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Last Updated: February 27, 2021

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ADAPALENE; BENZOYL PEROXIDE - Generic Drug Details

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

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

Adapalene; benzoyl peroxide has one hundred and twenty-two patent family members in twenty-seven countries.

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

Summary for ADAPALENE; BENZOYL PEROXIDE
Recent Clinical Trials for ADAPALENE; BENZOYL PEROXIDE

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

SponsorPhase
BeiersdorfPhase 2
Mahidol UniversityPhase 2
New York University School of MedicineN/A

See all ADAPALENE; BENZOYL PEROXIDE clinical trials

Generic filers with tentative approvals for ADAPALENE; BENZOYL PEROXIDE
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; BENZOYL PEROXIDE
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for ADAPALENE; BENZOYL PEROXIDE
Tradename Dosage Ingredient NDA Submissiondate
EPIDUO FORTE GEL;TOPICAL adapalene; benzoyl peroxide 207917 2016-05-04
EPIDUO GEL;TOPICAL adapalene; benzoyl peroxide 022320 2011-12-30

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
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 EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 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; 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   Start Trial   Start Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ADAPALENE; BENZOYL PEROXIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 122008000041 Germany   Start Trial PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369 380 Finland   Start Trial
1458369 SPC/GB10/005 United Kingdom   Start Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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