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Last Updated: November 30, 2020

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Adapalene - Generic Drug Details

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What are the generic 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, Glenmark Generics, P And L, Taro, Tolmar, Call Inc, Glenmark Pharms Ltd, Perrigo Uk Finco, and Galderma Labs, and is included in twenty-two 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-five patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Twenty suppliers are listed for this compound. There is one tentative approval 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aurobindo Pharma LtdPhase 3
Assiut UniversityPhase 4
Foamix Ltd.Phase 2

See all adapalene clinical trials

Generic filers with tentative approvals for ADAPALENE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.3%;2.5%GEL; TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for adapalene
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for adapalene
Paragraph IV (Patent) Challenges for ADAPALENE
Tradename Dosage Ingredient NDA Submissiondate
DIFFERIN GEL;TOPICAL adapalene 021753 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 EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start 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 SOLUTION;TOPICAL 020338-001 May 31, 1996   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for adapalene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 SPC/GB10/005 United Kingdom   Start Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 132008901685368 Italy   Start Trial 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   Start Trial 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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Dow

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