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Last Updated: September 23, 2021

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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, Padagis Israel, 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-six patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Twenty-four 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

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SponsorPhase
Edward Lain, MDPhase 4
Vyne Therapeutics Inc.Phase 4
Bausch Health Americas, Inc.Phase 2

See all adapalene clinical trials

Generic filers with tentative approvals for ADAPALENE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free0.3%;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 DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Call Inc ADAPALENE adapalene SOLUTION;TOPICAL 204593-001 Jan 5, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taro ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206959-001 Jan 24, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 08C0024 France ⤷  Try it Free PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369 132008901685368 Italy ⤷  Try it Free 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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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Express Scripts
Merck
Moodys
Dow

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