FDA Orange Book
Is there a generic for Inqovi?
Inqovi contains cedazuridine and decitabine. 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 Inqovi (cedazuridine and decitabine). The Orange Book shows its last listed patent expires December 10, 2042 and its last listed exclusivity ends May 13, 2029.
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Inqovi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG;35MG | Marketed (Rx) | None | 0 | None |
NDA 212576, held by TAIHO ONCOLOGY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Inqovi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8618075 | October 16, 2028 | Method of use | U-2864 | 212576 |
| 8618075 | October 16, 2028 | Method of use | U-2867 | 212576 |
| 9567363 | October 16, 2028 | Drug substance | None | 212576 |
| 8268800 | February 12, 2034 | Drug substance | U-2866 | 212576 |
| 8268800 | February 12, 2034 | Drug substance | U-2865 | 212576 |
| 8268800 | February 12, 2034 | Drug substance | U-2864 | 212576 |
| 8268800 | February 12, 2034 | Drug substance | U-2867 | 212576 |
| 12195496 | October 7, 2040 | Drug product | None | 212576 |
| 12239653 | February 24, 2041 | Method of use | U-2865 | 212576 |
| 12239653 | February 24, 2041 | Method of use | U-2866 | 212576 |
| 11963971 | February 24, 2041 | Drug product | None | 212576 |
| 12697347 | December 10, 2042 | Method of use | U-4587 | 212576 |
Inqovi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-316 | Orphan drug exclusivity | July 7, 2027 | 212576 |
| I-990 | New indication | May 13, 2029 | 212576 |
Inqovi NDC codes
Questions
Is there a generic for Inqovi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inqovi (cedazuridine and decitabine). The Orange Book shows its last listed patent expires December 10, 2042 and its last listed exclusivity ends May 13, 2029.
What is the generic name for Inqovi?
The active ingredient in Inqovi is cedazuridine and decitabine, per the FDA Orange Book.
When does the Inqovi patent expire?
The last patent listed for Inqovi in the Orange Book expires December 10, 2042. 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.