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Last Updated: June 29, 2022

Adapalene; benzoyl peroxide - Generic Drug Details


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What are the generic sources for adapalene; benzoyl peroxide and what is the scope of patent protection?

Adapalene; benzoyl peroxide is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, Galderma Labs Lp, and Galderma Labs, and is included in eight NDAs. There are sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide has one hundred and twenty-three patent family members in twenty-seven countries.

Nine suppliers are listed for this compound.

Summary for adapalene; benzoyl peroxide
Recent Clinical Trials for adapalene; benzoyl peroxide

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

SponsorPhase
Mahidol UniversityPhase 2
BeiersdorfPhase 2
Vichy LaboratoiresPhase 4

See all adapalene; benzoyl peroxide clinical trials

Pharmacology for adapalene; benzoyl peroxide
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for ADAPALENE; BENZOYL PEROXIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPIDUO FORTE Gel adapalene; benzoyl peroxide 0.3%/2.5% 207917 1 2016-05-04
EPIDUO Gel adapalene; benzoyl peroxide 0.1%/2.5% 022320 1 2011-12-30

US Patents and Regulatory Information for adapalene; benzoyl peroxide

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 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 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 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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 Y 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 adapalene; benzoyl peroxide

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 adapalene; benzoyl peroxide

Country Patent Number Title Estimated Expiration
Japan 2016029094 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) See Plans and Pricing
Russian Federation 2012144414 КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ See Plans and Pricing
Turkey 201819658 See Plans and Pricing
China 1642538 Use of adapalene for the treatment of dermatological disorders See Plans and Pricing
Poland 2450035 See Plans and Pricing
Denmark 1485080 See Plans and Pricing
Poland 220838 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for adapalene; benzoyl peroxide

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 122008000041 Germany See Plans and Pricing PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369 SPC/GB10/005 United Kingdom See Plans and Pricing PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 380 Finland See Plans and Pricing
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 CA 2008 00029 Denmark See Plans and Pricing PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 C01458369/01 Switzerland See Plans and Pricing 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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Harvard Business School
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