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Last Updated: May 28, 2020

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EPIDUO Drug Profile


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Which patents cover Epiduo, 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 eighty-three patent family members in twenty-six countries.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

US ANDA Litigation and Generic Entry Outlook for Epiduo

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (adapalene; benzoyl peroxide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for EPIDUO
Drug Prices for EPIDUO

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Drug Sales Revenue Trends for EPIDUO

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Recent Clinical Trials for EPIDUO

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

SponsorPhase
Mahidol UniversityPhase 2
BeiersdorfPhase 2
Vichy LaboratoiresPhase 4

See all EPIDUO clinical trials

Recent Litigation for EPIDUO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories LP v. Taro Pharmaceuticals USA Inc2016-07-29
Galderma Laboratories, L.P. v. Actavis Mid Atlantic LLC
Galderma Laboratories LP v. Tolmar Inc.

See all EPIDUO litigation

Pharmacology for EPIDUO
Drug ClassRetinoid
Synonyms for EPIDUO
1194805-81-6
Adapalene / benzoyl peroxide
Adapalene mixture with benzoyl peroxide
Adapalene-benzoyl peroxide mixt.
Adapalene-BPO
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl peroxide - differin mixt.
Benzoyl peroxide / Adapalene
DTXSID30152465
Epiduo Forte
SCHEMBL60989
Paragraph IV (Patent) Challenges for EPIDUO
Tradename Dosage Ingredient NDA Submissiondate
EPIDUO GEL;TOPICAL adapalene; benzoyl peroxide 022320 2011-12-30

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   Start Trial   Start Trial Y   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
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 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
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 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 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   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 EPIDUO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 08C0024 France   Start Trial PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
0199636 300209 Netherlands   Start Trial 300209, 20060411, EXPIRES: 20070702
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 C01458369/01 Switzerland   Start Trial PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 SPC/GB10/005 United Kingdom   Start Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 380 Finland   Start Trial
1458369 132008901685368 Italy   Start Trial 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:

Moodys
Johnson and Johnson
McKinsey
Express Scripts
Colorcon
Medtronic

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