FDA Orange Book
Generic for Antizol
Antizol contains fomepizole. 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 Antizol is fomepizole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Antizol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1.5GM/1.5ML (1GM/ML) | Discontinued | None | 4 | AP |
NDA 020696, held by PAR PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fomepizole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMERICAN REGENT INC | 078368 | AP (A-rated, therapeutically equivalent) | December 14, 2007 | 1.5GM/1.5ML (1GM/ML) |
| MYLAN INSTITUTIONAL LLC | 078639 | AP (A-rated, therapeutically equivalent) | March 3, 2008 | 1.5GM/1.5ML (1GM/ML) |
| NAVINTA LLC | 078537 | AP (A-rated, therapeutically equivalent) | March 6, 2008 | 1.5GM/1.5ML (1GM/ML) |
| GLAND PHARMA LTD | 216791 | AP (A-rated, therapeutically equivalent) | July 6, 2023 | 1.5GM/1.5ML (1GM/ML) |
Antizol patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7553863 | June 30, 2027 | Drug substance, Drug product | None | 020696 |
Questions
Is there a generic for Antizol?
Yes. The generic name for Antizol is fomepizole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Antizol?
The active ingredient in Antizol is fomepizole, per the FDA Orange Book.
When does the Antizol patent expire?
The last patent listed for Antizol in the Orange Book expires June 30, 2027. A listed patent expiry date is not a generic launch date.
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.