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: 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. 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. 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* Acylated GLP-1 compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 20, 2017
Jan 29, 2029U-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 

BAQSIMI (POWDER) (NASAL) GLUCAGON
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist; antihypoglycemic agent; gastrointestinal motility inhibitor; glucagon-like peptide-2 (GLP-2) analog
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. 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: 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
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
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
Drug Classes: 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 

ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
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
Drug Classes: 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. 8383150 DP* Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Sep 22, 2026U-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. 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. 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: 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. 8383150 DP* Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Mar 8, 2018
Sep 22, 2026U-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. 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. 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: 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: 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 MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
PatentsExpirationPatented Use
Pat. No. 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. 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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 27, 2020I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 207202  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 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. 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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJul 27, 2020I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

VEMLIDY (TABLET) (ORAL) TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: 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* Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Nov 28, 2016
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): 001: Nov 28, 2016
Aug 15, 2032U-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
Aug 15, 2032U-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
Exclusivity Code: NCE - New chemical entityNov 5, 2020 

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.: 021929  Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH)
PatentsExpirationPatented Use
Pat. No. 7967011 DP* Inhalation device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Feb 11, 2022 *PED 
Pat. No. 7759328 DP* Composition for inhalation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: 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
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): 001: 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): 001: 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. 8875699 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 12, 2014
May 10, 2025 *PED 
Pat. No. 7587988 DP* Inhaler device counter
Claim Types: Device
Pat. Sub. Date(s): 001: None
Oct 10, 2026 *PED 
Pat. No. 8387615 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 4, 2013
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): 001: 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): 001: Jan 29, 2014
Oct 7, 2029 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 11, 2020M-210: Information added to labeling to support the use of SYMBICORT to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD)
Exclusivity Code: M - MiscellaneousDec 20, 2020M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events
Exclusivity Code: NPP - New patient populationJul 27, 2020 PED 

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.: 021929  Prod. No.: 002 RX (0.16MG/INH;0.0045MG/INH)
PatentsExpirationPatented Use
Pat. No. 7967011 DP* Inhalation device
Claim Types: Device
Pat. Sub. Date(s): 002: None
Feb 11, 2022 *PED 
Pat. No. 7759328 DP* Composition for inhalation
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 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. 8143239 DP* Composition for inhalation
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 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): 002: 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): 002: 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. 8875699 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): 002: Dec 12, 2014
May 10, 2025 *PED 
Pat. No. 7587988 DP* Inhaler device counter
Claim Types: Device
Pat. Sub. Date(s): 002: None
Oct 10, 2026 *PED 
Pat. No. 8387615 DP* Inhaler cap strap
Claim Types: Device
Pat. Sub. Date(s): 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): 002: 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): 002: Jan 29, 2014
Oct 7, 2029 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 11, 2020M-210: Information added to labeling to support the use of SYMBICORT to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD)
Exclusivity Code: M - MiscellaneousDec 20, 2020M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events

KYNMOBI (FILM) (SUBLINGUAL) APOMORPHINE HYDROCHLORIDE
Drug Classes: 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. 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. 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. 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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 21, 2023 

SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: partial opioid agonist; 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. 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: 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: proton pump inhibitor
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: 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: 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. RE48286 DS* DP* 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
Nov 16, 2022 
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. 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: NCE - New chemical entityMay 27, 2021 
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]
Drug Classes: vasodilator
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. 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. 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. 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. 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: 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: 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: 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousFeb 6, 2021M-222: Addition of data based on the assessment of safety and efficacy in pediatric patients with major depressive disorder to fulfill postmarketing study requirement 1229-1

TEKTURNA HCT (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor; thiazide diuretic
NDA Applicant: NODEN PHARMA      NDA No.: 022107  Prod. No.: 001 RX (EQ 150MG BASE;12.5MG); 002 RX (EQ 150MG BASE;25MG); 003 RX (EQ 300MG BASE;12.5MG); 004 RX (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 

FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
Drug Classes: 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 

VIMPAT (TABLET) (ORAL) LACOSAMIDE
Drug Classes: antiepileptic drug (AED)
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 3, 2020 

VIMPAT (SOLUTION) (INTRAVENOUS) LACOSAMIDE
Drug Classes: antiepileptic drug (AED)
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 3, 2020M-217: Incorporation of the labeling revisions provided for in NDA 022253/S-039 and NDA 022255/S-022 into the lacosamide injection labeling

VIMPAT (SOLUTION) (ORAL) LACOSAMIDE
Drug Classes: antiepileptic drug (AED)
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 3, 2020 

SPIRIVA (POWDER) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
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 

TRULANCE (TABLET) (ORAL) PLECANATIDE
Drug Classes: 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* 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. 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 24, 2021I-764: Treatment in adult patients for irritable bowel syndrome with constipation (IBS-C)
Exclusivity Code: NCE - New chemical entityJan 19, 2022 

ARESTIN (POWDER, EXTENDED RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline-class drug
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 [GENERIC AB]
Drug Classes: 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: tetracycline-class drug
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

LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON
Drug Classes: adenosine receptor agonist
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJan 17, 2020M-194: Information added to the labeling regarding use of regadenoson administration following an inadequate exercise stress test as compared to regadenoson alone

CONZIP (CAPSULE, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: 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

