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Last Updated: June 24, 2024

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EPIDUO Drug Patent 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 five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in twenty-five countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Epiduo

A generic version of EPIDUO was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23rd, 2018.

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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

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SponsorPhase
Bausch Health Americas, Inc.Phase 2
Mahidol UniversityPhase 2
BeiersdorfPhase 2

See all EPIDUO clinical trials

Pharmacology for EPIDUO
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for EPIDUO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPIDUO Gel adapalene; benzoyl peroxide 0.1%/2.5% 022320 1 2011-12-30

US Patents and Regulatory Information for EPIDUO

EPIDUO is protected by five US patents.

Patents protecting EPIDUO

Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for treatment of common acne
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACNE

Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACNE

Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACNE

Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACNE

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 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 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
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 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 Y ⤷  Sign Up
>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

International Patents for EPIDUO

When does loss-of-exclusivity occur for EPIDUO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1989
Patent: COMBINACION DE PEROXIDO DE ADAPALENO Y BENZOILO PARA EL TRATAMIENTO DE LESIONES DE ACNE
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 07274288
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0713182
Patent: usos de adapaleno de um de seus sais farmaceuticamente aceitáveis, kit e produto
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 56456
Patent: ADAPALENE ET PEROXYDE DE BENZOYLE COMBINES UTILISES DANS LE TRAITEMENT DE LESIONS DUES A L'ACNE (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1541320
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 50136
Patent: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAR LESIONES DE ACNE
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 14473
Estimated Expiration: ⤷  Sign Up

Patent: 21398
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 46318
Estimated Expiration: ⤷  Sign Up

Patent: 50035
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 46318
Patent: Combinaison d'adapalène et de peroxyde de benzoyle pour le traitement de lésions inflammatoires de l'acné (Combination of adapalene and benzoyl peroxide for treating inflammatory acne lesions)
Estimated Expiration: ⤷  Sign Up

Patent: 50035
Patent: Combinaison d'adapalène et de péroxyde de benzoyle dans le traitement des lésions acnéiques (Combination of adapalene and benzoyl peroxide for treating acne lesions)
Estimated Expiration: ⤷  Sign Up

France

Patent: 03603
Patent: COMBINAISON D'ADAPALENE ET DE PEROXYDE DE BENZOLE DANS LE TRAITEMENT DE L'ACNE (Use of adapalene for the preparation of composition to be administered in combination/in association with benzoyl peroxide for reducing the number of acne injuries such as inflammatory and/or non-inflammatory type)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 43502
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 09542779
Estimated Expiration: ⤷  Sign Up

Patent: 14040481
Patent: COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷  Sign Up

Patent: 16029094
Patent: 座瘡病変の治療のためのアダパレンと過酸化ベンゾイルとの組合せ (COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 50035
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09000319
Patent: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAMIENTO DE LESIONES DEL ACNE. (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 46318
Estimated Expiration: ⤷  Sign Up

Patent: 50035
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 46318
Estimated Expiration: ⤷  Sign Up

Patent: 50035
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 09104949
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷  Sign Up

Patent: 12136952
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷  Sign Up

Patent: 12144414
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 46318
Estimated Expiration: ⤷  Sign Up

Patent: 50035
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 090028764
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷  Sign Up

Patent: 150003917
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷  Sign Up

Patent: 160120352
Patent: 여드름 병변 치료를 위한 아다팔렌 및 벤조일 퍼옥시드의 조합물 (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 23951
Estimated Expiration: ⤷  Sign Up

Patent: 03505
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1819658
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EPIDUO around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2008006888 ⤷  Sign Up
Denmark 2114392 ⤷  Sign Up
Hungary 0500006 ⤷  Sign Up
Brazil PI0214264 composição, processos para sua preparação e usos de uma composição ⤷  Sign Up
Spain 554186 ⤷  Sign Up
Japan 5478468 ⤷  Sign Up
Argentina 038026 GEL QUE COMPRENDE AL MENOS UN RETINOIDE Y PEROXIDO DE BENZOILO ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPIDUO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 132008901685368 Italy ⤷  Sign Up PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1458369 SZ 31/2008 Austria ⤷  Sign Up PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1458369 CA 2008 00029 Denmark ⤷  Sign Up PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 C01458369/01 Switzerland ⤷  Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 122008000041 Germany ⤷  Sign Up PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369 08C0024 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
1458369 SPC/GB10/005 United Kingdom ⤷  Sign Up PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.