dexmedetomidine hydrochloride · Bioxcel · NDA 215390
Igalmi
Earliest generic entry, as listed · earliest of 2 marketed strengths
12 Jan 2043
Blocked by patent: US 11806334, US 11998528, US 12090140, US 12138247, US 12364683. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 14 unexpired
15 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11806334 | use U-3725 · sets the listed date | 12 Jan 2043 |
| US 11998528 | use U-3935 · sets the listed date | 12 Jan 2043 |
| US 12090140 | use U-3986 · sets the listed date | 12 Jan 2043 |
| US 12138247 | use U-4029 · sets the listed date | 12 Jan 2043 |
| US 12364683 | use U-4029 · sets the listed date | 12 Jan 2043 |
| US 11890272 | use U-3756, U-3935 | 17 Jul 2040 |
| US 11890272 listing row | use U-3756 | 17 Jul 2040 |
| US 11890272 listing row | use U-3935 | 17 Jul 2040 |
| US 11998529 | use U-3935 | 17 Jul 2040 |
| US 12109196 | use U-3935 | 17 Jul 2040 |
| US 10792246 | drug product, use U-3350 | 26 Jun 2039 |
| US 11478422 | drug product | 26 Jun 2039 |
| US 11497711 | drug product, use U-3645 | 26 Jun 2039 |
| US 11517524 | drug product, use U-3645 | 26 Jun 2039 |
| US 11786508 | use U-3698 | 29 Dec 2037 |
| US 11839604 | use U-3756 | 29 Dec 2037 |
Exclusivities · 1 unexpired
| M-82 | miscellaneous (3 years) | 19 Nov 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 |
|---|---|---|---|
| 215390 · 001 · RLD | film, buccal, sublingual | EQ 0.12MG BASE | 12 Jan 2043 |
| 215390 · 002 · RLD | film, buccal, sublingual | EQ 0.18MG BASE | 12 Jan 2043 |