Pharsight

1. Amzeeq patent 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).
US10086080	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)
US10137200	JOURNEY	Surfactant-free water-free foamable compositions, breakable foams and gels and their uses	Oct, 2030 (5 years from now)
US10213512	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)
US10265404	JOURNEY	Compositions, gels and foams with rheology modulators and uses thereof	Oct, 2030 (5 years from now)
US10517882	JOURNEY	Method for healing of an infected acne lesion without scarring	Oct, 2030 (5 years from now)
US10821187	JOURNEY	Compositions, gels and foams with rheology modulators and uses thereof	Oct, 2030 (5 years from now)
US8945516	JOURNEY	Surfactant-free water-free foamable compositions, breakable foams and gels and their uses	Oct, 2030 (5 years from now)
US8992896	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)
US9675700	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)

Drugs and Companies using MINOCYCLINE HYDROCHLORIDE ingredient

Market Authorisation Date: 18 October, 2019

Treatment: Treatment of non-nodular acne vulgaris

Dosage: AEROSOL, FOAM

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.04	11 May, 2021	1		08 Sep, 2037

Strength	Dosage	Availability
EQ 4% BASE	AEROSOL, FOAM	Prescription

AMZEEQ family patents

2. Auvelity patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP15861189A	2021-05-31	Elkington and Fife LLP	Granted and Under Opposition

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).
US10058518	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10064857	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10080727	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10092560	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10092561	AXSOME	Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan	Nov, 2034 (9 years from now)
US10105327	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphane and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10105361	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10251879	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10463634	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10512643	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10548857	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10596167	AXSOME	Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan	Nov, 2034 (9 years from now)
US10772850	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10780064	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (14 years from now)
US10780066	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10786469	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10786496	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10799497	AXSOME	Combination of dextromethorphan and bupropion for treating depression	Nov, 2034 (9 years from now)
US10806710	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10864209	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10874663	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10874664	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10874665	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10881624	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US10881657	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10894046	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10894047	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10898453	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10925842	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (14 years from now)
US10933034	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10940124	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (14 years from now)
US10945973	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10966941	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US10966942	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (14 years from now)
US10966974	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11020389	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11058648	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11090300	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11096937	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11123343	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11129826	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11141388	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11141416	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11147808	AXSOME	Method of decreasing the fluctuation index of dextromethorphan	Nov, 2034 (9 years from now)
US11185515	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11191739	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11197839	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11207281	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11213521	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11229640	AXSOME	Combination of dextromethorphan and bupropion for treating depression	Nov, 2034 (9 years from now)
US11234946	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11253491	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11253492	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11273133	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11273134	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11285118	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11285146	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11291638	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11291665	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11298351	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11298352	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11311534	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11344544	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11357744	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11364233	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11382874	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11419867	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11426370	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11426401	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11433067	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11478468	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11497721	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11510918	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11517542	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11517543	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11524007	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US11524008	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US9168234	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US9198905	AXSOME	Compositions and methods for reducing dextrorphan plasma levels and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9205083	AXSOME	Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan	Nov, 2034 (9 years from now)
US9238032	AXSOME	Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan	Nov, 2034 (9 years from now)
US9278095	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US9314462	AXSOME	Compositions and methods for increasing dextromethorphan plasma levels and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9370513	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9375429	AXSOME	Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan	Nov, 2034 (9 years from now)
US9408815	AXSOME	Bupropion as a modulator of drug activity	Nov, 2034 (9 years from now)
US9457025	AXSOME	Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan	Nov, 2034 (9 years from now)
US9486450	AXSOME	Hydroxybupropion and related compounds as modulators of drug plasma levels	Nov, 2034 (9 years from now)
US9700528	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9700553	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9707191	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9763932	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9861595	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9867819	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)
US9968568	AXSOME	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects	Nov, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Aug 18, 2025

Drugs and Companies using BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE ingredient

Market Authorisation Date: 18 August, 2022

Treatment: Dextromethorphan and bupropion in combination to treat major depressive disorder

Dosage: TABLET, EXTENDED RELEASE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
45 mg/105 mg	22 Dec, 2022	1		07 Jan, 2040

Strength	Dosage	Availability
105MG;45MG	TABLET, EXTENDED RELEASE	Prescription

AUVELITY family patents

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3. Caplyta patent 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).
US10117867	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	May, 2029 (3 years from now)
US10464938	INTRA-CELLULAR	Pharmaceutical compositions comprising ((6bR,10aS)-1-(4-fluorophenyl)-4-(3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)butan-1-one or pharmaceutically acceptable salts thereof	Mar, 2028 (2 years from now)
US8598119	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	Dec, 2029 (4 years from now)
US9616061	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	May, 2029 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-882)	Dec 17, 2024
New Chemical Entity Exclusivity(NCE)	Dec 20, 2024

