FDA Orange Book
Generic for Famvir
Famvir contains famciclovir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Famvir is famciclovir. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Famvir products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 125MG | Discontinued | None | 4 | AB |
| tablet, oral | 250MG | Discontinued | None | 4 | AB |
| tablet, oral | 500MG | Discontinued | None | 4 | AB |
NDA 020363, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic famciclovir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 077487 | AB (A-rated, therapeutically equivalent) | August 24, 2007 | 125MG, 250MG, 500MG |
| AUROBINDO PHARMA LTD | 091114 | AB (A-rated, therapeutically equivalent) | March 21, 2011 | 125MG, 250MG, 500MG |
| MACLEODS PHARMACEUTICALS LTD | 201022 | AB (A-rated, therapeutically equivalent) | January 12, 2012 | 125MG, 250MG, 500MG |
| HETERO LABS LTD UNIT V | 202438 | AB (A-rated, therapeutically equivalent) | September 10, 2014 | 125MG, 250MG, 500MG |
Questions
Is there a generic for Famvir?
Yes. The generic name for Famvir is famciclovir. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Famvir?
The active ingredient in Famvir is famciclovir, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.