FDA Orange Book · active-ingredient family
Dihydroergotamine mesylate
Dihydroergotamine mesylate is approved as 5 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BREKIYA (AUTOINJECTOR) · NDA 215400
5
Brand (NDA)
13
Generics (ANDA)
21
Listed patents
1
Exclusivity periods
Brand (NDA) products · injectable, powder, solution, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BREKIYA (AUTOINJECTOR)RLD | AMNEAL | NDA 215400 | — | May 14, 2025 | |
| ATZUMIRLD | SATSUMA PHARMS | NDA 217901 | — | Apr 30, 2025 | |
| TRUDHESARLD | IMPEL PHARMS | NDA 213436 | — | Sep 02, 2021 | |
| MIGRANALRLD | BAUSCH | NDA 020148 | AB | Dec 08, 1997 | |
| D.H.E. 45RLD | BAUSCH | NDA 005929 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIHYDROERGOTAMINE MESYLATE | SOMERSET THERAPS LLC | ANDA 215228 | AB | Feb 26, 2025 | |
| DIHYDROERGOTAMINE MESYLATE | BAXTER HLTHCARE CORP | ANDA 216747 | — | Jan 07, 2025 | |
| DIHYDROERGOTAMINE MESYLATE | CIPLA | ANDA 212334 | — | Sep 20, 2024 | |
| DIHYDROERGOTAMINE MESYLATE | GLAND | ANDA 215623 | AP | Aug 18, 2023 | |
| DIHYDROERGOTAMINE MESYLATE | RUBICON RESEARCH | ANDA 216881 | AB | Jun 22, 2023 | |
| DIHYDROERGOTAMINE MESYLATE | AMNEAL | ANDA 214105 | — | Jan 04, 2022 | |
| DIHYDROERGOTAMINE MESYLATE | CIPLA | ANDA 212907 | AB | May 20, 2020 | |
| DIHYDROERGOTAMINE MESYLATE | HIKMA | ANDA 211393 | AB | Feb 28, 2020 | |
| DIHYDROERGOTAMINE MESYLATE | MILLA PHARMS | ANDA 212046 | AP | Jan 07, 2020 | |
| DIHYDROERGOTAMINE MESYLATE | SAGENT PHARMS INC | ANDA 207264 | AP | Jul 11, 2018 | |
| DIHYDROERGOTAMINE MESYLATE | HIKMA PHARMS | ANDA 206621 | AP | Sep 15, 2017 | |
| DIHYDROERGOTAMINE MESYLATE | HIKMA | ANDA 040453 | AP | Jun 09, 2003 | |
| DIHYDROERGOTAMINE MESYLATE | PADAGIS US | ANDA 040475 | — | Apr 28, 2003 |
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Apr 30, 2028
in 1 yr 11 mo
Listed patents (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9550036 | Sep 05, 2032 | in 6 yr 4 mo | Product |
| 10507295 | Dec 25, 2032 | in 6 yr 7 mo | Product |
| 10940278 | Jan 23, 2033 | in 6 yr 8 mo | Product |
| 9919117 | Mar 17, 2033 | in 6 yr 10 mo | ProductU-3218 |
| 12594273 | Sep 24, 2033 | in 7 yr 4 mo | Product |
| 11266799 | Nov 05, 2036 | in 10 yr 6 mo | Product |
| 11872314 | Aug 04, 2037 | in 11 yr 3 mo | Product |
| 10792253 | Aug 04, 2037 | in 11 yr 3 mo | Product |
| 11185497 | Jan 04, 2039 | in 12 yr 9 mo | U-3218 |
| 11819501 | Feb 26, 2039 | in 12 yr 11 mo | U-848 |
| 10532049 | Feb 26, 2039 | in 12 yr 11 mo | Product |
| 12533351 | Feb 26, 2039 | in 12 yr 11 mo | Product |
| 11304942 | 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 |
| 11083712 | Jun 30, 2039 | in 13 yr 3 mo | ProductU-2718 |
| 12414941 | Aug 24, 2039 | in 13 yr 4 mo | Product |
| 10758532 | Dec 11, 2039 | in 13 yr 8 mo | Product |
| 12263162 | Dec 11, 2039 | in 13 yr 8 mo | Product |
| 12102754 | Oct 12, 2041 | in 15 yr 6 mo | Product |
| 11744967 | Oct 12, 2041 | in 15 yr 6 mo | Product |
Dihydroergotamine mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