Drugs and Companies using LUMATEPERONE TOSYLATE ingredient

NCE-1 date: 21 December, 2023

Market Authorisation Date: 22 April, 2022

Treatment: Treatment of bipolar depression; Treatment of schizophrenia

Dosage: CAPSULE

Strength	Dosage	Availability
EQ 42MG BASE	CAPSULE	Prescription
EQ 10.5MG BASE	CAPSULE	Prescription
EQ 21MG BASE	CAPSULE	Prescription

CAPLYTA family patents

4. Copiktra patent 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.
US8193182	SECURA	Substituted isoquinolin-1(2H)-ones, and methods of use thereof	Feb, 2030 (4 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9216982	SECURA	Certain chemical entities, compositions and methods	Jan, 2029 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 24, 2023
Orphan Drug Exclusivity(ODE-208)	Sep 24, 2025
Orphan Drug Exclusivity(ODE-209)	Sep 24, 2025

Drugs and Companies using DUVELISIB ingredient

NCE-1 date: 24 September, 2022

Market Authorisation Date: 24 September, 2018

Treatment: For the treatment of patients with chronic lymphocytic leukemia (cll) and/or small lymphocytic leukemia (sll)

Dosage: CAPSULE

Strength	Dosage	Availability
15MG	CAPSULE	Prescription
25MG	CAPSULE	Prescription

COPIKTRA family patents

5. Drospirenone patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP19209672A	2022-10-12	Luigi, Rumi	Granted and Under Opposition
EP19209672A	2022-10-12	Adalvo Ltd.	Granted and Under Opposition

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).
US10179140	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)
US10603281	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)
US10849857	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)
US11123299	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11291632	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11291633	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11413249	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11439598	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11504334	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US9603860	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jun 29, 2025

Drugs and Companies using DROSPIRENONE ingredient

Market Authorisation Date: 29 June, 2022

Treatment: Prevention of pregnancy in females of reproductive age

Dosage: TABLET, CHEWABLE

Strength	Dosage	Availability
3.5MG	TABLET, CHEWABLE	Discontinued

DROSPIRENONE family patents

6. Duzallo patent 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).
US10183012	IRONWOOD PHARMS INC	Compounds and compositions and methods of use	Nov, 2028 (3 years from now)
US8084483	IRONWOOD PHARMS INC	Compounds and compositions and methods of use	Aug, 2029 (4 years from now)
US8283369	IRONWOOD PHARMS INC	Compounds and compositions and methods of use	Nov, 2028 (3 years from now)
US8357713	IRONWOOD PHARMS INC	Compounds and compositions and methods of use	Dec, 2029 (4 years from now)
US8546437	IRONWOOD PHARMS INC	Compounds and compositions and methods of use	Apr, 2029 (3 years from now)

Drugs and Companies using ALLOPURINOL; LESINURAD ingredient

Market Authorisation Date: 18 August, 2017

Treatment: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone

Dosage: TABLET

Strength	Dosage	Availability
200MG;200MG	TABLET	Discontinued
300MG;200MG	TABLET	Discontinued

DUZALLO family patents

7. Ezallor Sprinkle patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10413543	SUN PHARM	Stable multiparticulate pharmaceutical composition of rosuvastatin	Feb, 2036 (10 years from now)

Drugs and Companies using ROSUVASTATIN CALCIUM ingredient

Market Authorisation Date: 18 December, 2018

Treatment: NA

Dosage: CAPSULE

Strength	Dosage	Availability
EQ 5MG BASE	CAPSULE	Discontinued
EQ 10MG BASE	CAPSULE	Discontinued
EQ 20MG BASE	CAPSULE	Discontinued
EQ 40MG BASE	CAPSULE	Discontinued

EZALLOR SPRINKLE family patents

8. Fleqsuvy patent 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).
US11324696	AZURITY	Suspensions and diluents for metronidazole and baclofen	Sep, 2037 (12 years from now)
US11446246	AZURITY	Suspensions and diluents for metronidazole and baclofen	Sep, 2037 (12 years from now)

Drugs and Companies using BACLOFEN ingredient

Market Authorisation Date: 04 February, 2022

Treatment: Indicated for the treatment of spasticity resulting from multiple sclerosis

Dosage: SUSPENSION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg/5 mL	20 May, 2022	1	08 Jun, 2023	29 Sep, 2037	Eligible

Strength	Dosage	Availability
25MG/5ML	SUSPENSION	Prescription

FLEQSUVY family patents

9. Galafold patent 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).
US10383864	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (1 year, 11 months from now)
US10406143	AMICUS THERAP US	Methods for treatment of fabry disease	May, 2027 (1 year, 11 months from now)
US11241422	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (1 year, 11 months from now)
US9000011	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (1 year, 11 months from now)
US9480682	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (1 year, 11 months from now)
US9987263	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (1 year, 11 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 10, 2023
Orphan Drug Exclusivity(ODE-205)	Aug 10, 2025

