FDA Orange Book
Is there a generic for Enbumyst?
Enbumyst contains bumetanide. 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 Enbumyst (bumetanide). The Orange Book shows its last listed patent expires May 14, 2045.
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Enbumyst products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | 0.5MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 219500, held by CORSTASIS THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Enbumyst patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12329731 | December 4, 2040 | Drug product | U-4279 | 219500 |
| 11260038 | December 4, 2040 | Method of use | U-4279 | 219500 |
| 11123319 | December 4, 2040 | Drug product | None | 219500 |
| 12558330 | May 14, 2045 | Drug product | U-4279 | 219500 |
Enbumyst NDC codes
Questions
Is there a generic for Enbumyst?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Enbumyst (bumetanide). The Orange Book shows its last listed patent expires May 14, 2045.
What is the generic name for Enbumyst?
The active ingredient in Enbumyst is bumetanide, per the FDA Orange Book.
When does the Enbumyst patent expire?
The last patent listed for Enbumyst in the Orange Book expires May 14, 2045. 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.