FDA Orange Book
Is there a generic for Rezlidhia?
Rezlidhia contains olutasidenib. 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 Rezlidhia (olutasidenib). The Orange Book shows its last listed patent expires November 12, 2039 and its last listed exclusivity ends December 1, 2029.
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Rezlidhia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Marketed (Rx) | None | 0 | None |
NDA 215814, held by RIGEL PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rezlidhia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9834539 | September 18, 2035 | Drug substance, Drug product | U-3497 | 215814 |
| 12275715 | September 18, 2035 | Drug substance, Drug product | U-3684 | 215814 |
| 10414752 | September 18, 2035 | Drug product | None | 215814 |
| 10550098 | September 18, 2035 | Drug product | None | 215814 |
| 11498913 | September 18, 2035 | Drug product | None | 215814 |
| 11497743 | May 16, 2039 | Method of use | U-3495 | 215814 |
| 11376246 | May 16, 2039 | Method of use | U-3495 | 215814 |
| 11013734 | May 16, 2039 | Method of use | U-3495 | 215814 |
| 11013733 | May 16, 2039 | Method of use | U-3496 | 215814 |
| 10532047 | May 16, 2039 | Drug substance | None | 215814 |
| 12053463 | May 16, 2039 | Drug substance, Drug product | None | 215814 |
| 10959994 | May 16, 2039 | Drug product | None | 215814 |
| 11738018 | July 17, 2039 | Method of use | U-3684 | 215814 |
| 11723905 | November 12, 2039 | Drug product | None | 215814 |
Rezlidhia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 1, 2027 | 215814 |
| ODE-413 | Orphan drug exclusivity | December 1, 2029 | 215814 |
Rezlidhia NDC codes
Questions
Is there a generic for Rezlidhia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rezlidhia (olutasidenib). The Orange Book shows its last listed patent expires November 12, 2039 and its last listed exclusivity ends December 1, 2029.
What is the generic name for Rezlidhia?
The active ingredient in Rezlidhia is olutasidenib, per the FDA Orange Book.
When does the Rezlidhia patent expire?
The last patent listed for Rezlidhia in the Orange Book expires November 12, 2039. 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.