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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
Cantor Fitzgerald
Healthtrust
US Department of Justice
Fish and Richardson
Fuji
Covington
Cipla

Generated: May 20, 2018

DrugPatentWatch Database Preview

EPIDUO Drug Profile

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When do Epiduo patents expire, and when can generic versions of Epiduo launch?

Epiduo is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in two NDAs. There are sixteen patents protecting this drug and two Paragraph IV challenges.

This drug has seventy-three patent family members in twenty-four countries.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Drug patent expirations by year for EPIDUO
Pharmacology for EPIDUO
Ingredient-typeRetinoids
Drug ClassRetinoid

US Patents and Regulatory Information for EPIDUO

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 ➤ 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
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ➤ 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 ➤ 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 EPIDUO

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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Paragraph IV (Patent) Challenges for EPIDUO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Gel 0.3%/2.5% ➤ Subscribe 2016-05-04
➤ Subscribe Gel 0.1%/2.5% ➤ Subscribe 2011-12-30

Non-Orange Book US Patents for EPIDUO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,785,420 Combination/association of adapalene and benzoyl peroxide for treating acne lesions ➤ Sign Up
9,814,690 Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for EPIDUO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008000041 Germany ➤ Sign Up PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
31/2008 Austria ➤ Sign Up PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1458369/01 Switzerland ➤ Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
C0024 France ➤ Sign Up PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Cantor Fitzgerald
Chinese Patent Office
Covington
UBS
Johnson and Johnson
Moodys
US Army
Daiichi Sankyo

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