WELCHOL (BAR, CHEWABLE) (ORAL) COLESEVELAM HYDROCHLORIDE
Drug Classes: bile acid sequestrant
NDA Applicant: DAIICHI SANKYO INC      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
Drug Classes: alpha adrenergic agonist; 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
Pat. No. 7323463 DP* DLR* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Jan 19, 2023 

IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: 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
Drug Classes: 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 
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: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 206162  Prod. No.: 001 RX (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: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 208558  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7151102 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 15, 2017
Apr 29, 2022 
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: 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
Pat. No. 9169235 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: 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): 001: 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): 001: Sep 15, 2017
Oct 11, 2024 
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: 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): 001: Jun 18, 2020
Aug 12, 2027U-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-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
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: 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
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): 001: 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): 001: 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-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 12, 2021I-762: Treatment of deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting
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: NP - New productAug 17, 2020 
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

LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 208558  Prod. No.: 002 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 7151102 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Sep 15, 2017
Apr 29, 2022 
Pat. No. 8912187 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 002: 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
Pat. No. 9169235 Phthalazinone derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 002: 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): 002: 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): 002: Sep 15, 2017
Oct 11, 2024 
Pat. No. 7981889 DS* DP* Phthalazinone derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: 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): 002: Jun 18, 2020
Aug 12, 2027U-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-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-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
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer
Claim Types: Method of use
Pat. Sub. Date(s): 002: 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
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): 002: 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): 002: 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-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 12, 2021I-762: Treatment of deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting
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: NP - New productAug 17, 2020 
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: antiarrhythmic
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
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
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

TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist; opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 205777  Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
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: opioid antagonist; 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 

PROTONIX IV (INJECTABLE) (IV (INFUSION)) PANTOPRAZOLE SODIUM [GENERIC AP]
Drug Classes: proton pump inhibitor
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 

PEMFEXY (SOLUTION) (INTRAVENOUS) PEMETREXED
Drug Classes: 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
Drug Classes: 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: 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: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
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: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 001 RX (EQ 20MG BASE;500MG)
PatentsExpirationPatented Use
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 29, 2013
May 31, 2022 
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. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 28, 2023U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 6, 2020 

VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 002 RX (EQ 20MG BASE;375MG)
PatentsExpirationPatented Use
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 002: Oct 29, 2013
May 31, 2022 
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. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Feb 28, 2023U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 6, 2020 

YOSPRALA (TABLET, DELAYED RELEASE) (ORAL) ASPIRIN; OMEPRAZOLE
Drug Classes: anti-platelet agent; nonsteroidal anti-inflammatory drug; proton pump inhibitor
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: 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
Drug Classes: aldehyde dehydrogenase inhibitor; isocitrate dehydrogenase-2 inhibitor
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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 14, 2020 

ZYRTEC-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: 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: 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. 8110225 DP* Treatment using dantrolene
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jul 28, 2014
Dec 24, 2022 
Pat. No. 8604072 DP* Treatment using dantrolene
Claim Types: Method of use
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
Jul 1, 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: 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 

GLEEVEC (CAPSULE) (ORAL) IMATINIB MESYLATE
Drug Classes: 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: 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 25, 2020ODE-40: Treatment of pediatric patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (ph+ ALL) in combination with chemotherapy, approved under NDA #21588/s-037

JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: HMG CoA-reductase inhibitor; dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202343  Prod. No.: 001 DISC (10MG;EQ 100MG 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
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
Jul 26, 2022U-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
Jul 26, 2022U-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
Apr 11, 2026U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate

JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: HMG CoA-reductase inhibitor; dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202343  Prod. No.: 002 DISC (20MG;EQ 100MG 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): 002: 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): 002: None
Jul 26, 2022U-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): 002: None
Jul 26, 2022U-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): 002: None
Apr 11, 2026U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate

JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: HMG CoA-reductase inhibitor; dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202343  Prod. No.: 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): All strengths: 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): All strengths: None
Jul 26, 2022U-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): All strengths: None
Jul 26, 2022U-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): All strengths: None
Apr 11, 2026U-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: 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: 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: I - New IndicationApr 27, 2020I-744: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
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.
Exclusivity Code: ODE - Orphan drug exclusivityFeb 25, 2020ODE-44: Treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (gist) who have been previously treated with imatinib mesylate and sunitinib malate.

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: 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. 6899699 DP* Automatic injection device with reset feature
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jan 21, 2015
Jul 1, 2022 *PED 
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. 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. 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

TOVIAZ (TABLET, EXTENDED RELEASE) (ORAL) FESOTERODINE FUMARATE [GENERIC AB]
NDA Applicant: PFIZER      NDA No.: 022030  Prod. No.: 001 RX (4MG); 002 RX (8MG)
PatentsExpirationPatented Use
Pat. No. 6858650 DS* [Extended 1149 days (3.1 years)]
Stable salts of novel derivatives of 3,3-diphenylpropylamines
Claim Types: Compound; Process; Method of use
Pat. Sub. Date(s): All strengths: None
Jul 3, 2022U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 7807715 DP* Pharmaceutical compositions comprising fesoterodine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 7, 2027U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 8088398 DP* Pharmaceutical compositions comprising fesoterodine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 7, 2027U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 8501723 DP* Pharmaceutical compositions comprising fesoterodine
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 20, 2013
Jun 7, 2027 

