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Last Updated: April 22, 2024

Adapalene - Generic Drug Details


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What are the generic drug sources for adapalene and what is the scope of freedom to operate?

Adapalene is the generic ingredient in six branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Generics, 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. Thirty-eight suppliers are listed for this compound.

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
Mansoura UniversityPhase 2
University of OklahomaPhase 3
Dr.dr.Irma Bernadette, SpKK (K)Phase 1

See all adapalene clinical trials

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
Taro ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 209148-001 Oct 17, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro ADAPALENE adapalene GEL;TOPICAL 208322-001 Jun 23, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glenmark Pharms Ltd ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 208108-001 Nov 8, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for adapalene

Country Patent Number Title Estimated Expiration
Australia 2006290364 Composition comprising at least one naphthoic acid derivative and at least one compound of polyurethane polymer type or derivatives thereof, preparation processes therefor and uses thereof ⤷  Try a Trial
Russian Federation 2332208 ПРИМЕНЕНИЕ 6-[3-(1-АДАМАНТИЛ)-4-МЕТОКСИФЕНИЛ]-2-НАФТОЙНОЙ КИСЛОТЫ ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ (APPLICATION OF 6-[3-(1-ADAMANTYL)-4-METHOXYPHENYL]-2-NAPHTHOIC ACID FOR DERMATOLOGICAL DISORDER TREATMENT) ⤷  Try a Trial
Spain 2327508 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03075908 ⤷  Try a Trial
Mexico 2008003422 COMPOSICIONES QUE COMPRENDEN AL MENOS UN DERIVADO DE ACIDO NAFTOICO Y AL MENOS UN COMPUESTO DE TIPO POLIMERO DE POLIURETANO O DERIVADOS DEL MISMO, PROCESOS DE PREPARACION Y COMPOSICIONES QUE COMPRENDEN AL MENOS UN DERIVADO DE ACIDO NAFTOICO Y AL MENO (COMPOSITION COMPRISING AT LEAST ONE NAPHTHOIC ACID DERIVATIVE AND AT LEAST ONE COMPOUND OF POLYURETHANE POLYMER TYPE OR DERIVATIVES THEREOF, PREPARATION PROCESSES THEREFOR AND USES THEREOF.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for adapalene

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