Drugs and Companies using MIGALASTAT HYDROCHLORIDE ingredient

NCE-1 date: 10 August, 2022

Market Authorisation Date: 10 August, 2018

Treatment: The treatment of fabry patients

Dosage: CAPSULE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
123 mg	10 Aug, 2022	3		06 Feb, 2039

Strength	Dosage	Availability
EQ 123MG BASE	CAPSULE	Prescription

GALAFOLD family patents

10. Givlaari patent expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9150605	November, 2010	Decision	Charles Allerson et al

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.
US9150605	ALNYLAM PHARMS INC	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Aug, 2025 (2 months from now)
US9708610	ALNYLAM PHARMS INC	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Jan, 2024 (1 year, 4 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 20, 2024
Orphan Drug Exclusivity(ODE-273)	Nov 20, 2026

Drugs and Companies using GIVOSIRAN SODIUM ingredient

NCE-1 date: 21 November, 2023

Market Authorisation Date: 20 November, 2019

Treatment: Treatment of acute hepatic porphyria

Dosage: SOLUTION

Strength	Dosage	Availability
EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION	Prescription

GIVLAARI family patents

11. Gocovri patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP10835150A	2017-04-20	Ahrens, Gabriele	Patent maintained as amended

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).
US11197835	SUPERNUS PHARMS	Method of administering amantadine prior to a sleep period	Dec, 2030 (5 years from now)
US8741343	SUPERNUS PHARMS	Method of administering amantadine prior to a sleep period	Dec, 2030 (5 years from now)
US9867791	SUPERNUS PHARMS	Method of administering amantadine prior to a sleep period	Dec, 2030 (5 years from now)
US9867792	SUPERNUS PHARMS	Method of administering amantadine prior to a sleep period	Dec, 2030 (5 years from now)
US9867793	SUPERNUS PHARMS	Method of administering amantadine prior to a sleep period	Dec, 2030 (5 years from now)
US9877933	SUPERNUS PHARMS	Method of administering amantadine prior to a sleep period	Dec, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-769)	Aug 24, 2020
New Product(NP)	Aug 24, 2020
Orphan Drug Exclusivity(ODE)	Aug 24, 2024
Orphan Drug Exclusivity(ODE-153)	Aug 24, 2024

Drugs and Companies using AMANTADINE HYDROCHLORIDE ingredient

Market Authorisation Date: 24 August, 2017

Treatment: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications; Treatment of dyskinesia and increasing on time with...

Dosage: CAPSULE, EXTENDED RELEASE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
137 mg	16 Jan, 2018	1		02 Dec, 2030
68.5 mg	30 Apr, 2020	1		04 Dec, 2034

Strength	Dosage	Availability
EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE	Prescription
EQ 137MG BASE	CAPSULE, EXTENDED RELEASE	Prescription

GOCOVRI family patents

12. Kloxxado patent 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).
US10722510	HIKMA	Liquid naloxone spray	Aug, 2034 (9 years from now)
US10973814	HIKMA	Liquid naloxone spray	Aug, 2034 (9 years from now)
US11135155	HIKMA	Liquid naloxone spray	Aug, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Apr 29, 2024

Drugs and Companies using NALOXONE HYDROCHLORIDE ingredient

Market Authorisation Date: 29 April, 2021

Treatment: Use of naloxone for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients

Dosage: SPRAY

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
8 mg/spray	30 Mar, 2023	1		26 Aug, 2034

Strength	Dosage	Availability
8MG/SPRAY	SPRAY	Prescription

KLOXXADO family patents

13. Leqvio patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP10008929A	2015-10-06	Quark Pharmaceuticals, Inc.	Patent maintained as amended
EP10008931A	2013-07-26	Alnylam Pharmaceuticals Inc.	Opposition procedure closed
EP03716126A	2013-07-16	Alnylam Pharmaceuticals Inc.	Opposition procedure closed
EP10008930A	2013-05-22	Quark Pharmaceuticals, Inc.	Patent maintained as amended
EP10008930A	2013-05-21	Alnylam Pharmaceuticals Inc.	Patent maintained as amended
EP03743684A	2011-06-01	Alcon Research, Ltd.	Patent maintained as amended
EP03743684A	2011-05-31	Alnylam Pharmaceuticals Inc.	Patent maintained as amended
EP03743684A	2011-05-31	Dharmacon, Inc.	Patent maintained as amended
EP03743684A	2011-05-26	Novartis AG	Patent maintained as amended
EP03743684A	2011-05-18	Sanofi-Aventis Deutschland GmbH	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.
US11078485	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (1 year, 6 months ago)
US8232383	NOVARTIS	RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA)	Feb, 2023 (2 years ago)
US9708610	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Jan, 2024 (1 year, 4 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10266825	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (1 year, 6 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 22, 2026

Drugs and Companies using INCLISIRAN SODIUM ingredient

NCE-1 date: 22 December, 2025

Market Authorisation Date: 22 December, 2021

Treatment: As an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), by inhibiting expression of the pcsk9 gen...

