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).
US6620435	ALMIRALL	Compositions for topical application of therapeutic agents	Sep, 2016 (7 years ago)
US6060085	ALMIRALL	Compositions and methods for topical application of therapeutic agents	Sep, 2016 (7 years ago)
US5863560	ALMIRALL	Compositions and methods for topical application of therapeutic agents	Sep, 2016 (7 years ago)
US9517219	ALMIRALL	Topical dapsone and dapsone/adapalene compositions and methods for use thereof	Nov, 2033 (9 years from now)
US9161926	ALMIRALL	Topical dapsone and dapsone/adaplene compositions and methods for use thereof	Nov, 2033 (9 years from now)
US11273132	ALMIRALL	Topical dapsone and dapsone/adapalene compositions and methods for use thereof	Nov, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Strength(NS)	Feb 24, 2019
New Patient Population(NPP)	Sep 10, 2022

Drugs and Companies using DAPSONE ingredient

Market Authorisation Date: 24 February, 2016

Treatment: Treatment of acne; 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.
USRE43390	ALMIRALL	Pleuromutilin derivatives as antimicrobials	Apr, 2021 (3 years ago)
USRE39128	ALMIRALL	Pleuromutilin derivatives as antimicrobials	Apr, 2021 (3 years ago)
US7875630	ALMIRALL	Process salts compositions and use	Feb, 2027 (2 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 (4 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 12, 2012

Drugs and Companies using RETAPAMULIN ingredient

NCE-1 date: 13 April, 2011

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 (1 year, 8 months from now)
US8236799	ALMIRALL	Biaryl compositions and methods for modulating a kinase cascade	Dec, 2025 (1 year, 8 months from now)
US7300931	ALMIRALL	Compositions for treating cell proliferation disorders	Feb, 2026 (1 year, 9 months from now)
US7851470	ALMIRALL	Composition and methods for modulating a kinase cascade	Feb, 2029 (4 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 (3 years from now)
US11497750	ALMIRALL	Methods of treating and/or preventing actinic keratosis	Mar, 2038 (13 years from now)
US10617693	ALMIRALL	Methods of treating and/or preventing actinic keratosis	Mar, 2038 (13 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: 14 December, 2024

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 (8 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 (5 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 sarecycline hydrochloride in 60 mg, 100 mg...

Dosage: TABLET;ORAL

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

SEYSARA family patents

5. Solage 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).
US5194247	ALMIRALL	Synergistic skin depigmentation composition	Dec, 2013 (10 years ago)
US6353029	ALMIRALL	Storage stable tretinoin and 4-hydroxyanisole containing topical composition	Aug, 2020 (3 years ago)

Drugs and Companies using MEQUINOL; TRETINOIN ingredient

Market Authorisation Date: 10 December, 1999

Treatment: Treatment of hyperpigmentary disorders

Dosage: SOLUTION;TOPICAL

Strength	Dosage	Availability
2%;0.01%	SOLUTION;TOPICAL	Discontinued

SOLAGE family patents

6. Veltin 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).
US5690923	ALMIRALL	Stable topical retinoid compositions	Nov, 2014 (9 years ago)
US9492384	ALMIRALL	Microemulsion and sub-micron emulsion process and compositions	Aug, 2025 (1 year, 4 months from now)

Drugs and Companies using CLINDAMYCIN PHOSPHATE; TRETINOIN ingredient

Market Authorisation Date: 16 July, 2010

Treatment: Treatment of atopic dermatitis

Dosage: GEL;TOPICAL

Strength	Dosage	Availability
1.2%;0.025%	GEL;TOPICAL	Prescription

VELTIN family patents

7. 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).
US6730288	ALMIRALL	Mousse composition	Sep, 2019 (4 years ago)
US7029659	ALMIRALL	Mousse composition	Sep, 2019 (4 years ago)
US9492384	ALMIRALL	Microemulsion and sub-micron emulsion process and compositions	Aug, 2025 (1 year, 4 months from now)
US8962000	ALMIRALL	Microemulsion and sub-micron emulsion process and compositions	Aug, 2025 (1 year, 4 months from now)
US8460641	ALMIRALL	Microemulsion process and composition	Aug, 2027 (3 years from now)

Drugs and Companies using DESONIDE ingredient

Market Authorisation Date: 19 September, 2006

Treatment: Treatment of atopic dermatitis

Dosage: AEROSOL, FOAM;TOPICAL

Strength	Dosage	Availability
0.05%	AEROSOL, FOAM;TOPICAL	Discontinued

VERDESO family patents

8. Xolegel 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).
US8735393	ALMIRALL	Anhydrous topical skin preparations	Dec, 2018 (5 years ago)
US7179475	ALMIRALL	Anhydrous topical skin preparations	Dec, 2018 (5 years ago)
US8232276	ALMIRALL	Anhydrous topical skin preparations	Nov, 2020 (3 years ago)

Drugs and Companies using KETOCONAZOLE ingredient

Market Authorisation Date: 28 July, 2006

Treatment: Treatment of seborrhea dermatitis in humans

Dosage: GEL;TOPICAL

Pharsight

Almirall patents expiration

1. Aczone patents expiration

ACZONE family patents

2. Altabax patents expiration

ALTABAX family patents

3. Klisyri patents expiration

KLISYRI family patents

4. Seysara patents expiration

SEYSARA family patents

5. Solage patents expiration

SOLAGE family patents

6. Veltin patents expiration

VELTIN family patents

7. Verdeso patents expiration

VERDESO family patents

8. Xolegel patents expiration

XOLEGEL family patents

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