ULESFIA (LOTION) (TOPICAL) BENZYL ALCOHOL
Drug Classes: pediculicide; benzylamine antifungal
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: 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 

WINLEVI (CREAM) (TOPICAL) CLASCOTERONE
NDA Applicant: CASSIOPEA SPA      NDA No.: 213433  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 8865690 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 24, 2022U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 9211295 DP* 17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 24, 2022 
Pat. No. 8143240 17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jan 12, 2023U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 9486458 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 24, 2028U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 10159682 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 4, 2020
Aug 14, 2028U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Pat. No. 9433628 DP* Enzymatic process for obtaining 17.alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition
Pat. Sub. Date(s): 001: Sep 4, 2020
Feb 8, 2029 
Pat. No. 8785427 DP* Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: Sep 4, 2020
Jul 25, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 26, 2025 

VELCADE (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS) BORTEZOMIB
Drug Classes: proteasome inhibitor
NDA Applicant: MILLENNIUM PHARMS      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: dietary cholesterol absorption inhibitor
NDA Applicant: MSD INTL GMBH      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

EVAMIST (SPRAY) (TRANSDERMAL) ESTRADIOL
Drug Classes: estrogen
NDA Applicant: PERRIGO PHARMA INTL      NDA No.: 022014  Prod. No.: 001 RX (1.53MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 6978945 DP* Dispensing device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Jul 31, 2022 

ADDYI (TABLET) (ORAL) FLIBANSERIN
NDA Applicant: SPROUT PHARMS      NDA No.: 022526  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7420057 DS* DP* Stable polymorph of flibanserin
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: Sep 14, 2015
Aug 1, 2022 
Pat. No. 9468639 Treating sexual desire disorders with flibanserin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 8, 2016
Oct 16, 2022U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
Pat. No. 7151103 Method of treating female hypoactive sexual desire disorder with flibanserin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2015
May 9, 2023U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
Pat. No. 8227471 Treating sexual desire disorders with flibanserin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 14, 2015
May 9, 2023U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 18, 2020 

MACRILEN (FOR SOLUTION) (ORAL) MACIMORELIN ACETATE
Drug Classes: growth hormone (GH) secretagogue receptor agonist
NDA Applicant: NOVO      NDA No.: 205598  Prod. No.: 001 RX (EQ 60MG BASE/POUCH)
PatentsExpirationPatented Use
Pat. No. 6861409 DS* DP* Growth hormone secretagogues
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 19, 2018
Aug 1, 2022U-2220: A method for the diagnosis of adult growth hormone deficiency by measuring the level of growth hormone after oral administration of macimorelin
Pat. No. 8192719 Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds
Claim Types: Diagnostic or surgical method; Kit
Pat. Sub. Date(s): 001: Jan 19, 2018
Oct 12, 2027U-2220: A method for the diagnosis of adult growth hormone deficiency by measuring the level of growth hormone after oral administration of macimorelin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 20, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityDec 20, 2024ODE-170: For the diagnosis of adult growth hormone deficiency (AGHD)

NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 022304  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE); 003 RX (EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)]
1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2011
Aug 5, 2022U-931: Relief of moderate to severe acute pain
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None
Jun 27, 2025U-931: Relief of moderate to severe acute pain

NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 203794  Prod. No.: 001 DISC (EQ 20MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)]
1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Aug 5, 2022U-1289: Management of moderate to severe acute pain
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Jun 27, 2025U-1289: Management of moderate to severe acute pain

NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 200533  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)]
1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2011; 002: None; 003: None; 004: None; 005: None
Aug 5, 2022U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 8075872 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 9, 2012; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023 
Pat. No. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 8420056 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: May 2, 2013; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023 
Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None
Oct 10, 2024 
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None
Jun 27, 2025U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Sep 22, 2028U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy

KINEVAC (INJECTABLE) (INJECTION) SINCALIDE
Drug Classes: cholecystokinin (CCK) analog
NDA Applicant: BRACCO      NDA No.: 017697  Prod. No.: 001 RX (0.005MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6803046 DP* Sincalide formulations
Claim Types: Formulation; Process; Kit; Method of use
Pat. Sub. Date(s): 001: None
Aug 16, 2022 

LEVAQUIN (SOLUTION) (ORAL) LEVOFLOXACIN [Has competitive generic]
Drug Classes: quinolone antimicrobial
NDA Applicant: JANSSEN PHARMS      NDA No.: 021721  Prod. No.: 001 DISC (250MG/10ML)
PatentsExpirationPatented Use
Pat. No. 6806256 DP* Taste masked liquid pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 26, 2022 *PED 

DEXYCU KIT (SUSPENSION) (INTRAOCULAR) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: EYEPOINT PHARMS      NDA No.: 208912  Prod. No.: 001 RX (9%)
PatentsExpirationPatented Use
Pat. No. 7560120 DP* Vehicles for delivery of biologically active substances
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 5, 2018
Sep 5, 2022 
Pat. No. 6960346 DP* Vehicles for delivery of biologically active substances
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: Mar 5, 2018
Jul 3, 2023 
Pat. No. 10028965 Use of sustained release dexamethasone in post-cataract surgery inflammation
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 3, 2018
May 23, 2034U-2340: Treatment of postoperative inflammation
Pat. No. 10159683 DP* Use of sustained release dexamethasone in post-cataract surgery inflammation
Claim Types: Kit; Formulation
Pat. Sub. Date(s): 001: Jan 23, 2019
May 23, 2034 
Pat. No. 10022502 Dose guides for injection syringe
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 3, 2018
Jun 22, 2034U-2340: Treatment of postoperative inflammation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 9, 2021 

ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic; beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 203975  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Sep 11, 2022 
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container
Pat. Sub. Date(s): 001: May 14, 2014
Mar 23, 2023U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025 
Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 9, 2014
Apr 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)]
Phenethanolamine derivatives for treatment of respiratory diseases
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014
May 21, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jul 27, 2025U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 8511304 DP* Medicament dispenser
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014
Jun 14, 2027U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pat. No. 9333310 DP* Medicament dispenser
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: May 20, 2016
Oct 2, 2027 
Pat. No. 8113199 DP* Counter for use with a medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Oct 23, 2027 
Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)]
Muscarinic acetylcholine receptor antagonists
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Jan 9, 2014
Dec 18, 2027 
Pat. No. 8161968 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Feb 5, 2028 
Pat. No. 8534281 DP* Manifold for use in medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 9, 2014
Mar 8, 2030 
Pat. No. 8746242 DP* Medicament dispenser
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 26, 2014
Oct 11, 2030 
Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2017
Nov 29, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 9, 2022M-245: Additional information added to the labeling based on safety and efficacy data from the IMPACT trial

ORAVIG (TABLET) (BUCCAL) MICONAZOLE
Drug Classes: azole antifungal
NDA Applicant: FORTOVIA      NDA No.: 022404  Prod. No.: 001 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 6916485 DP* Prolonged release bioadhesive therapeutic systems
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Sep 11, 2022U-1051: Treatment of oropharyngeal candidiasis
Pat. No. 7651698 Prolonged release bioadhesive therapeutic systems
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Sep 11, 2022U-1051: Treatment of oropharyngeal candidiasis
Pat. No. 8518442 DP* Prolonged release bioadhesive therapeutic systems
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 17, 2013
Sep 11, 2022 

VAGIFEM (TABLET) (VAGINAL) ESTRADIOL [GENERIC AB]
Drug Classes: estrogen
NDA Applicant: NOVO NORDISK INC      NDA No.: 020908  Prod. No.: 002 RX (10MCG)
PatentsExpirationPatented Use
Pat. No. 7018992 Hormone composition
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Sep 17, 2022U-1023: Treatment of atrophic vaginitis due to menopause

TRINTELLIX (TABLET) (ORAL) VORTIOXETINE HYDROBROMIDE
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 204447  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 004 RX (EQ 20MG BASE) NDA No.: 204447  Prod. No.: 003 DISC (EQ 15MG BASE**)
PatentsExpirationPatented Use
Pat. No. 8476279 DP* Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 16, 2013
Oct 2, 2022U-1439: Method of treating an affective disorder such as depression
Pat. No. 7144884 DS* DP* Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 16, 2013
Jun 17, 2026U-1439: Method of treating an affective disorder such as depression
Pat. No. 8969355 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 19, 2015
Jun 15, 2027U-1668: Method of treating depression or major depressive disorder
Pat. No. 9125908 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 24, 2018
Jun 15, 2027U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function
Pat. No. 9125909 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 24, 2018
Jun 15, 2027U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function
Pat. No. 9125910 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 24, 2018
Jun 15, 2027U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function
Pat. No. 9227946 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2016
Jun 15, 2027U-1668: Method of treating depression or major depressive disorder
Pat. No. 9861630 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 18, 2018
Jun 15, 2027U-1668: Method of treating depression or major depressive disorder
Pat. No. 8722684 DS* DP* 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process; Formulation
Pat. Sub. Date(s): All strengths: Jun 9, 2014
Jun 30, 2031 
Pat. No. 9278096 Therapeutic uses of compounds having combined SERT, 5-HT.sub.3 and 5-HT.sub.1A activity
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 13, 2018
Mar 21, 2032U-2436: Use in the treatment of major depressive disorder to improve treatment emergent sexual dysfunction (TESD) induced by prior serotonin reuptake inhibitor treatment
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 2, 2021M-227: Addition to the clinical studies section of the labeling with the subsection entitled digit symbol substitution test in major depressive disorder
Exclusivity Code: M - MiscellaneousOct 19, 2021M-234: Update to the prescribing information for vortioxetine on treatment-emergent sexual dysfunction comparing vortioxetine and SSRIS

AVANDAMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: biguanide; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: SB PHARMCO      NDA No.: 021410  Prod. No.: 001 DISC (500MG;EQ 1MG BASE**); 002 DISC (500MG;EQ 2MG BASE**); 003 DISC (500MG;EQ 4MG BASE**); 004 DISC (1GM;EQ 2MG BASE**); 005 DISC (1GM;EQ 4MG BASE**)
PatentsExpirationPatented Use
Pat. No. 8236345 DP* Composition and use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 20, 2012; 002: None; 003: None; 004: None; 005: None
Oct 7, 2022 

