FDA Orange Book
Generic for Hepsera
Hepsera contains adefovir dipivoxil. 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 Hepsera is adefovir dipivoxil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Hepsera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 2 | AB |
NDA 021449, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic adefovir dipivoxil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SIGMAPHARM LABORATORIES LLC | 202051 | AB (A-rated, therapeutically equivalent) | August 29, 2013 | 10MG |
| APOTEX INC | 205459 | AB (A-rated, therapeutically equivalent) | July 6, 2018 | 10MG |
Questions
Is there a generic for Hepsera?
Yes. The generic name for Hepsera is adefovir dipivoxil. 2 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 Hepsera?
The active ingredient in Hepsera is adefovir dipivoxil, 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.