sparsentan · Travere · NDA 216403
Filspari
Earliest generic entry, as listed · earliest of 2 marketed strengths
13 Oct 2037
Blocked by patent: US 12714697. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12714697 | use U-3993 | 13 Oct 2037 |
| US 9662312 | use U-4495 | 29 Mar 2030 |
| US 9993461 | use U-4495 | 29 Mar 2030 |
| US 9993461 | use U-3269 | 29 Mar 2030 |
| US 9993461 | use U-3993 | 29 Mar 2030 |
Exclusivities · 4 unexpired
| ODE-493 | orphan drug (7 years) | 5 Sep 2031 |
| ODE-389 | orphan drug (7 years) | 17 Feb 2030 |
| I-989 | new indication (3 years) | 13 Apr 2029 |
| NCE | new chemical entity (5 years) | 17 Feb 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216403 · 001 · RLD | tablet, oral | 200MG | 13 Oct 2037 |
| 216403 · 002 · RLD | tablet, oral | 400MG | 13 Oct 2037 |