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Last Updated: May 19, 2022

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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four 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. Nine suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Drug patent expirations by year for EPIDUO
Drug Prices for EPIDUO

See drug prices for EPIDUO

Drug Sales Revenue Trends for EPIDUO

See drug sales revenues for EPIDUO

Recent Clinical Trials for EPIDUO

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

SponsorPhase
Bausch Health Americas, Inc.Phase 2
BeiersdorfPhase 2
Mahidol UniversityPhase 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 ten 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treatment of common acne
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07274288
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0713182
Estimated Expiration: See Plans and Pricing

Canada

Patent: 56456
Estimated Expiration: See Plans and Pricing

China

Patent: 1541320
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 50136
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14473
Estimated Expiration: See Plans and Pricing

Patent: 21398
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 46318
Estimated Expiration: See Plans and Pricing

Patent: 50035
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 46318
Estimated Expiration: See Plans and Pricing

Patent: 50035
Estimated Expiration: See Plans and Pricing

France

Patent: 03603
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 43502
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09542779
Estimated Expiration: See Plans and Pricing

Patent: 14040481
Estimated Expiration: See Plans and Pricing

Patent: 16029094
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 50035
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09000319
Estimated Expiration: See Plans and Pricing

Poland

Patent: 46318
Estimated Expiration: See Plans and Pricing

Patent: 50035
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 46318
Estimated Expiration: See Plans and Pricing

Patent: 50035
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 09104949
Estimated Expiration: See Plans and Pricing

Patent: 12136952
Estimated Expiration: See Plans and Pricing

Patent: 12144414
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 46318
Estimated Expiration: See Plans and Pricing

Patent: 50035
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 090028764
Estimated Expiration: See Plans and Pricing

Patent: 150003917
Estimated Expiration: See Plans and Pricing

Patent: 160120352
Estimated Expiration: See Plans and Pricing

Spain

Patent: 23951
Estimated Expiration: See Plans and Pricing

Patent: 03505
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1819658
Estimated Expiration: See Plans and Pricing

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
China 1607946 See Plans and Pricing
Spain 8705845 See Plans and Pricing
Spain 2275948 See Plans and Pricing
European Patent Office 0199636 BENZONAPHTHALENIC DERIVATIVES, PROCESS FOR THEIR PREPARATION AND THEIR USE IN PHARMACY AND COSMETICS See Plans and Pricing
Australia 2002364437 See Plans and Pricing
Japan S61251632 BENZONAPHTHALENE DERIVATIVE, MANUFACTURE AND THERAPEUTICAL AND COSMETIC USE See Plans and Pricing
Ireland 860931 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPIDUO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 08C0024 France See Plans and Pricing PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369 C01458369/01 Switzerland See Plans and Pricing PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 CA 2008 00029 Denmark See Plans and Pricing PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 132008901685368 Italy See Plans and Pricing PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1458369 SPC/GB10/005 United Kingdom See Plans and Pricing PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0199636 300209 Netherlands See Plans and Pricing 300209, 20060411, EXPIRES: 20070702
1458369 SZ 31/2008 Austria See Plans and Pricing PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
McKinsey
Express Scripts
Colorcon
Medtronic

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.