FDA Orange Book
Is there a generic for Onureg?
Onureg contains azacitidine. 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 Onureg (azacitidine). The Orange Book shows its last listed patent expires June 3, 2030 and its last listed exclusivity ends September 1, 2027.
Run it in Rivvi
Map Onureg and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Onureg products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 300MG | Marketed (Rx) | None | 0 | None |
NDA 214120, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Onureg patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12053482 | May 14, 2029 | Method of use | U-2950 | 214120 |
| 11571436 | May 14, 2029 | Drug product | None | 214120 |
| 8846628 | June 3, 2030 | Drug product | U-2950 | 214120 |
Onureg exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-320 | Orphan drug exclusivity | September 1, 2027 | 214120 |
Onureg NDC codes
Questions
Is there a generic for Onureg?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Onureg (azacitidine). The Orange Book shows its last listed patent expires June 3, 2030 and its last listed exclusivity ends September 1, 2027.
What is the generic name for Onureg?
The active ingredient in Onureg is azacitidine, per the FDA Orange Book.
When does the Onureg patent expire?
The last patent listed for Onureg in the Orange Book expires June 3, 2030. 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.