FDA Orange Book
Is there a generic for Komzifti?
Komzifti contains ziftomenib. 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 Komzifti (ziftomenib). The Orange Book shows its last listed patent expires July 16, 2044 and its last listed exclusivity ends November 13, 2030.
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Komzifti products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Marketed (Rx) | None | 0 | None |
NDA 220305, held by KURA ONCOLOGY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Komzifti patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10174041 | March 16, 2036 | Method of use | U-4350 | 220305 |
| 10174041 | March 16, 2036 | Method of use | U-4354 | 220305 |
| 10077271 | March 16, 2036 | Drug substance, Drug product | None | 220305 |
| 10869868 | January 26, 2037 | Method of use | U-4352 | 220305 |
| 10869868 | January 26, 2037 | Method of use | U-4353 | 220305 |
| 11673898 | March 15, 2037 | Method of use | U-4350 | 220305 |
| 11673898 | March 15, 2037 | Method of use | U-4351 | 220305 |
| 10781218 | March 15, 2037 | Drug substance, Drug product | None | 220305 |
| 11944627 | September 6, 2038 | Method of use | U-4347 | 220305 |
| 11944627 | September 6, 2038 | Method of use | U-4349 | 220305 |
| 12410184 | July 16, 2044 | Drug substance, Drug product | U-4347 | 220305 |
| 12410184 | July 16, 2044 | Drug substance, Drug product | U-4348 | 220305 |
| 12521396 | July 16, 2044 | Drug product | None | 220305 |
Komzifti exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 13, 2030 | 220305 |
Komzifti NDC codes
Questions
Is there a generic for Komzifti?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Komzifti (ziftomenib). The Orange Book shows its last listed patent expires July 16, 2044 and its last listed exclusivity ends November 13, 2030.
What is the generic name for Komzifti?
The active ingredient in Komzifti is ziftomenib, per the FDA Orange Book.
When does the Komzifti patent expire?
The last patent listed for Komzifti in the Orange Book expires July 16, 2044. 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.