Dosage: SOLUTION

Strength	Dosage	Availability
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION	Prescription

LEQVIO family patents

14. Linzess patent expiration

Application	Filing Date	Opposition Party	Legal Status

EP10170038A	2013-03-26	Generics [UK] Limited	Opposition rejected

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.
US7304036	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Aug, 2026 (1 year, 2 months from now)
US7371727	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (1 year, 4 months ago)
US7704947	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (1 year, 4 months ago)
US7745409	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (1 year, 4 months ago)
US8080526	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (1 year, 4 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8110553	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (1 year, 4 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 30, 2017
New Strength(NS)	Jan 25, 2020
New Indication(I-921)	Jun 12, 2026

Drugs and Companies using LINACLOTIDE ingredient

NCE-1 date: 30 August, 2016

Market Authorisation Date: 25 January, 2017

Treatment: Method of treating chronic idiopathic constipation in adult patients.; Treatment of functional constipation in pediatric patients 6 to 17 years of age

Dosage: CAPSULE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
145 mcg and 290 mcg	30 Aug, 2016	4	09 Feb, 2021	30 Oct, 2031	Deferred
72 mcg	07 Nov, 2017	1		16 Aug, 2033

LINZESS family patents

15. Livmarli patent 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).
US11229647	MIRUM	Methods for treating cholestasis	Feb, 2040 (14 years from now)
US11497745	MIRUM	Methods for treating cholestasis	Feb, 2040 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Mar 13, 2026
New Chemical Entity Exclusivity(NCE)	Sep 29, 2026
New Indication(I-938)	Mar 13, 2027
Orphan Drug Exclusivity(ODE-379)	Sep 29, 2028
Orphan Drug Exclusivity(ODE-429)	Mar 13, 2030
ODE(ODE)	Mar 13, 2031
Orphan Drug Exclusivity(ODE-471)	Mar 13, 2031
Orphan Drug Exclusivity(ODE-490)	Jul 24, 2031

Drugs and Companies using MARALIXIBAT CHLORIDE ingredient

NCE-1 date: 29 September, 2025

Market Authorisation Date: 29 September, 2021

Treatment: Treatment of cholestatic pruritus in patients with alagille syndrome (algs)

Dosage: SOLUTION

LIVMARLI family patents

16. Lorbrena patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8680111	PFIZER	Macrocyclic derivatives for the treatment of diseases	Mar, 2033 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 02, 2023
New Indication(I-847)	Mar 03, 2024
Orphan Drug Exclusivity(ODE-217)	Nov 02, 2025
Orphan Drug Exclusivity(ODE-218)	Nov 02, 2025
Orphan Drug Exclusivity(ODE-219)	Nov 02, 2025
Orphan Drug Exclusivity(ODE-349)	Mar 03, 2028

Drugs and Companies using LORLATINIB ingredient

NCE-1 date: 02 November, 2022

Market Authorisation Date: 02 November, 2018

Treatment: NA

Dosage: TABLET

LORBRENA family patents

17. Mekinist patent 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.
US7378423	NOVARTIS	Pyrimidine compound and medical use thereof	May, 2027 (1 year, 11 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).
US8835443	NOVARTIS	Pyrimidine compound and medical use thereof	Jun, 2025 (10 days from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-678)	Jan 08, 2017
New Chemical Entity Exclusivity(NCE)	May 29, 2018
M(M-170)	Nov 20, 2018
Orphan Drug Exclusivity(ODE)	May 29, 2020
Orphan Drug Exclusivity(ODE-48)	May 29, 2020
New Indication(I-745)	Jun 22, 2020
Orphan Drug Exclusivity(ODE-57)	Jan 08, 2021
New Indication(I-778)	Apr 30, 2021
New Indication(I-781)	May 04, 2021
M(M-246)	Oct 06, 2022
Orphan Drug Exclusivity(ODE-148)	Jun 22, 2024
Orphan Drug Exclusivity(ODE-182)	Apr 30, 2025
Orphan Drug Exclusivity(ODE-183)	May 04, 2025
New Indication(I-895)	Jun 22, 2025
Pediatric Exclusivity(PED)	Sep 16, 2026
New Indication(I-908)	Mar 16, 2026
New Product(NP)	Mar 16, 2026
Orphan Drug Exclusivity(ODE-428)	Mar 16, 2030

Drugs and Companies using TRAMETINIB DIMETHYL SULFOXIDE ingredient

Market Authorisation Date: 16 March, 2023

Treatment: Mekinist is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic thera...

