 002 RX (0.16MG/INH;0.0045MG/INH)
PatentsExpirationPatented Use
Pat. No. 7967011 DP* Inhalation device
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Feb 11, 2022 *PED 
Pat. No. 7759328 DP* Composition for inhalation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8143239 DP* Composition for inhalation
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2012; 002: None
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8575137 DP* Composition for inhalation
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): All strengths: Dec 4, 2013
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 10166247 DP* Composition for inhalation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jan 7, 2019
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 11311558 DP* Composition for inhalation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 20, 2022
Jul 29, 2023 *PED 
Pat. No. 8875699 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 12, 2014
May 10, 2025 *PED 
Pat. No. 7587988 DP* Inhaler device counter
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Oct 10, 2026 *PED 
Pat. No. 8387615 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 4, 2013; 002: None
Sep 26, 2027 *PED 
Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 9, 2013
Apr 16, 2029 *PED 
Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Jan 29, 2014
Oct 7, 2029 *PED 

KYNMOBI (FILM) (SUBLINGUAL) APOMORPHINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Dopamine Agonists == dopaminergic agonist
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 210875  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (25MG); 005 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 14, 2022 
Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 14, 2022 
Pat. No. 10888499 DP* Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jan 14, 2021
Feb 14, 2022 
Pat. No. 11077068 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Aug 5, 2021
Feb 14, 2022 
Pat. No. 8663687 DP* Film compositions for delivery of actives
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 2, 2023 
Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Feb 20, 2024 
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Apr 3, 2024 
Pat. No. 10821074 DP* Sublingual and buccal film compositions
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 12, 2020
Aug 7, 2029 
Pat. No. 9044475 DP* Sublingual apomorphine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030 
Pat. No. 9283219 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9326981 Sublingual apomorphine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9669019 DP* Sublingual apomorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 9669021 Sublingual apomorphine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10420763 DP* Sublingual apomorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Jun 11, 2030U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 8414922 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 8846074 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 11419769 DP* Sublingual films
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 6, 2022
Dec 16, 2031U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10449146 Methods of treating Parkinson's Disease by administration of apomorphine to an oral mucosa
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 4, 2020
Apr 19, 2036U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Pat. No. 10959943 Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 2, 2021
Apr 19, 2036U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 21, 2023 

SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: INDIVIOR INC      NDA No.: 022410  Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
PatentsExpirationPatented Use
Pat. No. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 3, 2018
Feb 14, 2022 
Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 3, 2018
Feb 14, 2022 
Pat. No. 10285910 DP* Sublingual and buccal film compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 7, 2019
Oct 11, 2022 
Pat. No. 8017150 DP* Polyethylene oxide-based films and drug delivery systems made therefrom
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 4, 2011; 002: None; 003: None; 004: None
Feb 13, 2023 
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 3, 2024U-1464: Treatment of opioid dependence/sublingual or buccal application
Pat. No. 9687454 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 14, 2017
Aug 7, 2029U-1464: Treatment of opioid dependence/sublingual or buccal application
Pat. No. 11135216 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Aug 7, 2029U-3111: Treating opioid use disorder
Pat. No. 8475832 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None
Mar 26, 2030U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence

LEVOXYL (TABLET) (ORAL) LEVOTHYROXINE SODIUM [Has competitive generic]
Drug Classes: Hormonal Agents, Stimulant/Replacement/ Modifying (Thyroid) == L-thyroxine (T4)
NDA Applicant: KING PHARMS      NDA No.: 021301  Prod. No.: 001 RX (0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 002 RX (0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 003 RX (0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 004 RX (0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 005 RX (0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 006 RX (0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 007 RX (0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 008 RX (0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 009 RX (0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 010 RX (0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 011 RX (0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium) NDA No.: 021301  Prod. No.: 012 DISC (0.3MG**)
PatentsExpirationPatented Use
Pat. No. 6555581 Levothyroxine compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 15, 2022 
Pat. No. 7067148 DP* Stabilized pharmaceutical and thyroid hormone compositions and method of preparation
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Feb 15, 2022 
Pat. No. 7101569 Methods of administering levothyroxine pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 2, 2023U-759: Method of use of administering levothyroxine

PREVACID IV (INJECTABLE) (INTRAVENOUS) LANSOPRAZOLE
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other
NDA Applicant: TAKEDA PHARMS NA      NDA No.: 021566  Prod. No.: 001 DISC (30MG/VIAL**)
PatentsExpirationPatented Use
Pat. No. 7396841 DP* Injections
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Feb 17, 2022 *PEDU-947: When patients are unable to take the oral formulations, PREVACID IV, for injection is indicated as an alternative for the short-term treatment (up to 7 days) of all grades of erosive esophagitis

METROGEL (GEL) (TOPICAL) METRONIDAZOLE [GENERIC AB]
Drug Classes: Antibacterials:Antibacterials, Other == nitroimidazole antimicrobial
NDA Applicant: GALDERMA LABS LP      NDA No.: 021789  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6881726 DP* Aqueous compositions containing metronidazole
Claim Types: Formulation; Drug in a container; Process; Product-by-process; Method of use
Pat. Sub. Date(s): 001: None
Feb 21, 2022U-743: Once a day topical treatment of the inflammatory lesions of rosacea
Pat. No. 7348317 DP* Aqueous compositions containing metronidazole
Claim Types: Method of use; Kit; Formulation; Process
Pat. Sub. Date(s): 001: None
Feb 21, 2022U-743: Once a day topical treatment of the inflammatory lesions of rosacea

OCALIVA (TABLET) (ORAL) OBETICHOLIC ACID
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == farnesoid X receptor (FXR) agonist
NDA Applicant: INTERCEPT PHARMS INC      NDA No.: 207999  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 8058267 Steroids as agonists for FXR
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 22, 2016
Feb 21, 2022U-1854: Treatment of primary biliary cholangitis (PBC)
Pat. No. 8377916 Steroids as agonists for FXR
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 22, 2016
Feb 21, 2022U-1854: Treatment of primary biliary cholangitis (PBC)
Pat. No. 7138390 DS* DP* Steroids as agonists for FXR
Claim Types: Compound; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 22, 2016
Nov 16, 2022 
Pat. No. RE48286 DS* DP* [Extended 5 years]
Steroids as agonists for FXR
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 28, 2020
Feb 21, 2027 
Pat. No. 9238673 DP* Preparation and uses of obeticholic acid
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Jun 22, 2016
Jun 17, 2033 
Pat. No. 10174073 DS* Preparation and uses of obeticholic acid
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Jan 15, 2019
Jun 17, 2033 
Pat. No. 10047117 Preparation and uses of obeticholic acid
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 14, 2018
Sep 6, 2033U-1854: Treatment of primary biliary cholangitis (PBC)
Pat. No. 10052337 DP* Compositions of obeticholic acid and methods of use
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Nov 8, 2018
Apr 26, 2036 
Pat. No. 10751349 DP* Compositions of obeticholic acid and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 28, 2020
Apr 26, 2036 
Pat. No. 10758549 Compositions of obeticholic acid and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 10, 2020
Apr 26, 2036U-2945: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-119: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca, or as monotherapy in adults unable to tolerate udca

GENOSYL (GAS) (INHALATION) NITRIC OXIDE [Has competitive generic]
NDA Applicant: VERO BIOTECH      NDA No.: 202860  Prod. No.: 001 RX (800PPM)
PatentsExpirationPatented Use
Pat. No. 6758214 DP* Simple nitric oxide generator for ambulatory and/or bedside inhaled NO treatment
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 10, 2020
Feb 23, 2022 
Pat. No. 8226916 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Method of administration; Process
Pat. Sub. Date(s): 001: Jan 15, 2021
Aug 18, 2025U-3037: A method of delivering nitric oxide to a patient
Pat. No. 8609028 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2021
Aug 18, 2025U-3037: A method of delivering nitric oxide to a patient
Pat. No. 8821801 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Claim Types: Device; Part of a device
Pat. Sub. Date(s): 001: Jan 15, 2021
Aug 18, 2025 
Pat. No. 9522249 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2021
Aug 18, 2025 
Pat. No. 9956373 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2021
Aug 18, 2025U-3037: A method of delivering nitric oxide to a patient
Pat. No. 10124142 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2021
Aug 18, 2025U-3037: A method of delivering nitric oxide to a patient
Pat. No. 11291793 DP* Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Device
Pat. Sub. Date(s): 001: May 5, 2022
Aug 18, 2025 
Pat. No. 11383059 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Process; Method of administration
Pat. Sub. Date(s): 001: Aug 11, 2022
Aug 18, 2025U-3037: A method of delivering nitric oxide to a patient
Pat. No. 10814092 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2021
Oct 17, 2025U-3037: A method of delivering nitric oxide to a patient
Pat. No. 8057742 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2021
Jan 18, 2026U-3037: A method of delivering nitric oxide to a patient
Pat. No. 7618594 DP* Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 10, 2020
Oct 17, 2026 
Pat. No. 7947227 Kit for the conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Claim Types: Kit; Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2021
Oct 17, 2026U-3037: A method of delivering nitric oxide to a patient
Pat. No. 7560076 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 10, 2020
Apr 21, 2027 
Pat. No. 9701538 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Claim Types: Part of a dosage form
Pat. Sub. Date(s): 001: Jan 15, 2021
Jan 28, 2029 
Pat. No. 8944049 DP* Systems and devices for generating nitric oxide
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2021
Aug 13, 2029 
Pat. No. 9604028 Systems and devices for generating nitric oxide
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 5, 2020
Aug 13, 2029U-2793: A method for delivering nitric oxide to a patient with pulmonary hypertension or hypoxia
Pat. No. 10926054 DP* Systems and devices for generating nitric oxide
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 9, 2021
Aug 13, 2029 
Pat. No. 11103669 DP* Nitric oxide therapies
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 23, 2021
Jun 21, 2030 
Pat. No. 8607785 DP* Systems and devices for generating nitric oxide
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2021
Jul 14, 2030 
Pat. No. 10737051 DP* Nitrogen dioxide storage device
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 21, 2020
Oct 20, 2035 
Pat. No. 10213572 DP* Nitrogen dioxide storage cassette
Claim Types: Device
Pat. Sub. Date(s): 001: May 5, 2020
Feb 12, 2036 

