FDA Orange Book · active-ingredient family
Ezetimibe
Ezetimibe: 1 brand, 16 generics; first approved Oct 25, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
16
Listed patents
2
Next patent expiry
Oct 30, 2025
10 mo ago
Brand (NDA) products
Originator applications
- ORGANONNDA 0214452002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB
Generic (ANDA) products (16)
Abbreviated applications
- EZETIMIBEMACLEODS PHARMS LTDANDA 2111592024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - EZETIMIBEORIENT PHARMAANDA 2156932022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBEHETERO LABS LTD IIIANDA 2108592022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBESCIEGEN PHARMSANDA 2106732020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBERISINGANDA 2017902019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - EZETIMIBEACCORD HLTHCAREANDA 2115502018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBEALKEM LABS LTDANDA 2092342017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBEAUROBINDO PHARMAANDA 2098382017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBEAMNEAL PHARMS COANDA 2088032017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBEAPOTEXANDA 2083322017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - EZETIMIBEOHM LABS INCANDA 2073112017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBESANDOZANDA 2039312017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBETEVA PHARMS USAANDA 0787242017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - EZETIMIBEWATSON LABS INCANDA 2008312017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBEZYDUS PHARMSANDA 2043312017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - EZETIMIBEGLENMARK PHARMS LTDANDA 0785602015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7612058 | 10 mo ago | U-1173 | |
| 7612058*PED | 3 mo ago |
Approval history
FDA approval span
First approval
24 yr 2 mo ago
Most recent approval
2 yr 4 mo ago
Approvals span 2002–2024 across 17 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1694%
Ezetimibe: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
