remimazolam besylate · Acacia · NDA 212295
Byfavo
Earliest generic entry, as listed
13 Jan 2034
Blocked by patent: US 9827251. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9827251 | use U-2968 · sets the listed date | 13 Jan 2034 |
| US 9561236 | use U-2968 | 30 Apr 2033 |
| US 10052334 | use U-2968 | 7 Nov 2031 |
| US 10195210 | use U-2968 | 7 Nov 2031 |
| US 10342800 | use U-2968 | 7 Nov 2031 |
| US 10722522 | use U-2968 | 7 Nov 2031 |
| US 9737547 | use U-2968 | 7 Nov 2031 |
| US 10472365 | use U-2968 | 10 Jul 2027 |
| US 10961250 | drug product, use U-2968 | 10 Jul 2027 |
| US 9777007 | drug product | 10 Jul 2027 |
| US 9914738 | drug product | 10 Jul 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 212295 · 001 · RLD | powder, intravenous | EQ 20MG BASE/VIAL | 13 Jan 2034 |