PEPCID AC (TABLET, CHEWABLE) (ORAL) FAMOTIDINE
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist
NDA Applicant: J AND J CONSUMER INC      NDA No.: 020801  Prod. No.: 002 OTC (20MG)
PatentsExpirationPatented Use
Pat. No. 6814978 DP* Process for preparing a soft tablet
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: None
Feb 26, 2022 *PED 

PEPCID COMPLETE (TABLET, CHEWABLE) (ORAL) CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE [GENERIC OTC]
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist
NDA Applicant: J AND J CONSUMER INC      NDA No.: 020958  Prod. No.: 001 OTC (800MG;10MG;165MG)
PatentsExpirationPatented Use
Pat. No. 6814978 DP* Process for preparing a soft tablet
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
Feb 26, 2022 *PED 

PRISTIQ (TABLET, EXTENDED RELEASE) (ORAL) DESVENLAFAXINE SUCCINATE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: PF PRISM CV      NDA No.: 021992  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 6673838 DS* [Extended 18 days (0 years)]
Succinate salt of O-desmethyl-venlafaxine
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None; 002: None; 003: Feb 2, 2015
Mar 1, 2022U-1364: Maintenance treatment of major depressive disorder (MDD)
U-860: For the approved uses and conditions of use, including depression
Pat. No. 8269040 DS* Derivatives of venlafaxine and methods of preparing and using the same
Claim Types: Compound
Pat. Sub. Date(s): 001: None; 002: None; 003: Feb 2, 2015
Jul 5, 2027 

BEYAZ (TABLET) (ORAL) DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM [GENERIC AB]
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens
NDA Applicant: BAYER HLTHCARE      NDA No.: 022532  Prod. No.: 001 RX (3MG,N/A;0.02MG,N/A;0.451MG,0.451MG)
PatentsExpirationPatented Use
Pat. No. 7163931 Compositions of estrogen-cyclodextrin complexes
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 3, 2022U-1: Prevention of pregnancy
Pat. No. 6441168 DS* [Extended 834 days (2.3 years)]
Stable crystalline salts of 5-methyltetrahydrofolic acid
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Jul 30, 2022 
Pat. No. 8617597 DP* Pharmaceutical composition containing a tetrahydrofolic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 29, 2014
Feb 8, 2030 

SAFYRAL (TABLET) (ORAL) DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM [GENERIC AB]
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens
NDA Applicant: BAYER HLTHCARE      NDA No.: 022574  Prod. No.: 001 RX (3MG,N/A;0.03MG,N/A;0.451MG,0.451MG)
PatentsExpirationPatented Use
Pat. No. 7163931 Compositions of estrogen-cyclodextrin complexes
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 3, 2022U-1: Prevention of pregnancy
Pat. No. 8617597 DP* Pharmaceutical composition containing a tetrahydrofolic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 29, 2014
Feb 8, 2030 

TEKTURNA HCT (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Diuretics, Thiazide
NDA Applicant: NODEN PHARMA      NDA No.: 022107  Prod. No.: 001 DISC (EQ 150MG BASE;12.5MG); 002 DISC (EQ 150MG BASE;25MG); 003 DISC (EQ 300MG BASE;12.5MG); 004 DISC (EQ 300MG BASE;25MG)
PatentsExpirationPatented Use
Pat. No. 9023893 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Mar 3, 2022 
Pat. No. 8618172 DP* Galenical formulations of organic compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jul 13, 2028 

BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 022200  Prod. No.: 001 DISC (2MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Mar 3, 2022 *PED 
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Apr 9, 2023 *PED 
Pat. No. 7563871 DP* Polymer-based sustained release device
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Oct 15, 2024 *PED 
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 17, 2016
Oct 15, 2024 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 29, 2013
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 10, 2013
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Dec 30, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 17, 2017
Apr 4, 2026 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 10, 2013
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2015
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9884092 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 6, 2018
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 17, 2017
Dec 20, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 17, 2017
Sep 21, 2028 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 15, 2022M-240: Information added to labeling regarding a randomized, placebo-controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with Type 2 diabetes mellites
Exclusivity Code: NPP - New patient populationJan 22, 2025 PED 

BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 209210  Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
PatentsExpirationPatented Use
Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Nov 3, 2017
Mar 3, 2022 *PED 
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Nov 3, 2017
Apr 9, 2023 *PED 
Pat. No. 7563871 DP* Polymer-based sustained release device
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 15, 2024 *PED 
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 15, 2024 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 13, 2025 *PEDU-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Dec 30, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2019
Apr 4, 2026 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 3, 2017
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9884092 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 6, 2018
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2019
Dec 20, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 21, 2019
Sep 21, 2028 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8895033 DP* Sustained release formulations using non-aqueous carriers
Claim Types: Formulation; Method of use; Kit
Pat. Sub. Date(s): 001: Nov 3, 2017
Apr 4, 2031 *PEDU-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin
U-2601: Stimulating insulin release in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise
U-2602: Delaying gastric emptying in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 15, 2022M-240: Information added to labeling regarding a randomized, placebo-controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with Type 2 diabetes mellites
Exclusivity Code: NPP - New patient populationJan 22, 2025 PED 

BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 022200  Prod. No.: 002 DISC (2MG)
PatentsExpirationPatented Use
Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Mar 28, 2014
Mar 3, 2022 *PED 
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Mar 28, 2014
Apr 9, 2023 *PED 
Pat. No. 7563871 DP* Polymer-based sustained release device
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 15, 2024 *PED 
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 17, 2016
Oct 15, 2024 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Oct 13, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Dec 30, 2025 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 4, 2026 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 28, 2014
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 6, 2015
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 9884092 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 6, 2018
Feb 18, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin
U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies
U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml
U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise
U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication
U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Dec 20, 2027 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8758292 DP* Administering apparatus with functional drive element
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
May 12, 2028 *PED 
Pat. No. 8216180 DP* Administering apparatus with functional drive element
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 28, 2014
Jul 12, 2028 *PED 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Sep 21, 2028 *PEDU-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin
Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 28, 2014
Sep 25, 2028 *PED 
Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule
Claim Types: Device; Process
Pat. Sub. Date(s): 002: Nov 15, 2017
Sep 25, 2028 *PED 
Pat. No. 8827963 DP* Administering device with holding mechanism
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Aug 4, 2029 *PED 
Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Nov 19, 2029 *PED 
Pat. No. 8998876 DP* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Jul 7, 2030 *PED 
Pat. No. 8721615 DP* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Jul 18, 2030 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 15, 2022M-240: Information added to labeling regarding a randomized, placebo-controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with Type 2 diabetes mellites
Exclusivity Code: NPP - New patient populationJan 22, 2025 PED 

FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
Drug Classes: Antineoplastics:Treatment Adjuncts == Antineoplastics:Antineoplastics, Other == folate analog
NDA Applicant: ACROTECH      NDA No.: 020140  Prod. No.: 001 RX (EQ 50MG BASE/VIAL) NDA No.: 020140  Prod. No.: 002 DISC (EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)**); 003 DISC (EQ 250MG BASE/25ML (EQ 10MG BASE/ML)**)
PatentsExpirationPatented Use
Pat. No. 6500829 DS* DP* [Extended 797 days (2.2 years)]
Substantially pure diastereoisomers of tetrahydrofolate derivatives
Claim Types: Formulation
Pat. Sub. Date(s): 001: None; 002: May 9, 2011; 003: May 9, 2011
Mar 7, 2022 

