Orange Book product · Brand (NDA)

ENBUMYST

BUMETANIDE

Brand (NDA)NDA 219500RX CORSTASIS THERAP

Sep 12, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 12, 2025
9 mo ago
Today
Patent 11123319 expires
Listed drug product patent expiration.
Dec 04, 2040
in 14 yr 8 mo
Patent 11260038 expires
Listed method-of-use patent (U-4279) expiration.
Dec 04, 2040
in 14 yr 8 mo
Patent 12329731 expires
Listed drug product patent expiration.
Dec 04, 2040
in 14 yr 8 mo
Patent 12558330 expires
Listed drug product patent expiration.
May 14, 2045
in 19 yr 2 mo

Active ingredient

BUMETANIDE

Strength

0.5MG/SPRAY

Dosage form

SPRAY

Route

NASAL

TE code

Not listed

Application

NDA 219500

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11123319	Dec 04, 2040	in 14 yr 8 mo	Product
11260038	Dec 04, 2040	in 14 yr 8 mo	U-4279
12329731	Dec 04, 2040	in 14 yr 8 mo	ProductU-4279
12558330	May 14, 2045	in 19 yr 2 mo	ProductU-4279