Pharsight

1. Aklief patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP13726504A	2019-04-24	Generics (U.K.) Limited	Patent maintained as amended
EP13728696A	2019-03-26	Generics (UK) 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.
US7807708	GALDERMA LABS LP	Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof	Jul, 2031 (7 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).
US8227507	GALDERMA LABS LP	Ligands that modulate RAR receptors	Dec, 2025 (1 year, 7 months from now)
US8470871	GALDERMA LABS LP	Ligands that modulate RAR receptors	Dec, 2025 (1 year, 7 months from now)
US9084778	GALDERMA LABS LP	Topical compositions containing a retinoid of the oil-in-water emulsion type	May, 2033 (9 years from now)
US9498465	GALDERMA LABS LP	Topical compositions in the form of a gel containing a particular solubilized retinoid	May, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 04, 2024

Drugs and Companies using TRIFAROTENE ingredient

NCE-1 date: 05 October, 2023

Market Authorisation Date: 04 October, 2019

Treatment: Topical treatment of acne vulgaris; Method of activating rargamma receptor; Treatment of acne vulgaris

Dosage: CREAM;TOPICAL

Strength	Dosage	Availability
0.005%	CREAM;TOPICAL	Prescription

AKLIEF family patents

2. Clobex 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).
US6106848	GALDERMA LABS LP	Topically applicable O/W emulsions having high glycol content and at least one biologically active agent	Sep, 2017 (6 years ago)
US5972920	GALDERMA LABS LP	Formulation containing a carrier, active ingredient, and surfactant for treating skin disorders	Feb, 2018 (6 years ago)
US5990100	GALDERMA LABS LP	Composition and method for treatment of psoriasis	Mar, 2018 (6 years ago)

Drugs and Companies using CLOBETASOL PROPIONATE ingredient

Market Authorisation Date: 24 July, 2003

Treatment: Twice daily topical treatment of moderate to severe plaque psoriasis.

Dosage: SPRAY;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.0005	27 Mar, 2006	1	04 Dec, 2008	22 Sep, 2017	Eligible
0.0005	29 Sep, 2008	1	16 Jun, 2011	24 Mar, 2018	Eligible
0.0005	09 Jan, 2008	1	07 Jun, 2011	17 Jun, 2019	Non-Forfeiture

Strength	Dosage	Availability
0.05%	SPRAY;TOPICAL	Prescription

CLOBEX family patents

3. Differin 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).
US7868044	GALDERMA LABS LP	Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid	Mar, 2023 (1 year, 1 month ago)
US7834060	GALDERMA LABS LP	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders	Mar, 2023 (1 year, 1 month ago)
US7838558	GALDERMA LABS LP	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders	Mar, 2023 (1 year, 1 month ago)
US8703820	GALDERMA LABS LP	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders	Mar, 2023 (1 year, 1 month ago)
US7737181	GALDERMA LABS LP	Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders	Aug, 2024 (4 months from now)
US7579377	GALDERMA LABS LP	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders	Feb, 2025 (9 months from now)
US8709392	GALDERMA LABS LP	Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers	Sep, 2026 (2 years from now)
US8435502	GALDERMA LABS LP	Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers	Sep, 2026 (2 years from now)
US7998467	GALDERMA LABS LP	Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers	May, 2028 (4 years from now)

Drugs and Companies using ADAPALENE ingredient

Market Authorisation Date: 19 June, 2007

Treatment: Treatment of acne; Topical treatment of acne vulgaris

Dosage: GEL;TOPICAL; LOTION;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.003	15 Sep, 2009	1	14 Jun, 2012	23 Feb, 2025	Eligible

Strength	Dosage	Availability
0.3%	GEL;TOPICAL	Prescription
0.1%	LOTION;TOPICAL	Prescription

DIFFERIN family patents

4. Epiduo patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP08708470A	2016-03-10	Generics (U.K.) Limited	Revoked
EP07787478A	2014-03-05	Generics [UK] Limited	Opposition rejected