LEQVIO (SOLUTION) (SUBCUTANEOUS) INCLISIRAN SODIUM
NDA Applicant: NOVARTIS      NDA No.: 214012  Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9074213 DS* Compositions and methods for inhibiting expression of a target gene
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Mar 9, 2022U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 8546143 DS* Compositions and methods for inhibiting expression of a target gene
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Apr 23, 2022U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 10590418 Methods and compositions for RNAi mediated inhibition of gene expression in mammals
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Jul 19, 2022U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 8232383 DS* DP* RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA)
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 18, 2022
Feb 20, 2023 
Pat. No. 10266825 Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Nov 4, 2023U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 11078485 DS* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Nov 4, 2023U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Jan 1, 2024U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 9708615 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Mar 8, 2024 
Pat. No. 10273477 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Mar 8, 2024 
Pat. No. 10669544 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Mar 8, 2024 
Pat. No. 8809292 DS* DP* Compositions and methods for inhibiting expression of the PCSK9 gene
Claim Types: Compound; Composition; Cell; Vector; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
May 10, 2027U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 8222222 Compositions and methods for inhibiting expression of the PCSK9 gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 29, 2027U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Aug 24, 2028U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 4, 2028U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 9370582 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 4, 2028U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 10806791 DS* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 4, 2028 
Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Dec 12, 2029U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 10125369 DS* DP* PCSK9 iRNA compositions and methods of use thereof
Claim Types: Compound; Composition; Cell; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Aug 18, 2034U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
Pat. No. 10851377 Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Aug 25, 2036U-3272: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HEFH) or clinical atherosclerotic cardiovascular disease (ASCVD), by inhibiting expression of the PCSK9 gene
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 22, 2026 

VIMPAT (TABLET) (ORAL) LACOSAMIDE [GENERIC AB]
Drug Classes: Anticonvulsants:Sodium Channel Agents
NDA Applicant: UCB INC      NDA No.: 022253  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG); 004 RX (200MG)
PatentsExpirationPatented Use
Pat. No. RE38551 DS* DP* [Extended 5 years]
Anticonvulsant enantiomeric amino acid derivatives
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: None
Mar 17, 2022U-1567: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older
U-2140: Method of treating partial onset seizures in patients 4 years of age and older
U-2989: Method of use as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older
U-2990: Method of use for treatment of partial-onset seizures in patients 4 years of age and older
U-2999: Method of use of treating, as an initial loading dose for monotherapy or adjunctive therapy in partial onset seizure patients with epilepsy aged 17 years or older
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 16, 2023I-878: Addition of a new indication for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older
Exclusivity Code: NPP - New patient populationOct 14, 2024 

VIMPAT (SOLUTION) (INTRAVENOUS) LACOSAMIDE [GENERIC AP]
Drug Classes: Anticonvulsants:Sodium Channel Agents
NDA Applicant: UCB INC      NDA No.: 022254  Prod. No.: 001 RX (200MG/20ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. RE38551 DS* DP* [Extended 5 years]
Anticonvulsant enantiomeric amino acid derivatives
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None
Mar 17, 2022U-1565: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older when oral administration is temporarily not feasible
U-1568: Method of treating, as monotherapy or adjunctive therapy, partial-onset seizures in a patient with epilepsy aged 17 years and older when oral administration is temporarily not feasible
U-2989: Method of use as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older
U-2990: Method of use for treatment of partial-onset seizures in patients 4 years of age and older
U-2999: Method of use of treating, as an initial loading dose for monotherapy or adjunctive therapy in partial onset seizure patients with epilepsy aged 17 years or older
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 16, 2023I-878: Addition of a new indication for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older
Exclusivity Code: NPP - New patient populationNov 16, 2023 
Exclusivity Code: NPP - New patient populationOct 14, 2024 

VIMPAT (SOLUTION) (ORAL) LACOSAMIDE [GENERIC AA]
Drug Classes: Anticonvulsants:Sodium Channel Agents
NDA Applicant: UCB INC      NDA No.: 022255  Prod. No.: 001 RX (10MG/ML)
PatentsExpirationPatented Use
Pat. No. RE38551 DS* DP* [Extended 5 years]
Anticonvulsant enantiomeric amino acid derivatives
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None
Mar 17, 2022U-1567: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older
U-2140: Method of treating partial onset seizures in patients 4 years of age and older
U-2989: Method of use as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older
U-2990: Method of use for treatment of partial-onset seizures in patients 4 years of age and older
U-2999: Method of use of treating, as an initial loading dose for monotherapy or adjunctive therapy in partial onset seizure patients with epilepsy aged 17 years or older
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNov 16, 2023I-878: Addition of a new indication for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older
Exclusivity Code: NPP - New patient populationOct 14, 2024 

VAZALORE (CAPSULE) (ORAL) ASPIRIN
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents == anti-platelet agent == nonsteroidal anti-inflammatory drug
NDA Applicant: PLX PHARMA      NDA No.: 203697  Prod. No.: 001 OTC (325MG)
PatentsExpirationPatented Use
Pat. No. 8865187 DP* Compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 10, 2014
Mar 23, 2022 
Pat. No. 9101637 Methods of treating inflammation with compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Sep 9, 2015
Mar 23, 2022U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease
Pat. No. 9216150 DP* pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 14, 2016
Sep 29, 2032 
Pat. No. 9226892 pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 14, 2016
Sep 29, 2032U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-1733: Treatment/prevention of cardiovascular disease

SPIRIVA (POWDER) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021395  Prod. No.: 001 RX (EQ 0.018MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6777423 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Mar 24, 2022 *PED 
Pat. No. 6908928 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof,and pharmaceutical compositions
Claim Types: Composition; Product-by-process; Method of use
Pat. Sub. Date(s): 001: None
Mar 24, 2022 *PEDU-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
U-762: Treatment of chronic obstructive pulmonary disease
Pat. No. 7309707 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Mar 24, 2022 *PED 
Pat. No. 7642268 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: None
Mar 24, 2022 *PED 
Pat. No. RE38912 DP* Process for preparing powder formulations
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Apr 11, 2022 *PED 
Pat. No. 7070800 DP* Inhalable powder containing tiotropium
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Jul 22, 2022 *PEDU-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Pat. No. 8022082 DP* Method for the administration of an anticholinergic by inhalation
Claim Types: Method of administration; Kit
Pat. Sub. Date(s): 001: Oct 24, 2011
Jul 19, 2026 *PEDU-1186: Administration of an inhalable powder comprising tiotropium via device
Pat. No. 7694676 DP* Dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 13, 2011
Sep 12, 2027 *PED 
Pat. No. 9010323 DP* Inhaler and sieve for an inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 20, 2017
Apr 19, 2030 

CLARINEX D 24 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == alpha adrenergic agonist
NDA Applicant: ORGANON      NDA No.: 021605  Prod. No.: 001 DISC (5MG;240MG**)
PatentsExpirationPatented Use
Pat. No. 6979463 DP* Stable extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Mar 28, 2022 
Pat. No. 7820199 DP* Stable extended release oral dosage composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 23, 2010
Sep 28, 2022 *PED 

TRULANCE (TABLET) (ORAL) PLECANATIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: SALIX      NDA No.: 208745  Prod. No.: 001 RX (3MG)
PatentsExpirationPatented Use
Pat. No. 8637451 Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 14, 2017
Mar 28, 2022U-1964: Elevation of intracellular cGMP resulting in increased intestinal fluid and accelerated transit
Pat. No. 7799897 DS* Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Feb 14, 2017
Jun 9, 2022 
Pat. No. 7041786 DS* [Extended 1772 days (4.9 years)]
Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: Feb 14, 2017
Jan 30, 2028 
Pat. No. 9610321 Formulations of guanylate cyclase C agonists and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 1, 2017
Sep 15, 2031U-1999: Chronic idiopathic constipation
U-2230: Irritable bowel syndrome with constipation
Pat. No. 9919024 Formulations of guanylate cyclase C agonists and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 10, 2018
Sep 15, 2031U-1999: Chronic idiopathic constipation
U-2230: Irritable bowel syndrome with constipation
Pat. No. 9925231 DP* Formulations of guanylate cyclase C agonists and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 10, 2018
Sep 15, 2031 
Pat. No. 11319346 DP* Ultra-pure agonists of guanylate cyclase C, method of making and using same
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: May 11, 2022
Mar 1, 2032 
Pat. No. 9616097 DP* Formulations of guanylate cyclase C agonists and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 1, 2017
Aug 20, 2032 
Pat. No. 10011637 DS* Ultra-pure agonists of guanylate cyclase C, method of making and using same
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jul 19, 2018
Jun 5, 2034 
Pat. No. 11142549 DP* Ultra-pure agonists of guanylate cyclase C, method of making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 25, 2021
Jun 5, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 19, 2022 

