FDA Orange Book
Is there a generic for Trudhesa?
Trudhesa 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 Trudhesa (dihydroergotamine). The Orange Book shows its last listed patent expires January 4, 2039.
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Trudhesa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.725MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 213436, held by IMPEL PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Trudhesa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9550036 | September 5, 2032 | Drug product | None | 213436 |
| 10507295 | December 25, 2032 | Drug product | None | 213436 |
| 10940278 | January 23, 2033 | Drug product | None | 213436 |
| 9919117 | March 17, 2033 | Drug product | U-3218 | 213436 |
| 11266799 | November 5, 2036 | Drug product | None | 213436 |
| 11185497 | January 4, 2039 | Method of use | U-3218 | 213436 |
Trudhesa NDC codes
Questions
Is there a generic for Trudhesa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trudhesa (dihydroergotamine). The Orange Book shows its last listed patent expires January 4, 2039.
What is the generic name for Trudhesa?
The active ingredient in Trudhesa is dihydroergotamine, per the FDA Orange Book.
When does the Trudhesa patent expire?
The last patent listed for Trudhesa in the Orange Book expires January 4, 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.
More on Trudhesa 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 AtzumiFDA Orange Book
- Generic for Brekiya (autoinjector)FDA Orange Book
- Generic for MigranalFDA Orange Book
- Ergotamine Derivatives listFDA drug class
- NDC 77530-725Trudhesa NDC record