vorasidenib · Servier · NDA 218784
Voranigo
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Jan 2039
Blocked by patent: US 11345677.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11345677 | drug substance, drug product, use U-3978 · sets the listed date | 16 Jan 2039 |
| US 11844758 | use U-3977 | 4 Dec 2035 |
| US 10172864 | drug substance, drug product | 11 Jul 2034 |
| US 12433895 | use U-4286 | 11 Jul 2034 |
| US 9579324 | drug substance | 11 Jul 2034 |
Exclusivities · 2 unexpired
| ODE-491 | orphan drug (7 years) | 6 Aug 2031 |
| NCE | new chemical entity (5 years) | 6 Aug 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218784 · 001 · RLD | tablet, oral | 10MG | 16 Jan 2039 |
| 218784 · 002 · RLD | tablet, oral | 40MG | 16 Jan 2039 |