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FDA Orange Book · active-ingredient family

Adapalene; benzoyl peroxide

Adapalene; benzoyl peroxide is approved as 3 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DIFFERIN EPIDUO · NDA 220736

3

Brand (NDA)

10

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · gel

ProductApplicantApplicationTEApproved
DIFFERIN EPIDUORLDGALDERMA LABS LPNDA 220736—May 22, 2026
EPIDUO FORTERLDGALDERMA LABSNDA 207917ABJul 15, 2015
EPIDUORLDGALDERMA LABS LPNDA 022320ABDec 08, 2008

Generic (ANDA) products (10)

ProductApplicantApplicationTEApproved
ADAPALENE AND BENZOYL PEROXIDEALEMBICANDA 214185ABAug 04, 2022
ADAPALENE AND BENZOYL PEROXIDEACTAVIS LABS UT INCANDA 209641ABJun 22, 2022
ADAPALENE AND BENZOYL PEROXIDEZYDUS PHARMSANDA 214553ABJun 03, 2022
ADAPALENE AND BENZOYL PEROXIDEPADAGIS ISRAELANDA 212464ABMay 31, 2022
ADAPALENE AND BENZOYL PEROXIDEGLENMARK PHARMS LTDANDA 208108ABNov 08, 2019
ADAPALENE AND BENZOYL PEROXIDESUN PHARMA CANADAANDA 209148ABOct 17, 2018
ADAPALENE AND BENZOYL PEROXIDEENCUBEANDA 206164ABMay 23, 2018
ADAPALENE AND BENZOYL PEROXIDESUN PHARMA CANADAANDA 206959ABJan 24, 2018
ADAPALENE AND BENZOYL PEROXIDEPADAGIS ISRAELANDA 205033ABJan 23, 2018
ADAPALENE AND BENZOYL PEROXIDEACTAVIS MID ATLANTICANDA 203790—Sep 30, 2015

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8080537Jul 18, 2027in 1 yr 1 mo
U-1078
8129362Jul 18, 2027in 1 yr 1 mo
U-1078
8071644Jul 18, 2027in 1 yr 1 mo
ProductU-1078

Adapalene; benzoyl peroxide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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