Is there a generic for Bumetanide?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Bumetanide, referencing the brand ENBUMYST. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bumetanide?

ENBUMYST (NDA 219500, CORSTASIS THERAP) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Bumetanide?

The Orange Book lists 4 patents against Bumetanide products, with the earliest listed expiry in 2040. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Bumetanide are approved?

Bumetanide is approved in the following dosage forms: injectable, spray, tablet.

FDA Orange Book · active-ingredient family

Bumetanide

Bumetanide: 3 brands, 23 generics; first approved Feb 28, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 23 ANDA applications approved.

Earliest patent expiry Dec 04, 2040

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 04, 2040

in 14 yr 6 mo

Brand (NDA) products

Originator applications

ENBUMYSTRLDRS
CORSTASIS THERAPNDA 2195002025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG/SPRAY SPRAY NASAL Rx —
BUMEXRLD
VALIDUS PHARMSNDA 0182261983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Discontinued —
BUMEXRLD
VALIDUS PHARMSNDA 01822519833 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/SPRAY	SPRAY	NASAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (23)

Abbreviated applications

BUMETANIDE
ANTHEA PHARMAANDA 2204272026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
MSNANDA 21536220263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
JUBILANT GENERICSANDA 21247020253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
MANKIND PHARMAANDA 21929120253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
ASPIROANDA 2187462025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
RUBICON RESEARCHANDA 21394220243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
QILU PHARM HAINANANDA 2191162024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
APPCOANDA 21293120243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
LUPINANDA 2171532024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
TAROANDA 21345820233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
MSNANDA 2153642022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
GLANDANDA 2164342022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
RISINGANDA 21201920193 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
ZYDUS PHARMSANDA 20290020183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
UPSHER SMITH LABSANDA 20991620183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
AMNEAL PHARMS COANDA 20972420173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDERS
WEST-WARD PHARMS INTANDA 0791962008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
TEVA PARENTERALANDA 0746131997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Discontinued —
BUMETANIDE
HOSPIRAANDA 0741601997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Discontinued —
BUMETANIDE
SANDOZANDA 07470019963 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
HERITAGE PHARMAANDA 07422519953 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
BUMETANIDE
SAGENTANDA 0744411995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Rx AP
BUMETANIDE
HOSPIRAANDA 0743321994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12329731	Dec 04, 2040	in 14 yr 6 mo	ProductU-4279
11260038	Dec 04, 2040	in 14 yr 6 mo	U-4279
11123319	Dec 04, 2040	in 14 yr 6 mo	Product
12558330	May 14, 2045	in 19 yr	ProductU-4279

Approval history

FDA approval span

First approval

Feb 28, 1983

44 yr 1 mo ago

Most recent approval

Feb 26, 2026

6 mo ago

Approvals span 1983–2026 across 26 FDA applications.

Brand (NDA) 312%

Generic (ANDA) 2388%

Bumetanide: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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