Pharsight

1. Aczone patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9517219	June, 2019	FWD Entered	Almirall, LLC	Mylan Pharmaceuticals Inc.
US9517219	November, 2018	FWD Entered	Almirall, LLC	Amneal Pharmaceuticals LLC
US9161926	February, 2018	FWD Entered	Almirall, LLC	Amneal Pharmceuticals LLC

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).
US9161926	ALMIRALL	Topical dapsone and dapsone/adaplene compositions and methods for use thereof	Nov, 2033 (10 years from now)
US9517219	ALMIRALL	Topical dapsone and dapsone/adapalene compositions and methods for use thereof	Nov, 2033 (10 years from now)
US11273132	ALMIRALL	Topical dapsone and dapsone/adapalene compositions and methods for use thereof	Nov, 2033 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population (NPP)	Sep 10, 2022

Drugs and Companies using DAPSONE ingredient

Market Authorisation Date: 24 February, 2016

Treatment: Topical treatment of acne vulgaris

Dosage: GEL;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.075	13 Feb, 2017	1	26 Jun, 2019	18 Nov, 2033	Eligible

Strength	Dosage	Availability
7.5%	GEL;TOPICAL	Prescription

ACZONE family patents

2. Altabax 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.
US7875630	ALMIRALL	Process salts compositions and use	Feb, 2027 (3 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).
US8207191	ALMIRALL	Process, salts, composition and use	Aug, 2024 (11 months from now)

Drugs and Companies using RETAPAMULIN ingredient

Market Authorisation Date: 12 April, 2007

Treatment: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes

Dosage: OINTMENT;TOPICAL

Strength	Dosage	Availability
1%	OINTMENT;TOPICAL	Prescription

ALTABAX family patents

3. Klisyri 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.
US8980890	ALMIRALL	Compositions and methods of treating cell proliferation disorders	Dec, 2025 (2 years from now)
US8236799	ALMIRALL	Biaryl compositions and methods for modulating a kinase cascade	Dec, 2025 (2 years from now)
US7300931	ALMIRALL	Compositions for treating cell proliferation disorders	Feb, 2026 (2 years from now)
US7851470	ALMIRALL	Composition and methods for modulating a kinase cascade	Feb, 2029 (5 years from now)
US10669236	ALMIRALL	Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide	Sep, 2038 (14 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).
US10323001	ALMIRALL	Compositions for modulating a kinase cascade and methods of use thereof	Dec, 2027 (4 years from now)
US11497750	ALMIRALL	Methods of treating and/or preventing actinic keratosis	Mar, 2038 (14 years from now)
US10617693	ALMIRALL	Methods of treating and/or preventing actinic keratosis	Mar, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Dec 14, 2025

Drugs and Companies using TIRBANIBULIN ingredient

NCE-1 date: 2024-12-14

Market Authorisation Date: 14 December, 2020

Treatment: Topical treatment of actinic keratosis of the face or scalp

Dosage: OINTMENT;TOPICAL

Strength	Dosage	Availability
1%	OINTMENT;TOPICAL	Prescription

KLISYRI family patents

4. Seysara 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.
US8318706	ALMIRALL	Substituted tetracycline compounds	May, 2031 (7 years from now)
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 (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).
US9481639	ALMIRALL	Substituted tetracycline compounds for treatment of inflammatory skin disorders	Aug, 2028 (4 years from now)
US8513223	ALMIRALL	Substituted tetracycline compounds for treatment of inflammatory skin disorders	Dec, 2029 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 1, 2023

Drugs and Companies using SARECYCLINE HYDROCHLORIDE ingredient

NCE-1 date: 2022-10-01

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 sarecycline hydrochloride in 60 mg, 100 mg...

Dosage: TABLET;ORAL

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

SEYSARA family patents

5. Verdeso patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP05775966A	2014-05-14	Henkel AG & Co. KGaA	Patent maintained as amended
EP05775966A	2014-05-14	Generics [UK] Limited	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).
US9492384	ALMIRALL	Microemulsion and sub-micron emulsion process and compositions	Aug, 2025 (1 year, 11 months from now)
US8962000	ALMIRALL	Microemulsion and sub-micron emulsion process and compositions	Aug, 2025 (1 year, 11 months from now)
US8460641	ALMIRALL	Microemulsion process and composition	Aug, 2027 (3 years from now)