WELCHOL (TABLET) (ORAL) COLESEVELAM HYDROCHLORIDE [GENERIC AB]
Drug Classes: bile acid sequestrant
NDA Applicant: DAIICHI SANKYO      NDA No.: 021176  Prod. No.: 001 RX (625MG)
PatentsExpirationPatented Use
Pat. No. 7229613 Method for lowering serum glucose
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 17, 2022 *PEDU-851: Treatment of Type 2 diabetes mellitus

WELCHOL (FOR SUSPENSION) (ORAL) COLESEVELAM HYDROCHLORIDE [Has competitive generic]
Drug Classes: bile acid sequestrant
NDA Applicant: DAIICHI SANKYO      NDA No.: 022362  Prod. No.: 002 RX (3.75GM/PACKET) NDA No.: 022362  Prod. No.: 001 DISC (1.875GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 7229613 Method for lowering serum glucose
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Oct 17, 2022 *PEDU-493: Treatment of Type 2 Diabetes Mellitus

MOVANTIK (TABLET) (ORAL) NALOXEGOL OXALATE
Drug Classes: opioid antagonist
NDA Applicant: REDHILL      NDA No.: 204760  Prod. No.: 001 RX (EQ 12.5MG BASE); 002 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 7662365 DS* DP* Polymer conjugates of opioid antagonists
Claim Types: Composition; Compound
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Oct 18, 2022 
Pat. No. 8617530 Polymer conjugates of opioid antagonists
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Oct 18, 2022U-1185: Treatment of opioid-induced constipation
Pat. No. 7056500 DP* Polymer conjugates of opioid antagonists
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 5, 2015
Jun 29, 2024U-1185: Treatment of opioid-induced constipation
Pat. No. 8067431 Chemically modified small molecules
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Dec 16, 2024U-1185: Treatment of opioid-induced constipation
Pat. No. 7786133 DS* DP* Chemically modified small molecules
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Dec 19, 2027 
Pat. No. 9012469 DS* DP* Crystalline naloxol-peg conjugate
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): All strengths: May 15, 2015
Apr 2, 2032 

SUMAVEL DOSEPRO (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: ENDO VENTURES LTD      NDA No.: 022239  Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8343130 DP* Needleless injector
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 25, 2013
Oct 18, 2022 
Pat. No. 8241244 DP* Needleless injector drug capsule and a method for filling thereof
Claim Types: Process
Pat. Sub. Date(s): 001: Aug 31, 2012
Nov 21, 2022 
Pat. No. 8491524 DP* Needleless injector drug capsule and a method for filling thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 23, 2013
Nov 21, 2022 
Pat. No. 8267903 DP* Casing
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 10, 2012
Mar 18, 2023 
Pat. No. 8118771 DP* Needleless injector drug capsule and a method for filling thereof
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 9, 2012
Aug 10, 2023 
Pat. No. 8241243 DP* Needleless injector drug capsule and a method for filling thereof
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 31, 2012
Aug 10, 2023 
Pat. No. 8287489 DP* Device for readying a needle free injector for delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 16, 2012
Dec 6, 2024 
Pat. No. 7901385 DP* Casing
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 23, 2011
Jul 31, 2026 
Pat. No. 7776007 DP* Device for readying a needle free injector for delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 4, 2011
Nov 22, 2026 

HALFLYTELY (FOR SOLUTION, TABLET, DELAYED RELEASE) (ORAL) BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Drug Classes: stimulant laxative; osmotic laxative
NDA Applicant: BRAINTREE      NDA No.: 021551  Prod. No.: 003 DISC (5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM**)
PatentsExpirationPatented Use
Pat. No. 7291324 Method of bowel cleansing
Claim Types: Method of use
Pat. Sub. Date(s): 003: None
Oct 22, 2022U-837: Gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults

SINGULAIR (GRANULE) (ORAL) MONTELUKAST SODIUM [GENERIC AB]
Drug Classes: leukotriene receptor antagonist (LTRA)
NDA Applicant: MERCK      NDA No.: 021409  Prod. No.: 001 RX (EQ 4MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 8007830 DP* Granule formation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 29, 2011
Oct 24, 2022 

TRI-LUMA (CREAM) (TOPICAL) FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Drug Classes: corticosteroid; melanin synthesis inhibitor; retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 021112  Prod. No.: 001 RX (0.01%;4%;0.05%)
PatentsExpirationPatented Use
Pat. No. 8247395 DP* Topical skin care composition
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Oct 5, 2012
Oct 25, 2022 
Pat. No. 8653053 DP* Topical skin care composition
Claim Types: Product-by-process; Formulation
Pat. Sub. Date(s): 001: Mar 14, 2014
Oct 25, 2022 
Pat. No. 7915243 DP* Topical skin care composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 31, 2011
Sep 8, 2023 
Pat. No. 7939516 DP* Topical skin care composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 17, 2011
Sep 8, 2023 

