FDA Orange Book · active-ingredient family
Entacapone
Entacapone: 1 brand, 8 generics; first approved Oct 19, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
- ORION PHARMANDA 0207961999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB
Generic (ANDA) products (8)
Abbreviated applications
- ENTACAPONEALEMBICANDA 2126012022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ENTACAPONESUNSHINEANDA 2066692018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ENTACAPONEAJANTA PHARMA LTDANDA 2057922017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ENTACAPONEMACLEODS PHARMS LTDANDA 2072102017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ENTACAPONEAUROBINDO PHARMA LTDANDA 2034372015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ENTACAPONEPHARMOBEDIENTANDA 2023942013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - ENTACAPONEWOCKHARDT BIO AGANDA 0789412012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - ENTACAPONESUN PHARMANDA 0906902012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
27 yr 3 mo ago
Most recent approval
4 yr 8 mo ago
Approvals span 1999–2022 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Entacapone: 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.
