palovarotene · Ipsen · NDA 215559
Sohonos
Earliest generic entry, as listed · earliest of 4 marketed strengths
16 Aug 2037
Blocked by patent: US 10864194. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10864194 | use U-3676 | 16 Aug 2037 |
| US 11622959 | use U-3676 | 8 Jun 2037 |
| US 12138245 | use U-4031 | 8 Jun 2037 |
| US 12201614 | use U-4031 | 8 Jun 2037 |
| US 12458626 | use U-3676 | 8 Jun 2037 |
| US 10292954 | use U-3676 | 31 Aug 2031 |
| US 12023312 | use U-3966 | 31 Aug 2031 |
| US 9314439 | use U-3676 | 31 Aug 2031 |
| US 9789074 | use U-3676 | 31 Aug 2031 |
Exclusivities · 2 unexpired
| ODE-439 | orphan drug (7 years) | 16 Aug 2030 |
| NCE | new chemical entity (5 years) | 16 Aug 2028 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215559 · 001 · RLD | capsule, oral | 1MG | 16 Aug 2037 |
| 215559 · 002 · RLD | capsule, oral | 1.5MG | 16 Aug 2037 |
| 215559 · 003 · RLD · discontinued | capsule, oral | 2.5MG | 16 Aug 2037 |
| 215559 · 004 · RLD | capsule, oral | 5MG | 16 Aug 2037 |
| 215559 · 005 · RLD | capsule, oral | 10MG | 16 Aug 2037 |