Dosage: SOLUTION

MEKINIST family patents

18. Nuzyra patent 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).
US10383884	PARATEK PHARMS INC	9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)	Oct, 2037 (12 years from now)
US10835542	PARATEK PHARMS INC	9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)	Oct, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 02, 2023
Generating Antibiotic Incentives Now(GAIN)	Oct 02, 2028

Drugs and Companies using OMADACYCLINE TOSYLATE ingredient

NCE-1 date: 03 October, 2027

Market Authorisation Date: 02 October, 2018

Treatment: Treatment of community acquired bacterial pneumonia

Dosage: TABLET; POWDER

NUZYRA family patents

19. Onpattro patent 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.
US8334373	ALNYLAM PHARMS INC	Nuclease resistant double-stranded ribonucleic acid	May, 2025 (3 days ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11141378	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (3 years from now)
US8058069	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (3 years from now)
US8158601	ALNYLAM PHARMS INC	Lipid formulation	Nov, 2030 (5 years from now)
US8492359	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (3 years from now)
US8802644	ALNYLAM PHARMS INC	Lipid formulation	Oct, 2030 (5 years from now)
US8822668	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (3 years from now)
US9364435	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 10, 2023
Orphan Drug Exclusivity(ODE-197)	Aug 10, 2025
M(M-270)	Jan 13, 2026

Drugs and Companies using PATISIRAN SODIUM ingredient

NCE-1 date: 10 August, 2022

Market Authorisation Date: 10 August, 2018

Treatment: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Dosage: SOLUTION

ONPATTRO family patents

20. Orladeyo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11117867	BIOCRYST	Crystalline salts of a plasma kallikrein inhibitor	Nov, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 03, 2025
Orphan Drug Exclusivity(ODE-333)	Dec 03, 2027

Drugs and Companies using BEROTRALSTAT HYDROCHLORIDE ingredient

NCE-1 date: 03 December, 2024

Market Authorisation Date: 03 December, 2020

Treatment: Prophylaxis to prevent attacks of hereditary angioedema (hae) in adults and pediatric patients 12 years of age and older

Dosage: CAPSULE

ORLADEYO family patents

21. Oxlumo patent 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.
US10465195	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (9 years from now)
US10487330	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (9 years from now)
US11060093	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (9 years from now)
US9828606	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (9 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10435692	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-901)	Oct 06, 2025
New Chemical Entity Exclusivity(NCE)	Nov 23, 2025
Orphan Drug Exclusivity(ODE-339)	Nov 23, 2027
Orphan Drug Exclusivity(ODE-415)	Oct 06, 2029

Drugs and Companies using LUMASIRAN SODIUM ingredient

NCE-1 date: 23 November, 2024

Market Authorisation Date: 23 November, 2020

Treatment: Treatment of primary hyperoxaluria type 1 (ph1)

Dosage: SOLUTION

OXLUMO family patents

22. Phexxi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11337989	EVOFEM INC	Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound	Mar, 2033 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 22, 2023

Drugs and Companies using CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE ingredient

Market Authorisation Date: 22 May, 2020

Treatment: Prevention of pregnancy

Dosage: GEL

PHEXXI family patents

23. Pylarify patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8487129	PROGENICS PHARMS INC	Heterodimers of glutamic acid	Nov, 2027 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 26, 2026

Drugs and Companies using PIFLUFOLASTAT F-18 ingredient

NCE-1 date: 26 May, 2025

Market Authorisation Date: 26 May, 2021

Treatment: NA

Dosage: SOLUTION

PYLARIFY family patents

24. Qinlock patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8188113	DECIPHERA PHARMS	Dihydropyridopyrimidinyl, dihydronaphthyidinyl and related compounds useful as kinase inhibitors for the treatment of proliferative diseases	Jul, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 15, 2025
Orphan Drug Exclusivity(ODE-298)	May 15, 2027

Drugs and Companies using RIPRETINIB ingredient

NCE-1 date: 15 May, 2024

Market Authorisation Date: 15 May, 2020

Treatment: NA

Dosage: TABLET

QINLOCK family patents

25. Recarbrio patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8487093	MSD MERCK CO	β-lactamase inhibitors	Mar, 2033 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 16, 2024
Generating Antibiotic Incentives Now(GAIN)	Jul 16, 2029

Drugs and Companies using CILASTATIN SODIUM; IMIPENEM; RELEBACTAM ingredient

NCE-1 date: 16 July, 2028

Market Authorisation Date: 16 July, 2019

Treatment: Treatment of complicated urinary tract infections, including pyelonephritis (cuti)

Dosage: POWDER

RECARBRIO family patents

26. Seysara patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9255068	ALMIRALL	Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(methyl)amino)-methyl] acid amide and methods of using the same	Feb, 2033 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 01, 2023

Drugs and Companies using SARECYCLINE HYDROCHLORIDE ingredient

NCE-1 date: 01 October, 2022

Market Authorisation Date: 01 October, 2018

Treatment: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydroch...

