FDA Orange Book
Is there a generic for Xospata?
Xospata contains gilteritinib. 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 Xospata (gilteritinib). The Orange Book shows its last listed patent expires July 1, 2036.
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Xospata products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | None | 0 | None |
NDA 211349, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xospata patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9487491 | July 28, 2030 | Method of use | U-2456 | 211349 |
| 8969336 | November 28, 2032 | Drug substance, Drug product | None | 211349 |
| 11938133 | July 1, 2036 | Drug product | None | 211349 |
| 11944620 | July 1, 2036 | Drug product | None | 211349 |
| 11938130 | July 1, 2036 | Drug product | None | 211349 |
| 10786500 | July 1, 2036 | Drug product | None | 211349 |
| 11938131 | July 1, 2036 | Drug product | None | 211349 |
| 11938132 | July 1, 2036 | Drug product | None | 211349 |
Xospata NDC codes
Questions
Is there a generic for Xospata?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xospata (gilteritinib). The Orange Book shows its last listed patent expires July 1, 2036.
What is the generic name for Xospata?
The active ingredient in Xospata is gilteritinib, per the FDA Orange Book.
When does the Xospata patent expire?
The last patent listed for Xospata in the Orange Book expires July 1, 2036. 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.