Orange Book product · Brand (NDA)
BREKIYA (AUTOINJECTOR)
DIHYDROERGOTAMINE MESYLATE
At a glance
May 14, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 14, 2025
1 yr 1 mo ago
Today
Patent 10532049 expires
Listed drug product patent expiration.
Feb 26, 2039
in 12 yr 11 mo
Patent 11304942 expires
Listed drug product patent expiration.
Feb 26, 2039
in 12 yr 11 mo
Patent 11819501 expires
Listed method-of-use patent (U-848) expiration.
Feb 26, 2039
in 12 yr 11 mo
Patent 11819501 expires
Listed method-of-use patent (U-4188) expiration.
Feb 26, 2039
in 12 yr 11 mo
Patent 12533351 expires
Listed drug product patent expiration.
Feb 26, 2039
in 12 yr 11 mo
Patent 11541043 expires
Listed drug product patent expiration.
Mar 20, 2039
in 12 yr 11 mo
Patent 12329749 expires
Listed drug product patent expiration.
May 27, 2039
in 13 yr 2 mo
Patent 12329749 expires
Listed drug product patent expiration.
May 27, 2039
in 13 yr 2 mo
Patent 11083712 expires
Listed drug product patent expiration.
Jun 30, 2039
in 13 yr 3 mo
Patent 11083712 expires
Listed drug product patent expiration.
Jun 30, 2039
in 13 yr 3 mo
Patent 12414941 expires
Listed drug product patent expiration.
Aug 24, 2039
in 13 yr 4 mo
Pharmaceutical detail
Active ingredient
DIHYDROERGOTAMINE MESYLATE
Strength
1MG/ML
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 215400
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025ATZUMIBrand (NDA)
NDA 217901 · SATSUMA PHARMS
- 2021TRUDHESABrand (NDA)
NDA 213436 · IMPEL PHARMS
- 1997MIGRANALBrand (NDA)
NDA 020148 · BAUSCH
- —D.H.E. 45Brand (NDA)
NDA 005929 · BAUSCH
- 2025DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 215228 · SOMERSET THERAPS LLC
- 2025DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 216747 · BAXTER HLTHCARE CORP
- 2024DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 212334 · CIPLA
- 2023DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 215623 · GLAND
- 2023DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 216881 · RUBICON RESEARCH
- 2022DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 214105 · AMNEAL
- 2020DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 212907 · CIPLA
- 2020DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 211393 · HIKMA
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10532049 | Feb 26, 2039 | in 12 yr 11 mo | Product |
| 11304942 | Feb 26, 2039 | in 12 yr 11 mo | Product |
| 11819501 | Feb 26, 2039 | in 12 yr 11 mo | U-848 |
| 11819501 | Feb 26, 2039 | in 12 yr 11 mo | U-4188 |
| 12533351 | Feb 26, 2039 | in 12 yr 11 mo | Product |
| 11541043 | Mar 20, 2039 | in 12 yr 11 mo | Product |
| 12329749 | May 27, 2039 | in 13 yr 2 mo | ProductU-2718 |
| 12329749 | May 27, 2039 | in 13 yr 2 mo | ProductU-4508 |
| 11083712 | Jun 30, 2039 | in 13 yr 3 mo | ProductU-2718 |
| 11083712 | Jun 30, 2039 | in 13 yr 3 mo | ProductU-4508 |
| 12414941 | Aug 24, 2039 | in 13 yr 4 mo | Product |