Dosage: TABLET

SEYSARA family patents

27. Signifor Lar Kit patent 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.
US7473761	RECORDATI RARE	Somatostatin analogues	Dec, 2026 (1 year, 6 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).
US8822637	RECORDATI RARE	Somatostatin analogues	Aug, 2023 (1 year, 9 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 14, 2017
New Product(NP)	Dec 15, 2017
New Indication(I-785)	Jun 29, 2021
Orphan Drug Exclusivity(ODE)	Dec 15, 2021
Orphan Drug Exclusivity(ODE-81)	Dec 15, 2021
Orphan Drug Exclusivity(ODE-268)	Jun 29, 2025

Drugs and Companies using PASIREOTIDE PAMOATE ingredient

NCE-1 date: 14 December, 2016

Market Authorisation Date: 29 June, 2018

Treatment: Method of treating acromegaly

Dosage: FOR SUSPENSION

SIGNIFOR LAR KIT family patents

28. Slynd patent 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).
US10179140	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)
US10603281	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)
US10849857	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)
US11123299	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11291632	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11291633	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11413249	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11439598	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US11504334	EXELTIS USA INC	Synthetic progestogens and pharmaceutical compositions comprising the same	Jun, 2031 (6 years from now)
US9603860	EXELTIS USA INC	Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same	Jun, 2031 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 23, 2022

Drugs and Companies using DROSPIRENONE ingredient

Market Authorisation Date: 23 May, 2019

Treatment: Prevention of pregnancy in females of reproductive age

Dosage: TABLET

SLYND family patents

29. Tafinlar patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8835443	NOVARTIS	Pyrimidine compound and medical use thereof	Jun, 2025 (10 days from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-678)	Jan 08, 2017
New Chemical Entity Exclusivity(NCE)	May 29, 2018
M(M-170)	Nov 20, 2018
Orphan Drug Exclusivity(ODE)	May 29, 2020
Orphan Drug Exclusivity(ODE-47)	May 29, 2020
New Indication(I-745)	Jun 22, 2020
Orphan Drug Exclusivity(ODE-58)	Jan 09, 2021
New Indication(I-778)	Apr 30, 2021
New Indication(I-781)	May 04, 2021
M(M-246)	Oct 06, 2022
Orphan Drug Exclusivity(ODE-147)	Jun 22, 2024
Orphan Drug Exclusivity(ODE-182)	Apr 30, 2025
Orphan Drug Exclusivity(ODE-183)	May 04, 2025
New Indication(I-894)	Jun 22, 2025
Pediatric Exclusivity(PED)	Sep 16, 2026
New Indication(I-908)	Mar 16, 2026
New Product(NP)	Mar 16, 2026
Orphan Drug Exclusivity(ODE-428)	Mar 16, 2030

Drugs and Companies using DABRAFENIB MESYLATE ingredient

Market Authorisation Date: 16 March, 2023

Treatment: Tafinlar is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic thera...

Dosage: TABLET, FOR SUSPENSION

TAFINLAR family patents

30. Tibsovo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10653710	SERVIER	Combination therapy for treating malignancies	Oct, 2036 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-816)	May 02, 2022
New Chemical Entity Exclusivity(NCE)	Jul 20, 2023
New Indication(I-875)	Aug 25, 2024
New Indication(I-893)	May 25, 2025
Orphan Drug Exclusivity(ODE-203)	Jul 20, 2025
Orphan Drug Exclusivity(ODE-242)	May 02, 2026
New Indication(I-924)	Oct 24, 2026
Orphan Drug Exclusivity(ODE-368)	Aug 25, 2028
Orphan Drug Exclusivity(ODE-447)	Oct 24, 2030

Drugs and Companies using IVOSIDENIB ingredient

NCE-1 date: 20 July, 2022

Market Authorisation Date: 20 July, 2018

Treatment: A method for treating newly diagnosed aml characterized by the presence of a mutant allele of idh1 selected from r132h, r132c, r132l, r132v, r132s and r132gf by administering ivosidenib and azacitidin...