RYDAPT (CAPSULE) (ORAL) MIDOSTAURIN
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 207997  Prod. No.: 001 RX (25MG)
PatentsExpirationPatented Use
Pat. No. 8222244 Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 23, 2017
Oct 29, 2022U-2007: Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy
Pat. No. 7973031 Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 23, 2017
Oct 17, 2024U-2007: Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy
Pat. No. 8575146 Pharmaceutical uses of staurosporine derivatives
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 23, 2017
Dec 2, 2030U-2008: Treatment of adult patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 28, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityApr 28, 2024ODE-140: Treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)
Exclusivity Code: ODE - Orphan drug exclusivityApr 28, 2024ODE-141: Treatment of adult patients with newly diagnosed acute myeloid leukemia (aml) that is flt3 mutation-positive as detected by an FDA approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation

HORIZANT (TABLET, EXTENDED RELEASE) (ORAL) GABAPENTIN ENACARBIL
Drug Classes: antiepileptic drug (AED)
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 022399  Prod. No.: 001 RX (600MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 8048917 DS* DP* Prodrugs of GABA analogs, compositions and uses thereof
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 21, 2011; 002: Jan 5, 2012
Nov 6, 2022U-1247: Management of postherpetic neuralgia (PHN) in adults
Pat. No. 8686034 Crystalline form of .gamma.-aminobutyric acid analog
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 28, 2014
Jan 24, 2025U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
U-1247: Management of postherpetic neuralgia (PHN) in adults
Pat. No. 6818787 DS* DP* [Extended 882 days (2.4 years)]
Prodrugs of GABA analogs, compositions and uses thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Apr 19, 2011; 002: Jan 5, 2012
Apr 6, 2025 
Pat. No. 8114909 Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2012; 002: None
Apr 11, 2026U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
Pat. No. 8026279 DS* DP* Crystalline form of .gamma.-aminobutyric acid analog
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Oct 24, 2011; 002: Jan 5, 2012
Nov 10, 2026 
Pat. No. 8795725 DP* GABA analog prodrug sustained release oral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 27, 2014
Jun 10, 2029U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
U-1247: Management of postherpetic neuralgia (PHN) in adults

XERESE (CREAM) (TOPICAL) ACYCLOVIR; HYDROCORTISONE
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor; corticosteroid
NDA Applicant: BAUSCH      NDA No.: 022436  Prod. No.: 001 RX (5%;1%)
PatentsExpirationPatented Use
Pat. No. 7223387 DP* Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Nov 13, 2022U-1006: New combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolescents (12 years of age and older)
U-1484: Combination product for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older)

XOFIGO (SOLUTION) (INTRAVENOUS) RADIUM RA-223 DICHLORIDE
Drug Classes: alpha particle-emitting radioactive therapeutic agent
NDA Applicant: BAYER HLTHCARE      NDA No.: 203971  Prod. No.: 001 RX (162mCi/6ML (27mCi/ML))
PatentsExpirationPatented Use
Pat. No. 6635234 [Extended 1049 days (2.9 years)]
Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 11, 2013
Nov 17, 2022U-2271: Therapeutic treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease

AMLODIPINE BESYLATE (TABLET, ORALLY DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: SYNTHON PHARMS      NDA No.: 022026  Prod. No.: 001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003 DISC (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 6828339 DS* Amlodipine salt forms and processes for preparing them
Claim Types: New polymorph, salt or hydrate; Formulation
Pat. Sub. Date(s): All strengths: None
Nov 20, 2022 

NEURONTIN (SOLUTION) (ORAL) GABAPENTIN [GENERIC AA]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: UPJOHN      NDA No.: 021129  Prod. No.: 001 RX (250MG/5ML)
PatentsExpirationPatented Use
Pat. No. 7256216 DP* Liquid pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 28, 2022 *PED 

VIIBRYD (TABLET) (ORAL) VILAZODONE HYDROCHLORIDE [GENERIC AB]
NDA Applicant: ALLERGAN      NDA No.: 022567  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7834020 DS* DP* Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Pat. Sub. Date(s): 001: Jan 25, 2011; 002: None; 003: None
Dec 5, 2022 *PEDU-839: Treatment of major depressive disorder (MDD)
Pat. No. 8193195 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 14, 2012
Dec 5, 2022 *PEDU-839: Treatment of major depressive disorder (MDD)
Pat. No. 8236804 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 14, 2012; 002: None; 003: None
Dec 5, 2022 *PEDU-839: Treatment of major depressive disorder (MDD)
Pat. No. 8673921 DS* DP* Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Mar 21, 2014
Dec 5, 2022 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 31, 2023 PEDM-254: Information added to the labeling regarding pediatric patients ages 7 to 17 years of age with major depressive disorder

