revumenib citrate · Syndax · NDA 218944
Revuforj
Earliest generic entry, as listed · earliest of 3 marketed strengths
18 Dec 2042
Blocked by patent: US 12564590.
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12564590 | drug product, use U-4045, U-4327 | 18 Dec 2042 |
| US 12564590 listing row | drug product, use U-4045 · sets the listed date | 18 Dec 2042 |
| US 12564590 listing row | drug product, use U-4327 · sets the listed date | 18 Dec 2042 |
| US 10683302 | drug substance, drug product | 8 Jun 2037 |
| US 11479557 | drug product, use U-4045, U-4327 | 8 Jun 2037 |
| US 11479557 listing row | drug product, use U-4045 | 8 Jun 2037 |
| US 11479557 listing row | drug product, use U-4327 | 8 Jun 2037 |
Exclusivities · 4 unexpired
| ODE-505 | orphan drug (7 years) | 15 Nov 2031 |
| ODE-502 | orphan drug (7 years) | 15 Nov 2031 |
| ODE-504 | orphan drug (7 years) | 15 Nov 2031 |
| NCE | new chemical entity (5 years) | 15 Nov 2029 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218944 · 001 · RLD | tablet, oral | EQ 25MG BASE | 18 Dec 2042 |
| 218944 · 002 · RLD | tablet, oral | EQ 110MG BASE | 18 Dec 2042 |
| 218944 · 003 · RLD | tablet, oral | EQ 160MG BASE | 18 Dec 2042 |