FDA Orange Book
Generic for Treximet
Treximet contains sumatriptan and naproxen. 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 Treximet is sumatriptan and naproxen. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Treximet products the Orange Book lists.
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Treximet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 500MG;EQ 85MG BASE | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 60MG;EQ 10MG BASE | Discontinued | None | 0 | None |
NDA 021926, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sumatriptan and naproxen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 207457 | AB (A-rated, therapeutically equivalent) | February 15, 2018 | 500MG;EQ 85MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 202803 | AB (A-rated, therapeutically equivalent) | July 20, 2018 | 500MG;EQ 85MG BASE |
| RISING PHARMA HOLDINGS INC | 090872 | AB (A-rated, therapeutically equivalent) | September 4, 2018 | 500MG;EQ 85MG BASE |
Treximet patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7332183 | October 2, 2025 | Drug product | U-1719 | 021926 |
| 7332183 | October 2, 2025 | Drug product | U-867 | 021926 |
| 7332183*PED | April 2, 2026 | Method of use | None | 021926 |
Treximet NDC codes
Questions
Is there a generic for Treximet?
Yes. The generic name for Treximet is sumatriptan and naproxen. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Treximet products the Orange Book lists.
What is the generic name for Treximet?
The active ingredient in Treximet is sumatriptan and naproxen, per the FDA Orange Book.
When does the Treximet patent expire?
The last patent listed for Treximet in the Orange Book expires April 2, 2026. 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.