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Generated: September 19, 2018

DrugPatentWatch Database Preview

EPIDUO FORTE Drug Profile

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Which patents cover Epiduo Forte, and what generic alternatives are available?

Epiduo Forte is a drug marketed by Galderma Labs and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in EPIDUO FORTE 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.

US Patents and Regulatory Information for EPIDUO FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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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Paragraph IV (Patent) Challenges for EPIDUO FORTE
Drugname Dosage Strength RLD Date
➤ Subscribe Gel 0.3%/2.5% ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for EPIDUO FORTE

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
9,622,994 Method for the treatment of acne using pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid ➤ Sign Up
9,872,842 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Sign Up
8,071,644 Combinations of adapalene and benzoyl peroxide for treating acne lesions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for EPIDUO FORTE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
31/2008 Austria ➤ Sign Up PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
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:

Accenture
Argus Health
Chubb
US Army
Johnson and Johnson
Colorcon
Cantor Fitzgerald
Cipla
UBS

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