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

Atzumi products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
powder, nasalEQ 5.2MG BASEMarketed (Rx)None0None

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

Patents listed for Atzumi
PatentExpiresCoversUse codeNDA
12594273September 24, 2033Drug productNone217901
11872314August 4, 2037Drug productNone217901
10792253August 4, 2037Drug productNone217901
10758532December 11, 2039Drug productNone217901
12263162December 11, 2039Drug productNone217901
12102754October 12, 2041Drug productNone217901
11744967October 12, 2041Drug productNone217901

Atzumi exclusivity

Exclusivity listed for Atzumi
CodeMeaningExpiresNDA
NPNew productApril 30, 2028217901

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.

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