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Last Updated: February 22, 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 fourteen 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 seven patent family members in twenty-six 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
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"N/A
delta medical promotions agN/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
Encube ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206164-001 May 23, 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
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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Poland 372317 Zastosowanie kwasu 6-[3-(1-adamantylo)-4-metoksyfenylo]-2-naftalenokarboksylowego (USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS) ⤷  Try a Trial
South Korea 20050016290 ⤷  Try a Trial
Australia 2008203279 Use of adapalene for the treatment of dermatological disorders ⤷  Try a Trial
South Africa 200405853 Use of adapalene for the treatment of dermatological disorders ⤷  Try a Trial
Mexico 2009000319 COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAMIENTO DE LESIONES DEL ACNE. (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS.) ⤷  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 C01458369/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
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 122008000041 Germany ⤷  Try a Trial PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
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