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Last Updated: March 29, 2024

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 four branded drugs marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, Zydus Pharms, Galderma Labs Lp, Galderma Labs, and Bausch, and is included in thirteen NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide has sixty-eight patent family members in twenty-five countries.

Thirteen 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
University of OklahomaPhase 3
delta medical promotions agN/A
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"N/A

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 Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Taro ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 209148-001 Oct 17, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Ut Inc ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 209641-001 Jun 22, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

International Patents for adapalene; benzoyl peroxide

Country Patent Number Title Estimated Expiration
Cyprus 1107583 ⤷  Try a Trial
Mexico PA04005918 GEL QUE COMPRENDE AL MENOS UN RETINOIDE Y PEROXIDO DE BENZOILO. (GEL COMPRISING AT LEAST A RETINOID AND BENZOYL PEROXIDE.) ⤷  Try a Trial
European Patent Office 1458369 GEL COMPRENANT AU MOINS UN RETINOIDE ET DU PEROXYDE DE BENZOYLE (GEL COMPRISING AT LEAST A RETINOID AND BENZOYL PEROXIDE) ⤷  Try a Trial
Brazil PI0713182 usos de adapaleno de um de seus sais farmaceuticamente aceitáveis, kit e produto ⤷  Try a Trial
France 2903603 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) ⤷  Try a Trial
Japan 2005513146 ⤷  Try a Trial
>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 CA 2008 00029 Denmark ⤷  Try a Trial PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 132008901685368 Italy ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1458369 C01458369/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 08C0024 France ⤷  Try a Trial PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369 380 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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