FDA Orange Book
Generic for Axert
Axert contains almotriptan malate. 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 Axert is almotriptan malate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Axert products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 12.5MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 6.25MG BASE | Discontinued | None | 3 | AB |
NDA 021001, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic almotriptan malate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 078027 | AB (A-rated, therapeutically equivalent) | July 7, 2015 | EQ 12.5MG BASE, EQ 6.25MG BASE |
| MYLAN PHARMACEUTICALS INC | 205171 | AB (A-rated, therapeutically equivalent) | November 9, 2015 | EQ 12.5MG BASE, EQ 6.25MG BASE |
| AJANTA PHARMA LTD | 205523 | AB (A-rated, therapeutically equivalent) | March 3, 2016 | EQ 12.5MG BASE, EQ 6.25MG BASE |
Questions
Is there a generic for Axert?
Yes. The generic name for Axert is almotriptan malate. 3 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 Axert?
The active ingredient in Axert is almotriptan malate, 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.