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Last Updated: November 2, 2024

ADAPALENE - Generic Drug Details


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What are the generic drug sources for adapalene and what is the scope of patent protection?

Adapalene is the generic ingredient in six branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms Inc, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Zydus Pharms, Galderma Labs, and Bausch, and is included in twenty-eight NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has fifty-six patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Forty suppliers are listed for this compound.

Summary for ADAPALENE
Drug Prices for ADAPALENE

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Drug Sales Revenue Trends for ADAPALENE

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Recent Clinical Trials for ADAPALENE

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SponsorPhase
HITEC-Institute of Medical SciencesN/A
Mansoura UniversityPhase 2
University of OklahomaPhase 3

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Pharmacology for ADAPALENE
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for ADAPALENE
Paragraph IV (Patent) Challenges for ADAPALENE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIFFERIN Topical Gel adapalene 0.30% 021753 1 2009-09-15

US Patents and Regulatory Information for ADAPALENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Call Inc ADAPALENE adapalene SOLUTION;TOPICAL 203981-001 Sep 23, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ADAPALENE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ADAPALENE

Country Patent Number Title Estimated Expiration
Cyprus 1109307 ⤷  Sign Up
Japan 5722598 ⤷  Sign Up
Poland 216763 ⤷  Sign Up
European Patent Office 1532974 Composition comprenant de l'acide 6-[3-(1-adamantyl)-4-méthoxyphényl]-2-naphthanoique pour le traitement de troubles dermatologiques (Composition comprising 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ADAPALENE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 SPC/GB10/005 United Kingdom ⤷  Sign Up PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 132008901685368 Italy ⤷  Sign Up PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1458369 08C0024 France ⤷  Sign Up PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.