FDA Orange Book
Generic for Ziagen
Ziagen contains abacavir. 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 Ziagen is abacavir. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Ziagen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 20MG BASE/ML | Marketed (Rx) | AA | 2 | AA |
| tablet, oral | EQ 300MG BASE | Discontinued | None | 5 | AB |
NDA 020978, 020977, 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 abacavir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 091294 | AB (A-rated, therapeutically equivalent) | June 18, 2012 | EQ 300MG BASE |
| AUROBINDO PHARMA LTD | 077844 | AB (A-rated, therapeutically equivalent) | December 17, 2012 | EQ 300MG BASE |
| HETERO LABS LTD UNIT III | 091560 | AB (A-rated, therapeutically equivalent) | September 13, 2013 | EQ 300MG BASE |
| HETERO LABS LTD UNIT III | 201107 | AA (A-rated, therapeutically equivalent) | September 26, 2016 | EQ 20MG BASE/ML |
| CHARTWELL RX SCIENCES LLC | 091050 | AB (A-rated, therapeutically equivalent) | October 28, 2016 | EQ 300MG BASE |
| CIPLA LTD | 078119 | AB (A-rated, therapeutically equivalent) | November 21, 2017 | EQ 300MG BASE |
| AUROBINDO PHARMA LTD | 077950 | AA (A-rated, therapeutically equivalent) | March 14, 2018 | EQ 20MG BASE/ML |
Ziagen NDC codes
Questions
Is there a generic for Ziagen?
Yes. The generic name for Ziagen is abacavir. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Ziagen?
The active ingredient in Ziagen is abacavir, 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.