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Last Updated: November 21, 2019

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EPIDUO FORTE Drug Profile

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Which patents cover Epiduo Forte, and when can generic versions of Epiduo Forte launch?

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 eighteen 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. 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 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

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SponsorPhase
BeiersdorfPhase 2
Mahidol UniversityPhase 2
Vichy LaboratoiresPhase 4

See all EPIDUO FORTE clinical trials

Recent Litigation for EPIDUO FORTE

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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 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 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 CA 2008 00029 Denmark   Start Trial PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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
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

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