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Generated: October 15, 2018

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Adapalene; benzoyl peroxide - Generic Drug Details

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

Adapalene; benzoyl peroxide is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Perrigo Israel, Taro, Tolmar, Galderma Labs Lp, and Galderma Labs, and is included in six NDAs. There are sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for adapalene; benzoyl peroxide. Six suppliers are listed for this compound.

Pharmacology for adapalene; benzoyl peroxide
Ingredient-typeRetinoids
Drug ClassRetinoid

US Patents and Regulatory Information for adapalene; benzoyl peroxide

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 206959-001 Jan 24, 2018 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
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for adapalene; benzoyl peroxide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for adapalene; benzoyl peroxide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/005 United Kingdom ➤ Sign Up PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369/01 Switzerland ➤ Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
2008000041 Germany ➤ Sign Up PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Fuji
AstraZeneca
Baxter
Boehringer Ingelheim
Dow
Mallinckrodt
Accenture
Chinese Patent Office

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