FDA Orange Book
Is there a generic for Brekiya (autoinjector)?
Brekiya (autoinjector) contains dihydroergotamine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brekiya (autoinjector) (dihydroergotamine). The Orange Book shows its last listed patent expires August 24, 2039.
Run it in Rivvi
Map Brekiya (autoinjector) and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Brekiya (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 1MG/ML | Marketed (Rx) | None | 0 | None |
NDA 215400, held by AMNEAL PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Brekiya (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11819501 | February 26, 2039 | Method of use | U-848 | 215400 |
| 11819501 | February 26, 2039 | Method of use | U-4188 | 215400 |
| 10532049 | February 26, 2039 | Drug product | None | 215400 |
| 12533351 | February 26, 2039 | Drug product | None | 215400 |
| 11304942 | February 26, 2039 | Drug product | None | 215400 |
| 11541043 | March 20, 2039 | Drug product | None | 215400 |
| 12329749 | May 27, 2039 | Drug product | U-2718 | 215400 |
| 12329749 | May 27, 2039 | Drug product | U-4508 | 215400 |
| 11083712 | June 30, 2039 | Drug product | U-2718 | 215400 |
| 11083712 | June 30, 2039 | Drug product | U-4508 | 215400 |
| 12414941 | August 24, 2039 | Drug product | None | 215400 |
Brekiya (autoinjector) NDC codes
Questions
Is there a generic for Brekiya (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brekiya (autoinjector) (dihydroergotamine). The Orange Book shows its last listed patent expires August 24, 2039.
What is the generic name for Brekiya (autoinjector)?
The active ingredient in Brekiya (autoinjector) is dihydroergotamine, per the FDA Orange Book.
When does the Brekiya (autoinjector) patent expire?
The last patent listed for Brekiya (autoinjector) in the Orange Book expires August 24, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.