risperidone · Labs Farms Rovi Sa · NDA 214835
Risvan
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 May 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10058504, US 10085936, US 10182982, US 10195138, US 10335366, US 10463607, US 10881605, US 11007139, US 11173110, US 11241377, US 11752092, US 11752093, US 11752094, US 11759416.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10058504 | product | 31 May 2031 |
| US 10085936 | product | 31 May 2031 |
| US 10182982 | use U-3943 | 31 May 2031 |
| US 10195138 | use U-3943 | 31 May 2031 |
| US 10335366 | product | 31 May 2031 |
| US 10463607 | product | 31 May 2031 |
| US 10881605 | product | 31 May 2031 |
| US 11007139 | use U-3942 | 31 May 2031 |
| US 11173110 | use U-3941 | 31 May 2031 |
| US 11241377 | use U-3939 | 31 May 2031 |
| US 11752092 | use U-3941 | 31 May 2031 |
| US 11752093 | product | 31 May 2031 |
| US 11752094 | use U-3942 | 31 May 2031 |
| US 11759416 | use U-3939 | 31 May 2031 |
Exclusivities · 1 unexpired
| NP | new product | 29 Mar 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 |
|---|---|---|---|
| 214835 · 001 · RLD · discontinued | for suspension, extended release, intramuscular | 75MG | 31 May 2031 |
| 214835 · 002 · RLD · discontinued | for suspension, extended release, intramuscular | 100MG | 31 May 2031 |