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Last Updated: April 6, 2020

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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.

This drug has one hundred and twenty-one patent family members in twenty-seven countries.

The generic ingredient in EPIDUO FORTE 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 Forte

There have been two 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 FORTE
Drug Prices for EPIDUO FORTE

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Drug Sales Revenue Trends for EPIDUO FORTE

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Recent Clinical Trials for EPIDUO FORTE

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

SponsorPhase
BeiersdorfPhase 2
Mahidol UniversityPhase 2
Vichy LaboratoiresPhase 4

See all EPIDUO FORTE clinical trials

Recent Litigation for EPIDUO FORTE

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

See all EPIDUO FORTE litigation

Pharmacology for EPIDUO FORTE
Drug ClassRetinoid
Synonyms for EPIDUO FORTE
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
SCHEMBL60989
Paragraph IV (Patent) Challenges for EPIDUO FORTE
Tradename Dosage Ingredient NDA Submissiondate
EPIDUO FORTE GEL;TOPICAL adapalene; benzoyl peroxide 207917 2016-05-04

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 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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 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

Supplementary Protection Certificates for EPIDUO FORTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1458369 CA 2008 00029 Denmark   Start Trial PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 380 Finland   Start Trial
1458369 SZ 31/2008 Austria   Start Trial PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Medtronic
Johnson and Johnson
Harvard Business School
Moodys

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