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).
US8809305	GALDERMA LABS LP	Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris	Dec, 2022 (1 year, 4 months ago)
US8241649	GALDERMA LABS LP	Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide	Dec, 2022 (1 year, 4 months ago)
US8105618	GALDERMA LABS LP	Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide	Dec, 2022 (1 year, 4 months ago)
US8936800	GALDERMA LABS LP	Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt	Dec, 2022 (1 year, 4 months ago)
US7964202	GALDERMA LABS LP	Method for treatment of common acne	Sep, 2024 (4 months from now)
US7820186	GALDERMA LABS LP	Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt	Nov, 2025 (1 year, 6 months from now)
US8445543	GALDERMA LABS LP	Combinations of adapalene and benzoyl peroxide for treating acne lesions	Jul, 2027 (3 years from now)
US8071644	GALDERMA LABS LP	Combinations of adapalene and benzoyl peroxide for treating acne lesions	Jul, 2027 (3 years from now)
US8129362	GALDERMA LABS LP	Combination/association of adapalene and benzoyl peroxide for treating acne lesions	Jul, 2027 (3 years from now)
US8080537	GALDERMA LABS LP	Combinations of adapalene and benzoyl peroxide for treating acne lesions	Jul, 2027 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Combination(NC)	Dec 08, 2011
New Patient Population(NPP)	Feb 01, 2016

Drugs and Companies using ADAPALENE; BENZOYL PEROXIDE ingredient

Market Authorisation Date: 08 December, 2008

Treatment: Treatment of acne

Dosage: GEL;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.1%/2.5%	30 Dec, 2011	1	30 Sep, 2015	18 Jul, 2027	Eligible

Strength	Dosage	Availability
0.1%;2.5%	GEL;TOPICAL	Prescription

EPIDUO family patents

5. Epsolay 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).
US9868103	GALDERMA LABS LP	Metal oxide coating of water insoluble ingredients	Aug, 2028 (4 years from now)
US9687465	GALDERMA LABS LP	Compositions for the treatment of rosacea	Nov, 2032 (8 years from now)
US10945987	GALDERMA LABS LP	Method for providing early onset of action in the treatment of rosacea	Feb, 2040 (15 years from now)
US11541026	GALDERMA LABS LP	Method for treatment of rosacea	Feb, 2040 (15 years from now)
US10933046	GALDERMA LABS LP	Method for treatment of rosacea in patients aged 65 years and older	Feb, 2040 (15 years from now)
US11426378	GALDERMA LABS LP	Method for long-term treatment of rosacea	Aug, 2040 (16 years from now)
US11628155	GALDERMA LABS LP	Method for therapeutic treatment of rosacea	Dec, 2040 (16 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Apr 22, 2025

Drugs and Companies using BENZOYL PEROXIDE ingredient

Market Authorisation Date: 22 April, 2022

Treatment: Topical treatment of inflammatory lesions of rosacea in adults 18 years of age and older; Topical treatment of inflammatory lesions of rosacea in adults 65 years of age and older

Dosage: CREAM;TOPICAL

Strength	Dosage	Availability
5%	CREAM;TOPICAL	Prescription

EPSOLAY family patents

6. Metrogel 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).
US7348317	GALDERMA LABS LP	Aqueous compositions containing metronidazole	Feb, 2022 (2 years ago)
US6881726	GALDERMA LABS LP	Aqueous compositions containing metronidazole	Feb, 2022 (2 years ago)

Drugs and Companies using METRONIDAZOLE ingredient

Market Authorisation Date: 30 June, 2005

Treatment: Once a day topical treatment of the inflammatory lesions of rosacea

Dosage: GEL;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.01	21 Oct, 2008	1	22 Jul, 2011	21 Feb, 2022	Eligible

Strength	Dosage	Availability
1%	GEL;TOPICAL	Prescription

METROGEL family patents

7. Metvixia patents 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).
US6034267	GALDERMA LABS LP	Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy	Mar, 2016 (8 years ago)

Drugs and Companies using METHYL AMINOLEVULINATE HYDROCHLORIDE ingredient

Market Authorisation Date: 27 July, 2004

Treatment: Treatment of actinic keratoses by photodynamic therapy

Dosage: CREAM;TOPICAL

Strength	Dosage	Availability
EQ 16.8% BASE	CREAM;TOPICAL	Discontinued

METVIXIA family patents

8. Mirvaso patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11185810A	2015-04-16	Beiersdorf AG	Patent maintained as amended
EP04753601A	2012-07-26	ALLERGAN, INC.	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent

US7439241	May, 2014	Decision	Jack Dejovin et al
US8426410	May, 2014	Decision	Jack Dejovin et al

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).
US8859551	GALDERMA LABS LP	Compounds, formulations, and methods for treating or preventing inflammatory skin disorders	May, 2024 (27 days from now)
US8410102	GALDERMA LABS LP	Methods and compositions for treating or preventing erythema	May, 2025 (1 year, 26 days from now)
US8426410	GALDERMA LABS LP	Compounds, formulations, and methods for treating or preventing inflammatory skin disorders	May, 2025 (1 year, 26 days from now)
US8231885	GALDERMA LABS LP	Compounds, formulations, and methods for ameliorating telangiectasis	May, 2025 (1 year, 26 days from now)
US7439241	GALDERMA LABS LP	Compounds, formulations, and methods for treating or preventing rosacea	Aug, 2025 (1 year, 3 months from now)
US8513249	GALDERMA LABS LP	Methods and compositions for safe and effective treatment of erythema	Mar, 2031 (6 years from now)
US8513247	GALDERMA LABS LP	Methods and compositions for safe and effective treatment of erythema	Mar, 2031 (6 years from now)
US9861631	GALDERMA LABS LP	Methods and compositions for safe and effective treatment of erythema	Mar, 2031 (6 years from now)
US9861632	GALDERMA LABS LP	Methods and compositions for safe and effective treatment of erythema	Mar, 2031 (6 years from now)
US10201517	GALDERMA LABS LP	Brimonidine gel compositions and methods of use	Jun, 2031 (7 years from now)
US8053427	GALDERMA LABS LP	Brimonidine gel composition	Jun, 2031 (7 years from now)
US8163725	GALDERMA LABS LP	Gel compositions and methods of use	Jun, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosage Form(NDF)	Aug 23, 2016

Drugs and Companies using BRIMONIDINE TARTRATE ingredient

Market Authorisation Date: 23 August, 2013

Treatment: Topical treatment of facial erythema of rosacea

Dosage: GEL;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.0033	15 Dec, 2014	1		13 Jun, 2031	Extinguished

Strength	Dosage	Availability
EQ 0.33% BASE	GEL;TOPICAL	Prescription

MIRVASO family patents

9. Oracea patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8603506	August, 2015	Terminated-Denied	GALDERMA LABORATORIES, INC.	Dr. Reddy’s Laboratories, Ltd.
US8206740	June, 2013	FWD Entered
US8394406	June, 2013	FWD Entered
US8394405	June, 2013	FWD Entered	Supernus Pharmaceuticals, Inc.	Amneal Pharamceuticals, 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).
US5919775	GALDERMA LABS LP	Method for inhibiting expression of inducible nitric oxide synthase with tetracycline	Aug, 2016 (7 years ago)
US5789395	GALDERMA LABS LP	Method of using tetracycline compounds for inhibition of endogenous nitric oxide production	Aug, 2016 (7 years ago)
US8603506	GALDERMA LABS LP	Methods of treating acne	Apr, 2022 (2 years ago)
US10058564	GALDERMA LABS LP	Methods of treating acne	Apr, 2022 (2 years ago)
US9241946	GALDERMA LABS LP	Methods of treating acne	Apr, 2022 (2 years ago)
US7232572	GALDERMA LABS LP	Methods of treating rosacea	Apr, 2022 (2 years ago)
US7211267	GALDERMA LABS LP	Methods of treating acne	Apr, 2022 (2 years ago)
US8394406	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (20 days ago)
US8709478	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (20 days ago)
US8394405	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (20 days ago)
US8470364	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (20 days ago)
US8206740	GALDERMA LABS LP	Once daily formulations of tetracyclines	Dec, 2025 (1 year, 7 months from now)
US7749532	GALDERMA LABS LP	Once daily formulations of tetracyclines	Dec, 2027 (3 years from now)

Drugs and Companies using DOXYCYCLINE ingredient

Market Authorisation Date: 26 May, 2006

Treatment: Treatment of only inflammatory lesions (papules and pustules) of rosacea

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
40 mg	12 Dec, 2008	1		05 Apr, 2022	Extinguished

