FDA Orange Book · active-ingredient family
Entecavir
Entecavir: 2 brands, 18 generics; first approved Mar 29, 2005; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
18
Listed patents
0
Presentations
39
Brand (NDA) products
Originator applications
- BRISTOL MYERS SQUIBBNDA 0217982005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML SOLUTION ORAL Rx — - BARACLUDERLDBRISTOL MYERS SQUIBBNDA 02179720052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB
Generic (ANDA) products (18)
Abbreviated applications
- ENTECAVIRCONBA USAANDA 21685720242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRYUNG SHIN PHARMANDA 20819520212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRPHARMADAXANDA 21210620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRSUNSHINEANDA 21197820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRYAOPHARMA CO LTDANDA 21220120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRBRIGHTGENEANDA 21212620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRRISINGANDA 20622620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRBRECKENRIDGEANDA 20872120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRPRINSTON INCANDA 20878220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRACCORD HLTHCAREANDA 20582420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRZYDUS PHARMSANDA 20674520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRCHARTWELL RXANDA 20667220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRCIPLAANDA 20687220162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRCHARTWELL RXANDA 20629420162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - ENTECAVIRAMNEAL PHARMSANDA 20665220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRAUROBINDO PHARMAANDA 20621720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRHETERO LABS LTD VANDA 20574020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB - ENTECAVIRTEVA PHARMS USAANDA 20212220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued —
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
21 yr 8 mo ago
Most recent approval
1 yr 8 mo ago
Approvals span 2005–2024 across 20 FDA applications.
Brand (NDA) 210%
Generic (ANDA) 1890%
Entecavir: 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.