HETLIOZ (CAPSULE) (ORAL) TASIMELTEON
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC      NDA No.: 205677  Prod. No.: 001 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 5856529 DS* DP* [Extended 5 years]
Benzofuran and dihydrobenzofuran melatonergic agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None
Dec 9, 2022U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon
Pat. No. RE46604 Treatment of circadian rhythm disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 30, 2017
Jan 25, 2033U-2147: Treatment of non-24 hour sleep-wake disorder by orally administering 20mg of tasimelteon once daily before bedtime
Pat. No. 9060995 Treatment of circadian rhythm disorders
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jun 26, 2015
Jan 25, 2033U-1710: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with fluvoxamine
Pat. No. 9539234 Treatment of circadian rhythm disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 11, 2017
Jan 25, 2033U-1934: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor
Pat. No. 9549913 Treatment of circadian rhythm disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 27, 2017
Jan 25, 2033U-1486: Treatment of non-24-hour sleep-wake disorder
Pat. No. 9855241 Treatment of circadian rhythm disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2018
Jan 25, 2033U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon
Pat. No. 10149829 Treatment of circadian rhythm disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 27, 2018
Jan 25, 2033U-2477: Treatment of non-24 hour sleep-wake disorder by avoiding the use of tasimelteon in combination with CYP1A2 strong inhibitors
Pat. No. 10449176 Treatment of circadian rhythm disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 20, 2019
Jan 25, 2033U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon
Pat. No. 10610510 Treatment of circadian rhythm disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 8, 2020
Jan 25, 2033U-2805: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon to patients with a smoking history
Pat. No. 9730910 Treatment of circadian rhythm disorders
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 22, 2017
May 17, 2034U-2085: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with rifampin
Pat. No. 10610511 Method of treatment
Claim Types: Method of use; Method of improving a treatment
Pat. Sub. Date(s): 001: May 8, 2020
Oct 10, 2034U-2806: Treatment of non-24 hour sleep-wake disorder by avoiding the administration of food
Pat. No. 10071977 DS* DP* Highly purifid pharmaceutical grade tasimelteon
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 17, 2018
Feb 12, 2035 
Pat. No. 10376487 Method of treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 11, 2019
Jul 27, 2035U-2615: Treatment of non-24 hour sleep-wake disorder by avoiding the administration of tasimelteon with food
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 31, 2021ODE-59: Treatment of non-24-hour sleep-wake disorder

DORYX (TABLET, DELAYED RELEASE) (ORAL) DOXYCYCLINE HYCLATE [GENERIC AB]
Drug Classes: tetracycline-class drug
NDA Applicant: MAYNE PHARMA      NDA No.: 050795  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 80MG BASE); 005 RX (EQ 200MG BASE); 006 RX (EQ 50MG BASE)
PatentsExpirationPatented Use
Pat. No. 6958161 DP* Modified release coated drug preparation
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: May 30, 2013; 005: None; 006: Feb 10, 2015
Dec 15, 2022U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet
Pat. No. 8715724 DP* Tabletting process
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: May 7, 2014; 002: May 7, 2014; 003: May 7, 2014; 004: May 7, 2014; 005: May 7, 2014; 006: Feb 10, 2015
Feb 3, 2028 

DORYX MPC (TABLET, DELAYED RELEASE) (ORAL) DOXYCYCLINE HYCLATE
Drug Classes: tetracycline-class drug
NDA Applicant: MAYNE PHARMA      NDA No.: 050795  Prod. No.: 008 RX (EQ 120MG BASE) NDA No.: 050795  Prod. No.: 007 DISC (EQ 60MG BASE**)
PatentsExpirationPatented Use
Pat. No. 6958161 DP* Modified release coated drug preparation
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: May 23, 2016
Dec 15, 2022U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet
Pat. No. 8715724 DP* Tabletting process
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: May 23, 2016
Feb 3, 2028 
Pat. No. 9295652 DP* Controlled release doxycycline
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 23, 2016
Oct 23, 2034U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet
Pat. No. 9511031 DP* Controlled release doxycycline
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 5, 2017
Oct 23, 2034 
Pat. No. 9446057 DP* Controlled release doxycycline
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 9, 2016
Dec 23, 2034U-918: To treat or prevent infections caused by susceptible bacteria using delayed-release tablets consisting of doxycycline hyclate coated pellets in a tablet

VARUBI (TABLET) (ORAL) ROLAPITANT HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: TERSERA      NDA No.: 206500  Prod. No.: 001 RX (EQ 90MG BASE)
PatentsExpirationPatented Use
Pat. No. 8796299 NK1 antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 25, 2015
Dec 17, 2022U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 7049320 DS* DP* NK.sub.1 antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 25, 2015
Dec 8, 2023U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 7563801 DP* Pharmaceutical formulations: salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Sep 25, 2015
Apr 4, 2027 
Pat. No. 7981905 Pharmaceutical formulations: salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-Ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 25, 2015
Apr 4, 2027U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 8178550 DS* DP* Hydrochloride salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy)-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and preparation process therefor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Sep 25, 2015
Apr 4, 2027 
Pat. No. 8404702 Pharmaceutical formulations:salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-sp- iro[4.5]decan-2-one and treatment methods using the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 25, 2015
Apr 4, 2027U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 8470842 Hydrochloride salts of 8-[{1-(3,5-Bis-trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza- -spiro[4.5]decan-2-one and preparation process therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 25, 2015
Jan 18, 2029U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 8361500 DP* Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz-
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 25, 2015
Oct 9, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 1, 2020 

VARUBI (EMULSION) (INTRAVENOUS) ROLAPITANT HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: TERSERA      NDA No.: 208399  Prod. No.: 001 DISC (EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 8796299 NK1 antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2017
Dec 17, 2022U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 7049320 DS* DP* NK.sub.1 antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 16, 2017
Dec 8, 2023U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 7981905 Pharmaceutical formulations: salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-Ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 22, 2017
Apr 4, 2027U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 8178550 DS* DP* Hydrochloride salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy)-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and preparation process therefor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Nov 22, 2017
Apr 4, 2027 
Pat. No. 8404702 Pharmaceutical formulations:salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-sp- iro[4.5]decan-2-one and treatment methods using the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 22, 2017
Apr 4, 2027U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 8470842 Hydrochloride salts of 8-[{1-(3,5-Bis-trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza- -spiro[4.5]decan-2-one and preparation process therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 22, 2017
Jan 18, 2029U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
Pat. No. 9101615 Intravenous formulations of neurokinin-1 antagonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 22, 2017
Jul 14, 2032U-1741: Prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 1, 2020 

