azacitidine · Bristol · NDA 214120
Onureg
Earliest generic entry, as listed · earliest of 2 marketed strengths
3 Jun 2030
Blocked by patent: US 8846628.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8846628 | drug product, use U-2950 · sets the listed date | 3 Jun 2030 |
| US 11571436 | drug product | 14 May 2029 |
| US 12053482 | use U-2950 | 14 May 2029 |
Exclusivities · 1 unexpired
| ODE-320 | orphan drug (7 years) | 1 Sep 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214120 · 001 · RLD | tablet, oral | 200MG | 3 Jun 2030 |
| 214120 · 002 · RLD | tablet, oral | 300MG | 3 Jun 2030 |