Dosage: TABLET

TIBSOVO family patents

31. Tigecycline patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9855335	AMNEAL	Tigecycline composition for injection	Apr, 2033 (7 years from now)

Drugs and Companies using TIGECYCLINE ingredient

Market Authorisation Date: 02 August, 2018

Treatment: NA

Dosage: POWDER

TIGECYCLINE family patents

32. Twyneo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10420743	GALDERMA LABS LP	Methods and compositions for the treatment of acne	Jul, 2038 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Combination(NC)	Jul 26, 2024

Drugs and Companies using BENZOYL PEROXIDE; TRETINOIN ingredient

Market Authorisation Date: 26 July, 2021

Treatment: Topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older

Dosage: CREAM

TWYNEO family patents

33. Verkazia patent 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).
US7973081	HARROW EYE	Emulsion compositions containing quaternary ammonium compounds	Jan, 2026 (7 months from now)
US8524779	HARROW EYE	Emulsion compositions containing quaternary ammonium compounds	Jan, 2026 (7 months from now)
US9132071	HARROW EYE	Compositions containing quaternary ammonium compounds	Jun, 2029 (4 years from now)
US9220694	HARROW EYE	Emulsion compositions containing cetalkonium chloride	Jan, 2026 (7 months from now)
US9956289	HARROW EYE	Emulsion compositions containing quaternary ammonium compounds	Jan, 2026 (7 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jun 23, 2024
Orphan Drug Exclusivity(ODE-358)	Jun 23, 2028

Drugs and Companies using CYCLOSPORINE ingredient

Market Authorisation Date: 23 June, 2021

Treatment: NA

Dosage: EMULSION

VERKAZIA family patents

34. Welireg patent 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.
US9908845	MERCK SHARP DOHME	Aryl ethers and uses thereof	Sep, 2034 (9 years from now)
US9969689	MERCK SHARP DOHME	Aryl ethers and uses thereof	Sep, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 13, 2026
New Indication(I-931)	Dec 14, 2026
Orphan Drug Exclusivity(ODE-364)	Aug 13, 2028

Drugs and Companies using BELZUTIFAN ingredient

NCE-1 date: 13 August, 2025

Market Authorisation Date: 13 August, 2021

Treatment: Treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand inhibitor and a vascular endothelial growth factor tyrosine kinase inh...

Dosage: TABLET

WELIREG family patents

35. Xyosted (autoinjector) patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11160751	ANTARES PHARMA INC	Hematocrit modulation through needle assisted jet injection of testosterone	Oct, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Sep 28, 2021

Drugs and Companies using TESTOSTERONE ENANTHATE ingredient

Market Authorisation Date: 28 September, 2018

Treatment: Method of administering testosterone enanthate subcutaneously

Dosage: SOLUTION

XYOSTED (AUTOINJECTOR) family patents

36. Zeposia patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10239846	BRISTOL	Selective sphingosine 1 phosphate receptor modulators and methods of chiral synthesis	Nov, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-860)	May 27, 2024
New Chemical Entity Exclusivity(NCE)	Mar 25, 2025
M(M-309)	Aug 30, 2027

Drugs and Companies using OZANIMOD HYDROCHLORIDE ingredient

NCE-1 date: 25 March, 2024

Market Authorisation Date: 25 March, 2020

Treatment: Treatment of moderately to severely active ulcerative colitis (uc) in adults

Dosage: CAPSULE

ZEPOSIA family patents

37. Zilxi patent 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).
US10213512	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)
US10265404	JOURNEY	Compositions, gels and foams with rheology modulators and uses thereof	Oct, 2030 (5 years from now)
US10322186	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)
US10946101	JOURNEY	Surfactant-free water-free foamable compositions, breakable foams and gels and their uses	Oct, 2030 (5 years from now)
US8945516	JOURNEY	Surfactant-free water-free foamable compositions, breakable foams and gels and their uses	Oct, 2030 (5 years from now)
US8992896	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)
US9675700	JOURNEY	Topical tetracycline compositions	Oct, 2030 (5 years from now)

Drugs and Companies using MINOCYCLINE HYDROCHLORIDE ingredient

Market Authorisation Date: 28 May, 2020

Treatment: Treatment of inflammatory lesions of rosacea

Dosage: AEROSOL, FOAM

ZILXI family patents

38. Zulresso patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10251894	SAGE THERAP	Anticonvulsant activity of steroids	Nov, 2033 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 17, 2024
New Patient Population(NPP)	Jun 16, 2025

Drugs and Companies using BREXANOLONE ingredient

NCE-1 date: 18 June, 2023

Market Authorisation Date: 17 June, 2019

Treatment: Method of treating postpartum depression

Dosage: SOLUTION

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8058069	January, 2019	Final Written Decision	Arbutus Biopharma Corporation	Moderna Therapeutics, Inc.
US9364435	March, 2018	FWD Entered	Arbutus Biopharma Corporation	Moderna Therapeutics, Inc.

