FDA Orange Book
Generic for Epivir-hbv
Epivir-hbv contains lamivudine. 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 Epivir-hbv is lamivudine. 3 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 Epivir-hbv products the Orange Book lists.
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Epivir-hbv products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 5MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 100MG | Discontinued | None | 3 | AB |
NDA 021004, 021003, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lamivudine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 202941 | AB (A-rated, therapeutically equivalent) | January 2, 2014 | 100MG |
| HETERO LABS LTD UNIT V | 203260 | AB (A-rated, therapeutically equivalent) | January 2, 2014 | 100MG |
| ANNORA PHARMA PRIVATE LTD | 211306 | AB (A-rated, therapeutically equivalent) | March 21, 2019 | 100MG |
Questions
Is there a generic for Epivir-hbv?
Yes. The generic name for Epivir-hbv is lamivudine. 3 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 Epivir-hbv products the Orange Book lists.
What is the generic name for Epivir-hbv?
The active ingredient in Epivir-hbv is lamivudine, 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.