Strength	Dosage	Availability
40MG	CAPSULE;ORAL	Prescription

ORACEA family patents

10. Soolantra 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).
US5952372	GALDERMA LABS LP	Method for treating rosacea using oral or topical ivermectin	Sep, 2018 (5 years ago)
US6133310	GALDERMA LABS LP	Method of treatment of rosacea	Apr, 2019 (5 years ago)
US8815816	GALDERMA LABS LP	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	Apr, 2024 (5 days ago)
US8093219	GALDERMA LABS LP	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	Apr, 2024 (5 days ago)
US8080530	GALDERMA LABS LP	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	Apr, 2024 (5 days ago)
US8415311	GALDERMA LABS LP	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	Apr, 2024 (5 days ago)
US11033565	GALDERMA LABS LP	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	Apr, 2024 (5 days ago)
US7550440	GALDERMA LABS LP	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	Apr, 2024 (5 days ago)
US8470788	GALDERMA LABS LP	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	Apr, 2024 (5 days ago)
US9233117	GALDERMA LABS LP	Treatment of inflammatory lesions of rosacea with ivermectin	Mar, 2034 (9 years from now)
US9233118	GALDERMA LABS LP	Treatment of papulopustular rosacea with ivermectin	Mar, 2034 (9 years from now)
US9089587	GALDERMA LABS LP	Treatment of papulopustular rosacea with ivermectin	Mar, 2034 (9 years from now)
US10206939	GALDERMA LABS LP	Treatment of papulopustular rosacea with ivermectin	Mar, 2034 (9 years from now)
US9782425	GALDERMA LABS LP	Treatment of papulopustular rosacea with ivermectin	Mar, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 19, 2017

Drugs and Companies using IVERMECTIN ingredient

Market Authorisation Date: 19 December, 2014

Treatment: Treatment of inflammatory lesions of rosacea.

Dosage: CREAM;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.01	30 Dec, 2016	1	13 Sep, 2019	13 Mar, 2034	Eligible

Strength	Dosage	Availability
1%	CREAM;TOPICAL	Prescription

SOOLANTRA family patents

11. Tri-luma 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).
US8247395	GALDERMA LABS LP	Topical skin care composition	Oct, 2022 (1 year, 6 months ago)
US8653053	GALDERMA LABS LP	Topical skin care composition	Oct, 2022 (1 year, 6 months ago)
US7939516	GALDERMA LABS LP	Topical skin care composition	Sep, 2023 (7 months ago)
US7915243	GALDERMA LABS LP	Topical skin care composition	Sep, 2023 (7 months ago)

Drugs and Companies using FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN ingredient

Market Authorisation Date: 18 January, 2002

Treatment: NA

Dosage: CREAM;TOPICAL

Strength	Dosage	Availability
0.01%;4%;0.05%	CREAM;TOPICAL	Prescription

TRI-LUMA family patents

12. Twyneo 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).
US8617580	GALDERMA LABS LP	Compositions for topical application comprising a peroxide and retinoid	Feb, 2028 (3 years from now)
US9868103	GALDERMA LABS LP	Metal oxide coating of water insoluble ingredients	Aug, 2028 (4 years from now)
US10653899	GALDERMA LABS LP	Core stabilized microcapsules, method of their preparation and uses thereof	Dec, 2030 (6 years from now)
US11071878	GALDERMA LABS LP	Core stabilized microcapsules, method of their preparation and uses thereof	Dec, 2030 (6 years from now)
US10420743	GALDERMA LABS LP	Methods and compositions for the treatment of acne	Jul, 2038 (14 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;TOPICAL

Pharsight

Galderma Labs Lp patents expiration

1. Aklief patents expiration

AKLIEF family patents

2. Clobex patents expiration

CLOBEX family patents

3. Differin patents expiration

DIFFERIN family patents

4. Epiduo patents expiration

EPIDUO family patents

5. Epsolay patents expiration

EPSOLAY family patents

6. Metrogel patents expiration

METROGEL family patents

7. Metvixia patents expiration

METVIXIA family patents

8. Mirvaso patents expiration

MIRVASO family patents

9. Oracea patents expiration

ORACEA family patents

10. Soolantra patents expiration

SOOLANTRA family patents

11. Tri-luma patents expiration

TRI-LUMA family patents

12. Twyneo patents expiration

TWYNEO family patents

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