XYWAV (SOLUTION) (ORAL) CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ      NDA No.: 212690  Prod. No.: 001 RX (0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML)
PatentsExpirationPatented Use
Pat. No. 8731963 Sensitive drug distribution system and method
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Aug 19, 2020
Dec 17, 2022U-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution
Pat. No. 8591922 DP* Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 19, 2020
Jan 11, 2033 
Pat. No. 8901173 DP* Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Aug 19, 2020
Jan 11, 2033 
Pat. No. 9132107 DP* Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Aug 19, 2020
Jan 11, 2033 
Pat. No. 10195168 DP* Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 19, 2020
Jan 11, 2033 
Pat. No. 10675258 Method of using gamma-hydroxybutyrate compositions for the treatment of disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 19, 2020
Jan 11, 2033U-2938: Treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of GHB
Pat. No. 8772306 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 19, 2020
Mar 15, 2033U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.
Pat. No. 9050302 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Claim Types: Method of administration; method of improving a treatment
Pat. Sub. Date(s): 001: Aug 19, 2020
Mar 15, 2033U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.
Pat. No. 9486426 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 19, 2020
Mar 15, 2033U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered.
Pat. No. 10213400 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Aug 19, 2020
Mar 15, 2033U-2499: Method of reducing adverse effects in patients suffering from excessive daytime sleepiness and/or cataplexy in narcolepsy who are concomitantly administered sodium oxybate and divalproex sodium
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 21, 2023 

ZIOPTAN (SOLUTION/DROPS) (OPHTHALMIC) TAFLUPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: AKORN      NDA No.: 202514  Prod. No.: 001 RX (0.0015%)
PatentsExpirationPatented Use
Pat. No. 5886035 DS* DP* [Extended 5 years]
Difluoroprostaglandin derivatives and their use
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Feb 27, 2012
Dec 18, 2022U-778: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9999593 DP* Method and composition for treating ocular hypertension and glaucoma
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 9, 2018
May 28, 2029 

OFORTA (TABLET) (ORAL) FLUDARABINE PHOSPHATE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.: 022273  Prod. No.: 001 DISC (10MG)
PatentsExpirationPatented Use
Pat. No. 7148207 DP* Oral fludara of high-purity formulation with quick release of active ingredient
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Dec 20, 2022U-944: Treatment of patients with B-cell chronic lymphocytic leukemia (CLL)

EPIDUO (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 022320  Prod. No.: 001 RX (0.1%;2.5%)
PatentsExpirationPatented Use
Pat. No. 8105618 Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 29, 2012
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8241649 DP* Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Aug 14, 2012
Dec 23, 2022 
Pat. No. 8809305 Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Sep 19, 2014
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8936800 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Mar 19, 2015
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 7964202 DP* Method for treatment of common acne
Claim Types: Method of use; Drug in a container
Pat. Sub. Date(s): 001: Jun 23, 2011
Sep 1, 2024U-1078: Treatment of acne
Pat. No. 7820186 DP* Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 2, 2010
Nov 23, 2025 
Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 19, 2013
Jul 12, 2027U-1078: Treatment of acne
Pat. No. 8071644 DP* Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2011
Jul 18, 2027U-1078: Treatment of acne
Pat. No. 8080537 Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Dec 21, 2011
Jul 18, 2027U-1078: Treatment of acne
Pat. No. 8129362 Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 4, 2012
Jul 18, 2027U-1078: Treatment of acne

EPIDUO FORTE (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS      NDA No.: 207917  Prod. No.: 001 RX (0.3%;2.5%)
PatentsExpirationPatented Use
Pat. No. 8445543 Combinations of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jul 24, 2015
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8785420 Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2015
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8809305 Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 29, 2016
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8936800 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Jul 24, 2015
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 9814690 DP* Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Claim Types: Formulation; Method of use; Drug in a container
Pat. Sub. Date(s): 001: Dec 12, 2017
Dec 23, 2022U-1078: Treatment of acne
Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2015
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 8729127 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2015
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 9381179 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 4, 2016
Mar 12, 2023U-1078: Treatment of acne
Pat. No. 9387187 Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 5, 2016
Mar 12, 2023U-1078: Treatment of acne

ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUDAX      NDA No.: 210583  Prod. No.: 001 RX (30MG/ML (30MG/ML))
PatentsExpirationPatented Use
Pat. No. 8512727 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Mar 6, 2020
Dec 25, 2022U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10463673 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10471067 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Mar 6, 2020
Feb 24, 2024U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 9974746 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 6, 2020
May 26, 2030 
Pat. No. 10709713 Nanoparticulate meloxicam formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 24, 2020
May 26, 2030U-2750: Management of moderate-to-severe pain by intravenous injection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 20, 2023 


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 18 November 2020
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