FDA Orange Book
Generic for Lexiva
Lexiva contains fosamprenavir. 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 Lexiva is fosamprenavir. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Lexiva products the Orange Book lists.
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Lexiva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | EQ 50MG BASE/ML | Discontinued | None | 0 | None |
| tablet, oral | EQ 700MG BASE | Discontinued | None | 2 | AB |
NDA 022116, 021548, held by VIIV HEALTHCARE CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fosamprenavir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 204060 | AB (A-rated, therapeutically equivalent) | April 15, 2016 | EQ 700MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 204024 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | EQ 700MG BASE |
Questions
Is there a generic for Lexiva?
Yes. The generic name for Lexiva is fosamprenavir. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Lexiva products the Orange Book lists.
What is the generic name for Lexiva?
The active ingredient in Lexiva is fosamprenavir, 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.