Pharsight

1. Antara (micronized) patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7101574	LUPIN	Pharmaceutical composition containing fenofibrate and the preparation method	Aug, 2020 (3 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7863331	LUPIN	Pharmaceutical composition containing fenofibrate and method for the preparation thereof	Aug, 2020 (3 years ago)
US8026281	LUPIN	Treating metabolic syndrome with fenofibrate	Apr, 2025 (11 months from now)
US9314447	LUPIN	Reduced dose pharmaceutical compositions of fenofibrate	May, 2033 (9 years from now)

Drugs and Companies using FENOFIBRATE ingredient

Market Authorisation Date: 18 October, 2013

Treatment: Treating hypercholesterolemias with reduction of food effect; Treating primary hypercholesterolemia and mixed dyslipidemia; Treating severe hypertriglyceridemia

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
43 mg and 130 mg	15 Sep, 2008	1	01 Mar, 2012	20 Aug, 2020	Extinguished

Strength	Dosage	Availability
130MG	CAPSULE;ORAL	Prescription
43MG	CAPSULE;ORAL	Prescription
90MG	CAPSULE;ORAL	Discontinued
30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued

ANTARA (MICRONIZED) family patents

2. Brovana patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6040344	LUPIN	Formoterol process	Nov, 2016 (7 years ago)
US6720453	LUPIN	Formoterol tartrate polymorph	Nov, 2021 (2 years ago)
US6472563	LUPIN	Formoterol tartrate process and polymorph	Nov, 2021 (2 years ago)
US7145036	LUPIN	Formoterol tartrate polymorph	Nov, 2021 (2 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6589508	LUPIN	Methods and compositions for treating pulmonary disorders using optically pure (R,R) formoterol	Apr, 2014 (10 years ago)
US7348362	LUPIN	Bronchodilating β-agonist compositions and methods	Jun, 2021 (2 years ago)
US7462645	LUPIN	Bronchodilating beta-agonist compositions and methods	Jun, 2021 (2 years ago)
US6667344	LUPIN	Bronchodilating compositions and methods	Jun, 2021 (2 years ago)
US7473710	LUPIN	Bronchodilating beta-agonist compositions and methods	Jun, 2021 (2 years ago)
US6814953	LUPIN	Bronchodilating compositions and methods	Jun, 2021 (2 years ago)
US7541385	LUPIN	Bronchodilating β-agonist compositions and methods	Jun, 2021 (2 years ago)
US7465756	LUPIN	Bronchodilating beta-agonist compositions and methods	Jun, 2021 (2 years ago)
US8110706	LUPIN	Formoterol tartrate process and polymorph	Nov, 2021 (2 years ago)

Drugs and Companies using ARFORMOTEROL TARTRATE ingredient

Market Authorisation Date: 06 October, 2006

Treatment: For the long term treatment, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis ...

Dosage: SOLUTION;INHALATION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
Eq. 0.015 mg base/ 2 mL	01 Oct, 2009	1		09 Nov, 2021	Extinguished

Strength	Dosage	Availability
EQ 0.015MG BASE/2ML	SOLUTION;INHALATION	Prescription

BROVANA family patents

3. Sesquient patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7635773	LUPIN	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9750822	LUPIN	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US8410077	LUPIN	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9200088	LUPIN	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9493582	LUPIN	Alkylated cyclodextrin compositions and processes for preparing and using the same	Feb, 2033 (8 years from now)

Drugs and Companies using FOSPHENYTOIN SODIUM ingredient

Market Authorisation Date: 05 November, 2020

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)	SOLUTION;INTRAVENOUS	Discontinued

SESQUIENT family patents

4. Solosec patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10682338	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (11 years from now)
US11602522	LUPIN	Secnidazole for use in the treatment of sexually transmitted infection	Sep, 2035 (11 years from now)
US11020377	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (11 years from now)
US11324721	LUPIN	Secnidazole for use in the treatment of trichomoniasis	Sep, 2035 (11 years from now)
US11000508	LUPIN	Secnidazole for use in the treatment of trichomoniasis	Sep, 2035 (11 years from now)
US10335390	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (11 years from now)
US10857133	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (11 years from now)
US11000507	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (11 years from now)
US10849884	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (11 years from now)
US11684607	LUPIN	Secnidazole for use in the treatment of bacterial vaginosis	Sep, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 15, 2022
New Indication(I-866)	Jun 30, 2024
New Patient Population(NPP)	Jan 26, 2025
Generating Antibiotic Incentives Now(GAIN)	Sep 15, 2027

Drugs and Companies using SECNIDAZOLE ingredient

NCE-1 date: 15 September, 2026

Market Authorisation Date: 15 September, 2017

Treatment: Treatment of bacterial vaginosis in adult women; Treatment of trichomoniasis in patients 12 years of age and older; Treatment of bacterial vaginosis in female patients 12 years of age and older

Dosage: GRANULE;ORAL

Strength	Dosage	Availability
2GM/PACKET	GRANULE;ORAL	Prescription

SOLOSEC family patents

5. Xopenex Hfa patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06110646A	2011-11-16	Teva Pharmaceutical Industries Ltd.	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7256310	LUPIN	Levalbuterol salt	Oct, 2024 (5 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5362755	LUPIN	Method for treating asthma using optically pure (R)-albuterol	Mar, 2013 (11 years ago)
US5547994	LUPIN	Method for treating asthma using optically pure R(-) albuterol	Aug, 2013 (10 years ago)
US5605674	LUPIN	Medicinal aerosol formulations	Feb, 2014 (10 years ago)
US5836299	LUPIN	Seals for use in an aerosol delivery device	Nov, 2015 (8 years ago)
US8765153	LUPIN	Levalbuterol salt	Dec, 2023 (4 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-156)	Mar 12, 2018

Drugs and Companies using LEVALBUTEROL TARTRATE ingredient

Market Authorisation Date: 11 March, 2005

Treatment: Treatment or prevention of bronchospasm or asthmatic symptoms

Dosage: AEROSOL, METERED;INHALATION