FDA Orange Book
Generic for Baraclude
Baraclude contains entecavir. 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 Baraclude is entecavir. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Baraclude products the Orange Book lists.
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Baraclude products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 0.05MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 8 | AB |
NDA 021798, 021797, held by BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic entecavir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HETERO LABS LTD UNIT V | 205740 | AB (A-rated, therapeutically equivalent) | August 21, 2015 | 0.5MG, 1MG |
| AUROBINDO PHARMA LTD | 206217 | AB (A-rated, therapeutically equivalent) | August 26, 2015 | 0.5MG, 1MG |
| AMNEAL PHARMACEUTICALS | 206652 | AB (A-rated, therapeutically equivalent) | November 12, 2015 | 0.5MG, 1MG |
| CIPLA LTD | 206872 | AB (A-rated, therapeutically equivalent) | December 6, 2016 | 0.5MG, 1MG |
| ZYDUS PHARMACEUTICALS USA INC | 206745 | AB (A-rated, therapeutically equivalent) | June 23, 2017 | 0.5MG, 1MG |
| BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD | 212126 | AB (A-rated, therapeutically equivalent) | September 25, 2019 | 0.5MG, 1MG |
| YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD | 208195 | AB (A-rated, therapeutically equivalent) | November 10, 2021 | 0.5MG, 1MG |
| CONBA USA INC | 216857 | AB (A-rated, therapeutically equivalent) | December 23, 2024 | 0.5MG, 1MG |
Baraclude NDC codes
Questions
Is there a generic for Baraclude?
Yes. The generic name for Baraclude is entecavir. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Baraclude products the Orange Book lists.
What is the generic name for Baraclude?
The active ingredient in Baraclude is entecavir, 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.