FDA Orange Book
Is there a generic for Atzumi?
Atzumi 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 Atzumi (dihydroergotamine). The Orange Book shows its last listed patent expires October 12, 2041 and its last listed exclusivity ends April 30, 2028.
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Atzumi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, nasal | EQ 5.2MG BASE | Marketed (Rx) | None | 0 | None |
NDA 217901, held by SATSUMA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Atzumi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12594273 | September 24, 2033 | Drug product | None | 217901 |
| 11872314 | August 4, 2037 | Drug product | None | 217901 |
| 10792253 | August 4, 2037 | Drug product | None | 217901 |
| 10758532 | December 11, 2039 | Drug product | None | 217901 |
| 12263162 | December 11, 2039 | Drug product | None | 217901 |
| 12102754 | October 12, 2041 | Drug product | None | 217901 |
| 11744967 | October 12, 2041 | Drug product | None | 217901 |
Atzumi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | April 30, 2028 | 217901 |
Atzumi NDC codes
Questions
Is there a generic for Atzumi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Atzumi (dihydroergotamine). The Orange Book shows its last listed patent expires October 12, 2041 and its last listed exclusivity ends April 30, 2028.
What is the generic name for Atzumi?
The active ingredient in Atzumi is dihydroergotamine, per the FDA Orange Book.
When does the Atzumi patent expire?
The last patent listed for Atzumi in the Orange Book expires October 12, 2041. 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.
More on Atzumi and Dihydroergotamine
- What is Dihydroergotamine used for?FDA label uses
- Is Dihydroergotamine a controlled substance?Federal schedule
- Generic for D.h.e.FDA Orange Book
- Generic for Brekiya (autoinjector)FDA Orange Book
- Generic for MigranalFDA Orange Book
- Generic for TrudhesaFDA Orange Book
- Ergotamine Derivatives listFDA drug class
- NDC 76978-101Atzumi NDC record