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Last Updated: November 27, 2022

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 five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Aleor Dermaceuticals, Encube Ethicals, Glenmark Generics, P And L, Taro, Taro Pharms, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Zydus Pharms, and Galderma Labs, and is included in twenty-seven NDAs. There are twenty-four 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. Twenty-six 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
University of OklahomaPhase 3
Dr.dr.Irma Bernadette, SpKK (K)Phase 1
Jonathan M TowarnickiEarly Phase 1

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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
Glenmark Pharms Ltd ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 208108-001 Nov 8, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
P And L ADAPALENE adapalene GEL;TOPICAL 090962-001 Jun 2, 2010 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SOLUTION;TOPICAL 020338-001 May 31, 1996 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for adapalene

Country Patent Number Title Estimated Expiration
Russian Federation 2008114840 КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ПО МЕНЬШЕЙ МЕРЕ ОДНО ПРОИЗВОДНОЕ НАФТОЕВОЙ КИСЛОТЫ И ПО МЕНЬШЕЙ МЕРЕ ОДНО СОЕДИНЕНИЕ ТИПА ПОЛИУРЕТАНОВОГО ПОЛИМЕРА ИЛИ ЕГО ПРОИЗВОДНОЕ, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ See Plans and Pricing
Spain 2327508 See Plans and Pricing
South Korea 20040111394 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 132008901685368 Italy See Plans and Pricing 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 See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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McKesson
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Boehringer Ingelheim

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.