ARESTIN (POWDER, EXTENDED RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: Antibacterials:Tetracyclines == Dental and Oral Agents
NDA Applicant: ORAPHARMA      NDA No.: 050781  Prod. No.: 001 RX (EQ 1MG BASE)
PatentsExpirationPatented Use
Pat. No. 6682348 DP* Dispensing apparatus and cartridge
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 24, 2012
Mar 29, 2022 
Pat. No. 7699609 DP* Dispensing apparatus and cartridge with deformable tip
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 26, 2015
Mar 29, 2022 

NOXAFIL (SUSPENSION) (ORAL) POSACONAZOLE
Drug Classes: Antifungals == azole antifungal
NDA Applicant: SCHERING      NDA No.: 022003  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 8263600 DP* Antifungal composition with enhanced bioavailability
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 1, 2022 

ORACEA (CAPSULE) (ORAL) DOXYCYCLINE
Drug Classes: Antibacterials:Tetracyclines == Dental and Oral Agents
NDA Applicant: GALDERMA LABS LP      NDA No.: 050805  Prod. No.: 001 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7211267 Methods of treating acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 5, 2022U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 7232572 Methods of treating rosacea
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 5, 2022U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8603506 Methods of treating acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 5, 2022U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 9241946 Methods of treating acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 3, 2016
Apr 5, 2022U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 10058564 Methods of treating acne
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 25, 2018
Apr 5, 2022U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8394405 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Mar 25, 2013
Apr 7, 2024U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8394406 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Mar 25, 2013
Apr 7, 2024U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8470364 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 26, 2013
Apr 7, 2024U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8709478 Once daily formulations of tetracyclines
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 30, 2014
Apr 7, 2024U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 8206740 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
Dec 24, 2025U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea
Pat. No. 7749532 DP* Once daily formulations of tetracyclines
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: None
Dec 19, 2027U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea

ZOLADEX (IMPLANT) (IMPLANTATION) GOSERELIN ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TERSERA      NDA No.: 019726  Prod. No.: 001 RX (EQ 3.6MG BASE)
PatentsExpirationPatented Use
Pat. No. 7220247 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 9, 2022 
Pat. No. 7118552 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 13, 2022 

ZOLADEX (IMPLANT) (IMPLANTATION) GOSERELIN ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TERSERA      NDA No.: 020578  Prod. No.: 001 RX (EQ 10.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 7220247 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 9, 2022 
Pat. No. 7118552 DP* Automatically operable safety shield system for syringes
Claim Types: Device
Pat. Sub. Date(s): 001: None
Apr 13, 2022 

LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON [GENERIC AP]
Drug Classes: adenosine receptor agonist == pharmacologic stress agent
NDA Applicant: ASTELLAS      NDA No.: 022161  Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
PatentsExpirationPatented Use
Pat. No. 6403567 DS* DP* [Extended 1024 days (2.8 years)]
N-pyrazole A2A adenosine receptor agonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None
Apr 10, 2022U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart
Pat. No. RE47301 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Claim Types: Product-by-process; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 2, 2019
Feb 2, 2027 
Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 8, 2012
Feb 2, 2027 

CONZIP (CAPSULE, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CIPHER PHARMS INC      NDA No.: 022370  Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 7858118 DP* Extended release composition containing Tramadol
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Apr 11, 2022U-1104: Use of tramadol for the management of moderate to moderately severe chronic pain

TEFLARO (POWDER) (INTRAVENOUS) CEFTAROLINE FOSAMIL
Drug Classes: Antibacterials:Beta-lactam, Cephalosporins == cephalosporin antibacterial
NDA Applicant: ALLERGAN      NDA No.: 200327  Prod. No.: 001 RX (400MG/VIAL); 002 RX (600MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6417175 DS* DP* [Extended 1211 days (3.3 years)]
Phosphonocephem derivatives, process for the preparation of the same, and use thereof
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Apr 11, 2022U-1676: Methods for treating bacterial infections
Pat. No. 9629861 DP* Compositions and methods for treating bacterial infections using ceftaroline
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 17, 2017
Sep 21, 2030 
Pat. No. 8247400 DP* Cephem compounds useful for the treatment of bacterial infections
Claim Types: Compound; Composition; Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Feb 10, 2031U-282: Method of treating bacterial infections
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationSep 13, 2022 

WELCHOL (BAR, CHEWABLE) (ORAL) COLESEVELAM HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Cardiovascular Agents:Dyslipidemics, Other == bile acid sequestrant
NDA Applicant: COSETTE      NDA No.: 210895  Prod. No.: 001 DISC (3.75GM)
PatentsExpirationPatented Use
Pat. No. 7229613 Method for lowering serum glucose
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
Apr 17, 2022U-2516: A method for reducing serum glucose levels in adults with Type 2 diabetes mellitus

COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == Antimigraine Agents:Antimigraine Agents, Other == Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN      NDA No.: 021398  Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
PatentsExpirationPatented Use
Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP
Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 2, 2012
Apr 19, 2022U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Mar 27, 2013
Apr 19, 2022U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma
Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 7, 2014
Apr 19, 2022U-1524: Reduction of elevated intraocular pressure
Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2016
Apr 19, 2022U-1524: Reduction of elevated intraocular pressure
Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 12, 2017
Apr 19, 2022U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 7, 2018
Apr 19, 2022U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 7, 2018
Apr 19, 2022U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid

IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: THE MEDICINES CO      NDA No.: 021338  Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
PatentsExpirationPatented Use
Pat. No. 6881208 Method and device for transdermal electrotransport delivery of fentanyl and sufentanil
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 1, 2024 
Pat. No. 8301238 DP* Two-part electrotransport device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Sep 30, 2031 
Pat. No. 9364656 Method of storing an electrotransport drug delivery device
Claim Types: Process
Pat. Sub. Date(s): 001: Jun 21, 2016
Sep 30, 2031U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9731121 DP* Switch validation circuit and method
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 12, 2017
Oct 17, 2031 
Pat. No. 8781571 DP* Switch validation circuit and method
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 001: May 28, 2015
Mar 31, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428708 Self-test for analgesic product
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: None
May 21, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428709 DP* Current control for electrotransport drug delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: May 28, 2015
Jun 11, 2032U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9095706 DP* Self-test for analgesic product
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 3, 2033 

CERDELGA (CAPSULE) (ORAL) ELIGLUSTAT TARTRATE [GENERIC AB]
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == glucosylceramide synthase inhibitor
NDA Applicant: GENZYME CORP      NDA No.: 205494  Prod. No.: 001 RX (EQ 84MG BASE)
PatentsExpirationPatented Use
Pat. No. 6916802 DS* Amino ceramide-like compounds and therapeutic methods of use
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Sep 15, 2014
Apr 29, 2022U-1571: Treatment of Gaucher disease type 1
Pat. No. 7253185 DP* Amino ceramide-like compounds and therapeutic methods of use
Claim Types: Composition
Pat. Sub. Date(s): 001: May 10, 2018
Apr 29, 2022 
Pat. No. 7615573 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 21, 2014
Apr 29, 2022U-1571: Treatment of Gaucher disease type 1
Pat. No. 7196205 DS* [Extended 1519 days (4.2 years)]
Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
Claim Types: Compound
Pat. Sub. Date(s): 001: Oct 21, 2014
Jun 26, 2026 
Pat. No. 10888547 Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 21, 2021
Jan 31, 2031U-3042: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 poor metabolizers with 84 mg once daily of eliglustat (equivalent to 100 mg of eliglustat tartrate)
U-3043: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive or intermediate metabolizers with 84 mg twice per day of eliglustat (equivalent to 100 mg of eliglustat tartrate twice per day)
Pat. No. 10888544 Methods for treating Gaucher disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 21, 2021
Dec 13, 2038U-3040: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive metabolizers with mild hepatic impairment and are concurrently taking a strong or moderate cyp3a inhibitor
U-3041: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive metabolizers with moderate to severe renal impairment
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 19, 2021ODE-73: Long-term treatment of adult patients with gaucher disease type 1 who are cyp2d6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

LYNPARZA (CAPSULE) (ORAL) OLAPARIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 206162  Prod. No.: 001 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 7151102 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Apr 29, 2022 
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Mar 12, 2024U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor
Pat. No. 7449464 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Oct 11, 2024 
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Oct 11, 2024 
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Aug 12, 2027U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor
Pat. No. 8247416 DS* Phthalazinone derivative
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 24, 2028 
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): 001: Jan 15, 2015
Aug 4, 2031U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2021ODE-83: Use of as monotherapy for patients with deleterious or suspected deleterious germline brca mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy

LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 7151102 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Apr 29, 2022 
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Mar 12, 2024U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
Pat. No. 9169235 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 18, 2020
Mar 12, 2024U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
Pat. No. 9566276 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 22, 2020
Mar 12, 2024U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
Pat. No. 7449464 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Oct 11, 2024 
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Oct 11, 2024 
Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 18, 2020
Aug 12, 2027U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Aug 12, 2027U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
Pat. No. 8475842 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-p- hthalazin-1-one
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 15, 2017
Dec 31, 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 15, 2017
Aug 4, 2031U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy
U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation
U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability
U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone
U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 19, 2021I-776: Firstline maintenance tx in pts w/ deleterious or suspected deleterious germline, somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal CA who are in complete or partial response to firstline platinum-based chemotherapy
Exclusivity Code: I - New IndicationDec 27, 2022I-818: Maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
Exclusivity Code: I - New IndicationMay 8, 2023I-831: W/bevacizumab for maintenance tx of adults w/adv. epithelial ovarian, fallopian tube or primary peritoneal ca in complete or partial response to first-line platinum-based chemo & ca associated w/ homologous recombination deficiency positive status
Exclusivity Code: I - New IndicationMay 19, 2023I-832: Tx of adult pts with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone
Exclusivity Code: I - New IndicationMar 11, 2025I-885: For the adjuvant treatment of adult patients with deleterious or suspected deleterious GBRCA mutated HER2-negative high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityAug 17, 2024ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityAug 17, 2024ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2025ODE-226: Maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivityDec 27, 2026ODE-283: Maintenance tx of adults w/ deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose dz has not progressed on >=16wks of 1st line platinum based chemo regimen. select pts for therapy based on approved companion diagnostic
Exclusivity Code: ODE - Orphan drug exclusivityMay 8, 2027ODE-306: W/ bevacizumab for maint tx of adults w/ adv epithelial ovarian, fallopian tube, or primary peritoneal CA in complete or partial response to 1st line pt based chemo & whose CA is assoc w/ homologous recomb def + status defined by genomic instability
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2021ODE-83: Use of as monotherapy for patients with deleterious or suspected deleterious germline brca mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy

NEXTERONE (INJECTABLE) (INJECTION) AMIODARONE HYDROCHLORIDE
Drug Classes: Cardiovascular Agents:Antiarrhythmics
NDA Applicant: BAXTER HLTHCARE      NDA No.: 022325  Prod. No.: 002 RX (150MG/100ML (1.5MG/ML)); 003 RX (360MG/200ML (1.8MG/ML)) NDA No.: 022325  Prod. No.: 001 DISC (50MG/ML**)
PatentsExpirationPatented Use
Pat. No. 6869939 DP* Formulations containing amiodarone and sulfoalkyl ether cyclodextrin
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
May 4, 2022 
Pat. No. 7635773 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Mar 13, 2029 

EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: GW RES LTD      NDA No.: 210365  Prod. No.: 001 RX (100MG/ML)
PatentsExpirationPatented Use
Pat. No. 10195159 DS* Processes and apparatus for extraction of active substances and enriched extracts from natural products
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 26, 2019
May 7, 2022 
Pat. No. 9949937 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Jun 17, 2035U-2421: Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome
Pat. No. 9956183 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Jun 17, 2035U-2422: Use in combination with clobazam for the treatment of seizures in patients with lennox gastaut syndrome who have been previously treated with clobazam
U-2423: Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome who have been previously treated with clobazam
Pat. No. 9956184 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Jun 17, 2035U-2424: Use in combination with clobazam for treatment of seizures in patients with lennox gastaut syndrome
Pat. No. 9956185 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Jun 17, 2035U-2425: Use for the treatment of convulsive seizures in patients with Dravet Syndrome
Pat. No. 9956186 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Jun 17, 2035U-2426: Use for the treatment of convulsive seizures in patients with Lennox Gastaut Syndrome
Pat. No. 10092525 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Jun 17, 2035U-2427: Use for the treatment of drop seizures in patients with Dravet Syndrome
Pat. No. 10111840 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 27, 2018
Jun 17, 2035U-2442: Use for the treatment of atonic seizures in patients with Lennox-Gastaut syndrome
U-2443: Use for the treatment of atonic seizures in patients with Dravet syndrome
Pat. No. 10137095 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2018
Jun 17, 2035U-2454: Use for the treatment of drop seizures in patients with Lennox-Gastaut Syndrome
U-2455: Use in combination with clobazam for treatment of drop seizures in patients with Lennox Gastaut Syndrome
Pat. No. 10603288 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2020
Jun 17, 2035U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome
U-2781: Use for the treatment of seizures in patients with Dravet syndrome
U-2782: Use for reducing convulsive seizure frequency in patients with Lennox Gastaut syndrome
U-2783: Use for reducing convulsive seizure frequency in patients with Dravet syndrome
Pat. No. 10709671 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 30, 2020
Jun 17, 2035U-2862: Use for the treatment of focal seizures in patients with Dravet syndrome
Pat. No. 10709673 DP* Use of cannabinoids in the treatment of epilepsy
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 30, 2020
Jun 17, 2035 
Pat. No. 10709674 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 30, 2020
Jun 17, 2035U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome
U-2781: Use for the treatment of seizures in patients with Dravet syndrome
Pat. No. 10849860 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 18, 2020
Jun 17, 2035U-2427: Use for the treatment of drop seizures in patients with Dravet Syndrome
U-2454: Use for the treatment of drop seizures in patients with Lennox-Gastaut Syndrome
Pat. No. 10966939 DP* Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Apr 30, 2021
Jun 17, 2035U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome
U-2781: Use for the treatment of seizures in patients with Dravet syndrome
Pat. No. 11154516 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 4, 2021
Jun 17, 2035U-3235: Use for the treatment of seizures associated with dravet syndrome
U-3236: Use for the treatment of seizures associated with Lennox-Gastaut syndrome
Pat. No. 11311498 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 20, 2022
Jun 17, 2035U-3375: Use for the treatment of absence seizures in patients with Dravet syndrome
U-3376: Use for the treatment of absence seizures in patients with Lennox-Gastaut syndrome
Pat. No. 11357741 Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 13, 2022
Jun 17, 2035U-2862: Use for the treatment of focal seizures in patients with Dravet syndrome
Pat. No. 10918608 Use of cannabidiol in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 26, 2021
Oct 13, 2035U-3071: Use for the treatment of seizures in patients with tuberous sclerosis complex
U-3072: Use for the treatment of generalized seizures or focal seizures with impairment in patients with tuberous sclerosis complex
U-3073: Use for reducing seizure frequency in patients with tuberous sclerosis complex
Pat. No. 11065209 Use of cannabidiol in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2021
Oct 13, 2035U-3071: Use for the treatment of seizures in patients with tuberous sclerosis complex
Pat. No. 11096905 DS* DP* Use of cannabinoids in the treatment of epilepsy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Sep 16, 2021
Oct 13, 2035U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome
U-2781: Use for the treatment of seizures in patients with Dravet syndrome
Pat. No. 11400055 Use of cannabidiol in the treatment of epilepsy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2022
Oct 13, 2035U-3071: Use for the treatment of seizures in patients with tuberous sclerosis complex
Pat. No. 11207292 DS* Cannabidiol preparations and its uses
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 19, 2022
Apr 26, 2039U-3235: Use for the treatment of seizures associated with dravet syndrome
U-3236: Use for the treatment of seizures associated with Lennox-Gastaut syndrome
U-3277: Use for the treatment of seizures associated with tuberous sclerosis complex
Pat. No. 11160795 Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 4, 2021
Mar 1, 2041U-3233: Use for the treatment of seizures associated with tuberous sclerosis complex in patients taking everolimus
Pat. No. 11406623 Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Aug 31, 2022
Mar 1, 2041U-3233: Use for the treatment of seizures associated with tuberous sclerosis complex in patients taking everolimus
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 28, 2023 
Exclusivity Code: NPP - New patient populationJul 31, 2023 
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2025ODE-216: Indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) in patients 2 years of age and older
Exclusivity Code: ODE - Orphan drug exclusivityJul 31, 2027ODE-326: Treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients between 1 and 2 years of age
Exclusivity Code: ODE - Orphan drug exclusivityJul 31, 2027ODE-332: Treatment of seizures associated with tuberous sclerosis complex (TSC) in patients 1 year of age and older

TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 205777  Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
PatentsExpirationPatented Use
Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2015
May 10, 2022U-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. 9056051 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 30, 2015
May 10, 2022U-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. 9084729 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2015
May 10, 2022U-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. 9161937 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 27, 2015
May 10, 2022U-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. 9168252 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 27, 2015
May 10, 2022U-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. 9283216 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 15, 2016
May 10, 2022U-1819: 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. 9283221 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 15, 2016
May 10, 2022U-1819: 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. 9345701 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 24, 2016
May 10, 2022U-1819: 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. 9511066 Abuse-resistant controlled-release opioid dosage form
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 6, 2016
May 10, 2022U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 30, 2014
Apr 4, 2023 
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 30, 2014
Apr 4, 2023 
Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 1, 2017
Apr 4, 2023U-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. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Apr 4, 2023U-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. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025 

TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 205777  Prod. No.: 003 DISC (20MG;40MG)
PatentsExpirationPatented Use
Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Mar 3, 2015
May 10, 2022U-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. 9056051 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Jun 30, 2015
May 10, 2022U-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. 9084729 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Jul 22, 2015
May 10, 2022U-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. 9161937 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 27, 2015
May 10, 2022U-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. 9168252 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 27, 2015
May 10, 2022U-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. 9283216 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Mar 15, 2016
May 10, 2022U-1819: 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. 9283221 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Mar 15, 2016
May 10, 2022U-1819: 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. 9345701 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: May 24, 2016
May 10, 2022U-1819: 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. 9511066 Abuse-resistant controlled-release opioid dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 003: Dec 6, 2016
May 10, 2022U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): 003: Sep 30, 2014
Apr 4, 2023 
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): 003: Sep 30, 2014
Apr 4, 2023 
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: Aug 3, 2015
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): 003: Dec 20, 2016
Mar 30, 2025 

XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: OPTINOSE US INC      NDA No.: 209022  Prod. No.: 001 RX (0.093MG)
PatentsExpirationPatented Use
Pat. No. 8522778 DP* Nasal devices
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
May 11, 2022 
Pat. No. 8327844 Nasal delivery method
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 17, 2017
Oct 8, 2023U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 7975690 Nasal devices
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 17, 2017
Dec 29, 2025U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10124132 DP* Nasal delivery
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: Dec 6, 2018
Mar 6, 2027U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10076615 Nasal delivery
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Oct 12, 2018
Jul 30, 2029U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 8550073 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Oct 22, 2029 
Pat. No. 8978647 DP* Nasal delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 17, 2017
Dec 6, 2030 
Pat. No. 10252010 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: May 8, 2019
Feb 7, 2031 
Pat. No. 11033696 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 6, 2021
May 20, 2033 
Pat. No. 10179216 DP* Nasal delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Feb 8, 2019
Jul 8, 2033U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10478574 Nasal administration
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 10, 2019
Nov 4, 2033U-2133: Method of delivering fluticasone propionate to a nasal airway
Pat. No. 10076614 DP* Nasal delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 12, 2018
Oct 20, 2034 
Pat. No. 10300229 DP* Nasal delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jun 18, 2019
Jul 7, 2035U-2133: Method of delivering fluticasone propionate to a nasal airway

PROTONIX IV (INJECTABLE) (INTRAVENOUS) PANTOPRAZOLE SODIUM [GENERIC AP]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors
NDA Applicant: WYETH PHARMS      NDA No.: 020988  Prod. No.: 001 RX (EQ 40MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6780881 DP* Freeze-dried pantoprazole preparation and pantoprazole injection
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: None
May 17, 2022 *PED 
Pat. No. 7351723 DP* Freeze-dried pantoprazole preparation and pantoprazole injection
Claim Types: Composition
Pat. Sub. Date(s): 001: None
May 17, 2022 *PED 
Pat. No. 8754108 DP* Freeze-dried pantoprazole preparation and pantoprazole injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 17, 2022 *PED 

ADASUVE (POWDER) (INHALATION) LOXAPINE
Drug Classes: Antipsychotics:1st Generation/Typical
NDA Applicant: ALEXZA PHARMS      NDA No.: 022549  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013
May 20, 2022 
Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Jul 25, 2022 
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 
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. 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 

PEMFEXY (SOLUTION) (INTRAVENOUS) PEMETREXED
Drug Classes: Antineoplastics:Antineoplastics, Other == folate analog metabolic inhibitor
NDA Applicant: EAGLE PHARMS      NDA No.: 209472  Prod. No.: 001 RX (500MG/20ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 7772209 Antifolate combination therapies
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 10, 2020
May 24, 2022U-2728: Use of pemetrexed with prior and/or repeated vitamin B12 and folic acid administration in patients with non-squamous non-small cell lung cancer
U-2729: Use of pemetrexed with prior and/or repeated vitamin B12 and folic acid administration in patients with mesothelioma
Pat. No. 9604990 DS* Crystalline forms of pemetrexed diacid and manufacturing processes therefor
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: Jul 28, 2020
Oct 28, 2035 

ALIMTA (POWDER) (INTRAVENOUS) PEMETREXED DISODIUM [GENERIC AP]
Drug Classes: Antineoplastics:Antineoplastics, Other == folate analog metabolic inhibitor
NDA Applicant: LILLY      NDA No.: 021462  Prod. No.: 001 RX (EQ 500MG BASE/VIAL); 002 RX (EQ 100MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 7772209 Antifolate combination therapies
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: None
May 24, 2022 *PEDU-1296: Use of Pemetrexed with prior and/or repeated vitamin B12 and folic acid administration

RYTARY (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors == Antiparkinson Agents:Antiparkinson Agents, Other == aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX LABS INC      NDA No.: 203312  Prod. No.: 001 RX (23.75MG;95MG); 002 RX (36.25MG;145MG); 003 RX (48.75MG;195MG); 004 RX (61.25MG;245MG)
PatentsExpirationPatented Use
Pat. No. 7094427 DP* DLR* Combination immediate release controlled release levodopa/carbidopa dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jan 27, 2015
May 29, 2022U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
Pat. No. 8377474 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jan 27, 2015
Dec 26, 2028U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
U-219: Treatment of Parkinson's disease
Pat. No. 8454998 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 27, 2015
Dec 26, 2028U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
U-1646: Treatment of post-encephalitic Parkinsonism, and Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
U-1647: Treatment of Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
U-1649: Treatment of post-encephalitic Parkinsonism
U-219: Treatment of Parkinson's disease
Pat. No. 8557283 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 27, 2015
Dec 26, 2028U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
U-219: Treatment of Parkinson's disease
Pat. No. 9089607 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 10, 2015
Dec 26, 2028U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
U-1720: Method of providing a therapeutically effective and stable median blood plasma level of levodopa
Pat. No. 9089608 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 10, 2015
Dec 26, 2028 
Pat. No. 9463246 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Oct 12, 2016
Dec 26, 2028U-219: Treatment of Parkinson's disease
Pat. No. 9533046 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 11, 2017
Dec 26, 2028U-219: Treatment of Parkinson's disease
Pat. No. 9901640 DP* Controlled release formulations of levodopa and uses thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 28, 2018
Dec 26, 2028U-219: Treatment of Parkinson's disease

ADVIL PM (TABLET) (ORAL) DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021394  Prod. No.: 001 OTC (38MG;200MG)
PatentsExpirationPatented Use
Pat. No. 8263647 DP* Treatment of sleep disturbances
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 30, 2022 

VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 001 RX (EQ 20MG BASE;500MG)
PatentsExpirationPatented Use
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 12, 2015
May 31, 2022U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 17, 2015
May 31, 2022U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 23, 2016
May 31, 2022 
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2017
May 31, 2022 
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 3, 2029U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9220698 Method for delivering a pharmaceutical composition to patient in need thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 28, 2016
Mar 10, 2031U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 2, 2015
Oct 17, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin

VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 002 RX (EQ 20MG BASE;375MG)
PatentsExpirationPatented Use
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 12, 2015
May 31, 2022U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 17, 2015
May 31, 2022U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 23, 2016
May 31, 2022 
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 17, 2017
May 31, 2022 
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Aug 17, 2016
Sep 3, 2029U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Mar 2, 2015
Oct 17, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin

YOSPRALA (TABLET, DELAYED RELEASE) (ORAL) ASPIRIN; OMEPRAZOLE
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents == anti-platelet agent == nonsteroidal anti-inflammatory drug == Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other
NDA Applicant: GENUS LIFESCIENCES      NDA No.: 205103  Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
PatentsExpirationPatented Use
Pat. No. 9364439 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
May 31, 2022U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Feb 28, 2023U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 8206741 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Feb 28, 2023U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers
Pat. No. 9987231 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 3, 2018
Jan 2, 2033U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers
Pat. No. 9539214 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 27, 2017
Mar 13, 2033U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers

MYTESI (TABLET, DELAYED RELEASE) (ORAL) CROFELEMER
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents == antidiarrheal
NDA Applicant: NAPO PHARMS INC      NDA No.: 202292  Prod. No.: 001 RX (125MG)
PatentsExpirationPatented Use
Pat. No. 7341744 DP* [Extended 1075 days (2.9 years)]
Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jun 2, 2022U-1319: Symptomatic relief of non-infectious diarrhea
Pat. No. 8962680 Methods and compositions for treating HIV-associated diarrhea
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 24, 2015
Oct 31, 2031U-1319: Symptomatic relief of non-infectious diarrhea
Pat. No. 9585868 Methods and compositions for treating HIV-associated diarrhea
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 24, 2017
Oct 31, 2031U-1319: Symptomatic relief of non-infectious diarrhea

ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
NDA Applicant: ACLARIS      NDA No.: 209305  Prod. No.: 001 DISC (40%)
PatentsExpirationPatented Use
Pat. No. 7381427 Seborrheic keratosis treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 3, 2018
Jun 8, 2022U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 18, 2018
Apr 21, 2035U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Apr 21, 2035U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 10493103 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2020
Apr 21, 2035 
Pat. No. 10729720 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 11, 2020
Apr 21, 2035 
Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 3, 2018
Jul 4, 2035U-2205: Treatment of seborrheic keratoses that are raised

ZYRTEC-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC      NDA No.: 021150  Prod. No.: 002 OTC (5MG;120MG)
PatentsExpirationPatented Use
Pat. No. 7014867 DP* Tablet comprising cetirizine and pseudoephedrine
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jun 10, 2022 
Pat. No. 7226614 Tablet comprising cetirizine and pseudoephedrine
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jun 10, 2022U-295: Treatment of seasonal and perennial allergic rhinitis symptoms

RYANODEX (FOR SUSPENSION) (INTRAVENOUS) DANTROLENE SODIUM
Drug Classes: Antispasticity Agents == skeletal muscle relaxant
NDA Applicant: EAGLE PHARMS      NDA No.: 205579  Prod. No.: 001 RX (250MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 9884044 DP* Treatment using dantrolene
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 6, 2018
Jun 13, 2022U-1546: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk.
Pat. No. 8604072 DP* Treatment using dantrolene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 28, 2014
Jul 20, 2022 
Pat. No. 8110225 DP* Treatment using dantrolene
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jul 28, 2014
Dec 24, 2022 
Pat. No. 8685460 Treatment using dantrolene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 8, 2014
Feb 15, 2023U-1546: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk.
Pat. No. 7758890 DP* Treatment using dantrolene
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 28, 2014
Jun 30, 2025 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJul 22, 2021ODE-69: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk

BETHKIS (SOLUTION) (INHALATION) TOBRAMYCIN [GENERIC AN]
Drug Classes: Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: CHIESI      NDA No.: 201820  Prod. No.: 001 RX (300MG/4ML)
PatentsExpirationPatented Use
Pat. No. 7939502 Optimised formulation of tobramycin for aerosolization
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 30, 2013
Jun 14, 2022U-1324: Management of cystic fibrosis patients
Pat. No. 6987094 DP* Optimized formulation of tobramycin for aerosolization
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 30, 2013
Sep 22, 2022 
Pat. No. 7696178 DP* Optimised formulation of tobramycin for aerosolization
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 30, 2013
Sep 22, 2022 

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 002 RX (EQ 5MG BASE); 003 RX (EQ 10MG BASE); 004 RX (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 17, 2022 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
U-1807: Treatment of pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HEFH)
U-618: Use of rosuvastatin calcium to reduce elevated Total-C, LDL-C, ApoB, nonHDL-C or TG levels; to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis.
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 005 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Jun 17, 2022 *PEDU-618: Use of rosuvastatin calcium to reduce elevated Total-C, LDL-C, ApoB, nonHDL-C or TG levels; to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis.
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

GLEEVEC (CAPSULE) (ORAL) IMATINIB MESYLATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 021335  Prod. No.: 001 DISC (EQ 50MG BASE**); 002 DISC (EQ 100MG BASE**)
PatentsExpirationPatented Use
Pat. No. 6958335 Treatment of gastrointestinal stromal tumors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 19, 2022 *PEDU-791: GLEEVEC is also indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)

GLEEVEC (TABLET) (ORAL) IMATINIB MESYLATE [GENERIC AB]
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 021588  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 400MG BASE)
PatentsExpirationPatented Use
Pat. No. 6958335 Treatment of gastrointestinal stromal tumors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 19, 2022 *PEDU-1883: Treatment of gastrointestinal stromal tumors (GIST)
U-791: GLEEVEC is also indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)

ELESTRIN (GEL, METERED) (TRANSDERMAL) ESTRADIOL
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 021813  Prod. No.: 001 RX (0.06% (0.87GM/ACTIVATION))
PatentsExpirationPatented Use
Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jun 25, 2022 

GELNIQUE 3% (GEL, METERED) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == muscarinic antagonist
NDA Applicant: ALLERGAN      NDA No.: 202513  Prod. No.: 001 DISC (3%)
PatentsExpirationPatented Use
Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 27, 2012
Jun 25, 2022 

JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == HMG-CoA reductase inhibitor (statin) == Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202343  Prod. No.: 001 DISC (10MG;EQ 100MG BASE**); 002 DISC (20MG;EQ 100MG BASE**); 003 DISC (40MG;EQ 100MG BASE**); 004 DISC (10MG;EQ 50MG BASE**); 005 DISC (20MG;EQ 50MG BASE**); 006 DISC (40MG;EQ 50MG BASE**)
PatentsExpirationPatented Use
Pat. No. 8168637 DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 23, 2012; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 26, 2022U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None
Jan 26, 2023 *PEDU-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate
Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None
Jan 26, 2023 *PEDU-1189: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with metformin
U-1190: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with insulin
U-1192: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a sulfonylurea (such as glipizide, glimepiride and glyburide)
U-1193: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a PPAR-gamma agonist (such as pioglitazone and rosiglitazone)
Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process
Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None
Oct 11, 2026 *PEDU-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate

LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC      NDA No.: 020517  Prod. No.: 003 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 8815801 DP* Controlled release composition and method of producing the same
Claim Types: Formulation
Pat. Sub. Date(s): 003: Mar 13, 2015
Jun 28, 2022 
Pat. No. 8921326 DP* Sustained-release composition and method for producing the same
Claim Types: Formulation
Pat. Sub. Date(s): 003: Mar 13, 2015
Feb 5, 2031U-1666: Palliative treatment of prostate cancer

STIVARGA (TABLET) (ORAL) REGORAFENIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BAYER HLTHCARE      NDA No.: 203085  Prod. No.: 001 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7351834 DS* [Extended 898 days (2.5 years)]
.omega.-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Oct 23, 2012
Jun 28, 2022 
Pat. No. 8680124 Treatment of cancers with acquired resistance to kit inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 21, 2014
Jun 2, 2030U-1506: Treatment of patients with gastrointestinal stromal tumor (GIST), including but not limited to patients previously treated with imatinib and patients with GIST having resistance to a KIT tyrosine kinase inhibitor
Pat. No. 8637553 DS* DP* Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Feb 21, 2014
Feb 16, 2031 
Pat. No. 9458107 DP* Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-- ethylpyridie-carboxamide, its salts and monohydrate
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Nov 2, 2016
Apr 8, 2031 
Pat. No. 9957232 DS* 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenox- y]-N-methylpyridine-2-carboxamide monohydrate
Claim Types: Compound; Composition; Method of use; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 30, 2018
Jul 9, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 27, 2024ODE-139: Treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib.

PRADAXA (CAPSULE) (ORAL) DABIGATRAN ETEXILATE MESYLATE [GENERIC AB]
Drug Classes: Blood Products and Modifiers:Anticoagulants == direct thrombin inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 022512  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 110MG BASE)
PatentsExpirationPatented Use
Pat. No. 6087380 DS* DP* [Extended 1409 days (3.9 years)]
Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: None; 002: None; 003: Dec 15, 2015
Jun 28, 2022 *PEDU-1931: Prophylaxis or treatment of venous and arterial thrombotic disease
Pat. No. 9925174 DP* Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol acid ethyl ester and the salts thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 12, 2018
Dec 14, 2023 *PED 
Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Aug 1, 2011; 002: None; 003: Dec 15, 2015
Mar 7, 2026 *PED 
Pat. No. 7866474 DP* DLR* Film container
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 1, 2011; 002: Aug 1, 2011; 003: Dec 15, 2015
Mar 2, 2028 *PED 
Pat. No. 9034822 Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 9, 2015; 002: Nov 9, 2015; 003: Dec 15, 2015
Jul 20, 2031 *PEDU-1759: Method of reversing the anticoagulant effect of dabigatran using idarucizumab
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 21, 2024 PEDI-862: Treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated

