FDA Orange Book
Is there a generic for Xatmep?
Xatmep contains methotrexate. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xatmep (methotrexate). The Orange Book shows its last listed patent expires January 2, 2033.
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Xatmep products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 2.5MG BASE/ML | Marketed (Rx) | None | 0 | None |
NDA 208400, 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.
Xatmep patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10231927 | January 2, 2033 | Method of use | U-1699 | 208400 |
| 10231927 | January 2, 2033 | Method of use | U-1349 | 208400 |
| 11116724 | January 2, 2033 | Method of use | U-1349 | 208400 |
| 11116724 | January 2, 2033 | Method of use | U-1699 | 208400 |
| 11969503 | January 2, 2033 | Drug product | None | 208400 |
| 12396947 | January 2, 2033 | Drug product | None | 208400 |
| 10610485 | January 2, 2033 | Drug product | None | 208400 |
| 9855215 | January 2, 2033 | Drug product | None | 208400 |
| 9259427 | January 2, 2033 | Drug product | None | 208400 |
Xatmep NDC codes
Questions
Is there a generic for Xatmep?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xatmep (methotrexate). The Orange Book shows its last listed patent expires January 2, 2033.
What is the generic name for Xatmep?
The active ingredient in Xatmep is methotrexate, per the FDA Orange Book.
When does the Xatmep patent expire?
The last patent listed for Xatmep in the Orange Book expires January 2, 2033. 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.