Strength	Dosage	Availability
145MCG	CAPSULE	Prescription
290MCG	CAPSULE	Prescription
72MCG	CAPSULE	Prescription

Strength	Dosage	Availability
EQ 150MG BASE	TABLET	Prescription
EQ 100MG BASE/VIAL	POWDER	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP09731866A	2018-04-05	Merck Sharp & Dohme Corporation	Granted and Under Opposition
EP09731866A	2018-04-05	Moderna Therapeutics, Inc.	Granted and Under Opposition

Strength	Dosage	Availability
EQ 110MG BASE	CAPSULE	Prescription
EQ 150MG BASE	CAPSULE	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP19214298A	2023-01-10	Telix Innovations S.A.	Granted and Under Opposition
EP18150494A	2021-09-30	Deutsches Krebsforschungszentrum - Stiftung des öffentlichen Rechts / Universität Heidelberg	Revoked
EP18150494A	2021-09-30	POLSERVICE KANCELARIA RZECZNIKOW PATENTOWYCH SP. Z O.O.	Revoked
EP18150494A	2021-09-23	Lewis Silkin LLP	Revoked

Strength	Dosage	Availability
EQ 60MG BASE	TABLET	Prescription
EQ 100MG BASE	TABLET	Prescription
EQ 150MG BASE	TABLET	Prescription

Strength	Dosage	Availability
EQ 20MG BASE/VIAL	FOR SUSPENSION	Prescription
EQ 40MG BASE/VIAL	FOR SUSPENSION	Prescription
EQ 60MG BASE/VIAL	FOR SUSPENSION	Prescription
EQ 10MG BASE/VIAL	FOR SUSPENSION	Prescription
EQ 30MG BASE/VIAL	FOR SUSPENSION	Prescription

Strength	Dosage	Availability
50MG/0.5ML (50MG/0.5ML)	SOLUTION	Prescription
75MG/0.5ML (75MG/0.5ML)	SOLUTION	Prescription
100MG/0.5ML (100MG/0.5ML)	SOLUTION	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP10830880A	2018-12-14	Generics [UK] Ltd	Granted and Under Opposition

Strength	Dosage	Availability
EQ 0.23MG BASE	CAPSULE	Prescription
EQ 0.46MG BASE	CAPSULE	Prescription
EQ 0.92MG BASE	CAPSULE	Prescription

Pharsight

Pharsight

Drugs with SPC(s)

1. Amzeeq patent expiration

AMZEEQ family patents

2. Auvelity patent expiration

AUVELITY family patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years. Get the exclusive patent insights now. Don't be the last to know. Download Report 3. Caplyta patent expiration

CAPLYTA family patents

4. Copiktra patent expiration

COPIKTRA family patents

5. Drospirenone patent expiration

DROSPIRENONE family patents

6. Duzallo patent expiration

DUZALLO family patents

7. Ezallor Sprinkle patent expiration

EZALLOR SPRINKLE family patents

8. Fleqsuvy patent expiration

FLEQSUVY family patents

9. Galafold patent expiration

GALAFOLD family patents

10. Givlaari patent expiration

GIVLAARI family patents

11. Gocovri patent expiration

GOCOVRI family patents

12. Kloxxado patent expiration

KLOXXADO family patents

13. Leqvio patent expiration

LEQVIO family patents

14. Linzess patent expiration

LINZESS family patents

15. Livmarli patent expiration

LIVMARLI family patents

16. Lorbrena patent expiration

LORBRENA family patents

17. Mekinist patent expiration

MEKINIST family patents

18. Nuzyra patent expiration

NUZYRA family patents

19. Onpattro patent expiration

ONPATTRO family patents

20. Orladeyo patent expiration

ORLADEYO family patents

21. Oxlumo patent expiration

OXLUMO family patents

22. Phexxi patent expiration

PHEXXI family patents

23. Pylarify patent expiration

PYLARIFY family patents

24. Qinlock patent expiration

QINLOCK family patents

25. Recarbrio patent expiration

RECARBRIO family patents

26. Seysara patent expiration

SEYSARA family patents

27. Signifor Lar Kit patent expiration

SIGNIFOR LAR KIT family patents

28. Slynd patent expiration

SLYND family patents

29. Tafinlar patent expiration

TAFINLAR family patents

30. Tibsovo patent expiration

TIBSOVO family patents

31. Tigecycline patent expiration

TIGECYCLINE family patents

32. Twyneo patent expiration

TWYNEO family patents

33. Verkazia patent expiration

VERKAZIA family patents

34. Welireg patent expiration

WELIREG family patents

35. Xyosted (autoinjector) patent expiration

XYOSTED (AUTOINJECTOR) family patents

36. Zeposia patent expiration

ZEPOSIA family patents

37. Zilxi patent expiration

ZILXI family patents

38. Zulresso patent expiration

ZULRESSO family patents

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Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

3. Caplyta patent expiration