dihydroergotamine mesylate · Amneal · NDA 215400
Brekiya (Autoinjector)
Earliest generic entry, as listed
24 Aug 2039
Blocked by patent: US 12414941.
Listed patents · 8 unexpired
11 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12414941 | drug product · sets the listed date | 24 Aug 2039 |
| US 11083712 | drug product, use U-2718, U-4508 | 30 Jun 2039 |
| US 11083712 listing row | drug product, use U-2718 | 30 Jun 2039 |
| US 11083712 listing row | drug product, use U-4508 | 30 Jun 2039 |
| US 12329749 | drug product, use U-2718, U-4508 | 27 May 2039 |
| US 12329749 listing row | drug product, use U-2718 | 27 May 2039 |
| US 12329749 listing row | drug product, use U-4508 | 27 May 2039 |
| US 11541043 | drug product | 20 Mar 2039 |
| US 10532049 | drug product | 26 Feb 2039 |
| US 11304942 | drug product | 26 Feb 2039 |
| US 11819501 | use U-4188, U-848 | 26 Feb 2039 |
| US 11819501 listing row | use U-4188 | 26 Feb 2039 |
| US 11819501 listing row | use U-848 | 26 Feb 2039 |
| US 12533351 | drug product | 26 Feb 2039 |
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 |
|---|---|---|---|
| 215400 · 001 · RLD | solution, subcutaneous | 1MG/ML | 24 Aug 2039 |