FDA Orange Book · active-ingredient family
Famciclovir
Famciclovir: 1 brand, 8 generics; first approved Jun 29, 1994; 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
27
Brand (NDA) products
Originator applications
- FAMVIRRLDNOVARTISNDA 02036319953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 125MG TABLET ORAL Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- FAMCICLOVIRHETERO LABS LTD VANDA 20243820143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - FAMCICLOVIRMACLEODS PHARMS LTDANDA 20102220123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - FAMCICLOVIRAPOTEXANDA 09148020113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - FAMCICLOVIRNATCO PHARMAANDA 20133320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - FAMCICLOVIRAUROBINDO PHARMA LTDANDA 09111420113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - FAMCICLOVIRCIPLAANDA 07827820113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - FAMCICLOVIRHIKMAANDA 09012820113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - FAMCICLOVIRTEVA PHARMSANDA 07748720073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 500MG 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
32 yr 7 mo ago
Most recent approval
12 yr 1 mo ago
Approvals span 1994–2014 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Famciclovir: 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.