PRADAXA (PELLETS) (ORAL) DABIGATRAN ETEXILATE MESYLATE
Drug Classes: Blood Products and Modifiers:Anticoagulants == direct thrombin inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 214358  Prod. No.: 001 RX (EQ 20MG BASE/PACKET); 002 RX (EQ 30MG BASE/PACKET); 003 RX (EQ 40MG BASE/PACKET); 004 RX (EQ 50MG BASE/PACKET); 005 RX (EQ 110MG BASE/PACKET); 006 RX (EQ 150MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6087380 DS* DP* [Extended 1409 days (3.9 years)]
Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
Claim Types: Compound; Method of use
Pat. Sub. Date(s): All strengths: Jul 28, 2021
Jun 28, 2022 *PEDU-3177: Treatment of venous thrombotic disease
U-3178: Reduce the risk of recurrence of venous thrombotic disease
Pat. No. 9925174 DP* Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol acid ethyl ester and the salts thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 28, 2021
Dec 14, 2023 *PED 
Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Jul 28, 2021
Mar 7, 2026 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 21, 2024 PED 

LUSEDRA (SOLUTION) (INTRAVENOUS) FOSPROPOFOL DISODIUM
NDA Applicant: EISAI INC      NDA No.: 022244  Prod. No.: 001 DISC (1050MG/30ML (35MG/ML))
PatentsExpirationPatented Use
Pat. No. 6204257 DS* DP* [Extended 1424 days (3.9 years)]
Water soluble prodrugs of hindered alcohols
Claim Types: Compound; Composition; Process; Method of use
Pat. Sub. Date(s): 001: None
Jul 1, 2022U-945: Sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation

SAXENDA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE RECOMBINANT
Drug Classes: Anti-Obesity Agents == Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 206321  Prod. No.: 001 RX (18MG/3ML (6MG/ML))
PatentsExpirationPatented Use
Pat. No. 8672898 DP* Automatic injection device with reset feature
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2015
Jul 2, 2022 *PED 
Pat. No. 9486588 DP* Automatic injection device with reset feature
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 7, 2016
Jul 2, 2022 *PED 
Pat. No. 8846618 DP* Stable formulation of modified GLP-1
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 17, 2015
Dec 27, 2022 *PED 
Pat. No. 6268343 DS* DP* [Extended 5 years]
Derivatives of GLP-1 analogs
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 21, 2015
Feb 22, 2023 *PEDU-1255: Method for chronic weight management by treating obesity
Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 23, 2019
Dec 30, 2023 *PED 
Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 23, 2019
Nov 23, 2024 *PED 
Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 8, 2019
Jan 20, 2026 
Pat. No. 10376652 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 13, 2019
Jan 20, 2026 
Pat. No. 11311679 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: May 20, 2022
Jan 20, 2026 
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 21, 2015
Feb 13, 2026 *PED 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2015
Apr 20, 2026 *PED 
Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 22, 2021
Jul 17, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 23, 2018
Jul 20, 2026 *PED 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 23, 2018
Jul 20, 2026 *PED 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 18, 2015
Jul 26, 2026 *PED 
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 5, 2015
Jan 17, 2027 *PED 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 13, 2017
Jan 17, 2027 *PED 
Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 1, 2019
Jan 17, 2027 *PED 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 10, 2017
Feb 3, 2027 *PED 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 6, 2017
Aug 27, 2027 *PED 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 26, 2016
Mar 27, 2028 *PED 
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 18, 2015
Aug 1, 2032 *PED 
Pat. No. 9968659 Liraglutide in cardiovascular conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2018
Jul 9, 2037 *PEDU-2438: Cardiovascular outcomes trial of liraglutide 1.8 mg in patients with Type 2 diabetes and cardiovascular disease
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationDec 4, 2023 

ULESFIA (LOTION) (TOPICAL) BENZYL ALCOHOL
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
NDA Applicant: SHIONOGI INC      NDA No.: 022129  Prod. No.: 001 DISC (5%**)
PatentsExpirationPatented Use
Pat. No. 6793931 DP* Ectoparasite asphyxiator compositions and methods for their applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jul 11, 2022U-970: Topical treatment of lice infestations
Pat. No. 7294342 Ectoparasite asphyxiator compositions and methods for their application
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
May 19, 2024U-970: Topical treatment of lice infestations

FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH      NDA No.: 022468  Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 6028071 DS* DP* [Extended 5 years]
Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): All strengths: None
Jul 16, 2022U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma
Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 31, 2025U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma
Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None
May 31, 2025U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

AXID (SOLUTION) (ORAL) NIZATIDINE
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist
NDA Applicant: BRAINTREE      NDA No.: 021494  Prod. No.: 001 DISC (15MG/ML**)
PatentsExpirationPatented Use
Pat. No. 6930119 DP* Liquid pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 17, 2022 

VARITHENA (SOLUTION) (INTRAVENOUS) POLIDOCANOL
Drug Classes: sclerosing agent
NDA Applicant: PROVENSIS      NDA No.: 205098  Prod. No.: 001 RX (180MG/18ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 6846412 DP* Combination filter assembly
Claim Types: Device; Process
Pat. Sub. Date(s): 001: None
Jul 19, 2022 
Pat. No. 8122917 DP* Apparatus and method for dispensing foam
Claim Types: Device; Kit
Pat. Sub. Date(s): 001: None
Sep 9, 2024 
Pat. No. 7731986 DS* DP* Therapeutic foam
Claim Types: Formulation; Drug in a container; Device; Process; Method of use
Pat. Sub. Date(s): 001: None
Nov 17, 2024U-1463: A method of intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities
Pat. No. 7814943 DP* Apparatus and method for dispensing foam
Claim Types: Device; Kit; Method of use
Pat. Sub. Date(s): 001: None
Nov 19, 2027U-1461: A method of generating an injectable foam of controlled density and bubble size
Pat. No. 9480652 DP* Aerosol valve
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Nov 30, 2016
May 12, 2032 

IXEMPRA KIT (INJECTABLE) (INTRAVENOUS) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC      NDA No.: 022065  Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6670384 DP* Methods of administering epothilone analogs for the treatment of cancer
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Jul 23, 2022 *PEDU-959: Method of treating cancer, IV admin, lyophilized ixabepilone diluted, every week or 3 weeks; lyophilized ixabepilone with solvent(dehydrated ethanol) diluted to concentration of 0.1mg/ml to 0.9mg/ml
U-960: Method of treating cancer in a patient comprising intravenously administering to the patient ixabepilone diluted in a parenteral diluent
Pat. No. 7022330 DP* Parenteral formulation for epothilone analogs
Claim Types: Product-by-process; Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: None
Jul 23, 2022 *PEDU-958: Method of treating patient comprising mixing first and second vials of product comprising lyophilized ixabepilone to provide an epothilone analog solution, diluting solution with a suitable diluent to prepare intravenous formulation for PT
Pat. No. RE41393 Treatment of refractory tumors using epothilone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 8, 2022 *PEDU-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone
Pat. No. 7312237 Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 21, 2025 *PEDU-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer

VELCADE (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS) BORTEZOMIB [GENERIC AP]
Drug Classes: proteasome inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021602  Prod. No.: 001 RX (3.5MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6713446 DS* DP* Formulation of boronic acid compounds
Claim Types: Compound; Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: None
Jul 25, 2022 *PED 
Pat. No. 6958319 DS* DP* Formulation of boronic acid compounds
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): 001: None
Jul 25, 2022 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityApr 8, 2022 PEDODE-76: Treatment of patients with mantle cell lymphoma who have not received at least 1 prior therapy

ZETIA (TABLET) (ORAL) EZETIMIBE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == Cardiovascular Agents:Cardiovascular Combinations == dietary cholesterol absorption inhibitor
NDA Applicant: ORGANON      NDA No.: 021445  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7030106 DP* Sterol absorption inhibitor compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 25, 2022 *PED 
Pat. No. 7612058 Methods for inhibiting sterol absorption
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 30, 2026 *PEDU-1027: Reduction of elevated plasma sterol and/or stanol levels in a mammal
U-1173: To reduce elevated total-c, LDL-c, apo b and non-HDL-c in patients with primary hyperlipidemia by administration of ezetimibe alone or in combination with a statin or with fenofibrate

NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.: 207318  Prod. No.: 001 DISC (EQ 17MG BASE)
PatentsExpirationPatented Use
Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 4, 2017
Jul 27, 2022U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016
Jan 15, 2024U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016
Jan 15, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2017
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 25, 2016
Sep 26, 2025 
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 25, 2016
Aug 24, 2026U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: May 25, 2016
Jun 3, 2028 
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: May 25, 2016
Apr 29, 2030 

NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.: 207318  Prod. No.: 002 RX (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jul 27, 2022U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Jul 25, 2018
Sep 26, 2025 
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 24, 2026U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 002: Jul 25, 2018
Jun 3, 2028 
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Jul 25, 2018
Apr 29, 2030 
Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 10, 2020
Mar 23, 2037U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 30, 2021
Mar 23, 2037U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.: 210793  Prod. No.: 001 RX (EQ 34MG BASE)
PatentsExpirationPatented Use
Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jul 27, 2022U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024U-1846: