edaravone · Shionogi · NDA 215446
Radicava Ors
Earliest generic entry, as listed
12 Nov 2041
Blocked by patent: US 12194025, US 12310946, US 12478611, US 12527769, US 12569469. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12194025 | use U-4111 · sets the listed date | 12 Nov 2041 |
| US 12310946 | use U-4111 · sets the listed date | 12 Nov 2041 |
| US 12478611 | use U-4111 · sets the listed date | 12 Nov 2041 |
| US 12527769 | use U-4111 · sets the listed date | 12 Nov 2041 |
| US 12569469 | use U-4111 · sets the listed date | 12 Nov 2041 |
| US 10987341 | drug product | 1 Nov 2039 |
| US 11241416 | drug product | 1 Nov 2039 |
| US 11478450 | use U-3468 | 1 Nov 2039 |
| US 11826352 | drug product | 1 Nov 2039 |
| US 11957660 | drug product | 1 Nov 2039 |
| US 12285409 | drug product | 1 Nov 2039 |
| US 12599586 | drug product | 1 Nov 2039 |
Exclusivities · 1 unexpired
| ODE-144 | orphan drug (7 years) | 12 May 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215446 · 001 · RLD | suspension, oral | 105MG/5ML | 12 Nov 2041 |