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FDA Orange Book · active-ingredient family

Ezetimibe

Ezetimibe is approved as 1 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZETIA · NDA 021445

1

Brand (NDA)

16

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ZETIARLDORGANONNDA 021445ABOct 25, 2002

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
EZETIMIBEMACLEODS PHARMS LTDANDA 211159—Apr 29, 2024
EZETIMIBEORIENT PHARMAANDA 215693ABSep 13, 2022
EZETIMIBEHETERO LABS LTD IIIANDA 210859ABJul 26, 2022
EZETIMIBESCIEGEN PHARMSANDA 210673ABOct 23, 2020
EZETIMIBERISINGANDA 201790—Apr 26, 2019
EZETIMIBEACCORD HLTHCAREANDA 211550ABOct 26, 2018
EZETIMIBEALKEM LABS LTDANDA 209234ABDec 21, 2017
EZETIMIBEAUROBINDO PHARMAANDA 209838ABAug 25, 2017
EZETIMIBEAMNEAL PHARMS COANDA 208803ABJun 12, 2017
EZETIMIBEAPOTEXANDA 208332—Jun 12, 2017
EZETIMIBEOHM LABS INCANDA 207311ABJun 12, 2017
EZETIMIBESANDOZANDA 203931ABJun 12, 2017
EZETIMIBETEVA PHARMS USAANDA 078724—Jun 12, 2017
EZETIMIBEWATSON LABS INCANDA 200831ABJun 12, 2017
EZETIMIBEZYDUS PHARMSANDA 204331ABJun 12, 2017
EZETIMIBEGLENMARK PHARMS LTDANDA 078560ABJun 26, 2015

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7612058Oct 30, 20258 mo ago
U-1173
7612058*PEDApr 30, 20262 mo ago

Ezetimibe — frequently asked questions

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

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