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Last Updated: April 18, 2024

Bumetanide - Generic Drug Details

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What are the generic drug sources for bumetanide and what is the scope of patent protection?

Bumetanide is the generic ingredient in two branded drugs marketed by Gland Pharma Ltd, Hospira, MSN, Sagent, Teva Parenteral, West-ward Pharms Int, Validus Pharms, Amneal Pharms Co, Heritage Pharma, Rising, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for bumetanide. Twenty-six suppliers are listed for this compound.

Summary for bumetanide

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	16
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	28
Patent Applications:	6,660
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for bumetanide
Drug Sales Revenues:	Drug sales revenues for bumetanide
What excipients (inactive ingredients) are in bumetanide?	bumetanide excipients list
DailyMed Link:	bumetanide at DailyMed

See drug prices for bumetanide

Drug Sales Revenue Trends for bumetanide

See drug sales revenues for bumetanide

Recent Clinical Trials for bumetanide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yale University	Phase 1
Vrije Universiteit Brussel	Phase 4
Roche Diagnostics	Phase 4

See all bumetanide clinical trials

Pharmacology for bumetanide

Drug Class	Loop Diuretic
Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for bumetanide

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for bumetanide

C03CA	Sulfonamides, plain
C03C	HIGH-CEILING DIURETICS
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for bumetanide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	BUMEX	bumetanide	INJECTABLE;INJECTION	018226-001	Feb 28, 1983		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	BUMETANIDE	bumetanide	TABLET;ORAL	209916-002	Jan 23, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gland Pharma Ltd	BUMETANIDE	bumetanide	INJECTABLE;INJECTION	216434-001	May 26, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	BUMETANIDE	bumetanide	TABLET;ORAL	213458-001	Jul 24, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for bumetanide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-002	Feb 28, 1983	⤷ Try a Trial	⤷ Try a Trial
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-002	Feb 28, 1983	⤷ Try a Trial	⤷ Try a Trial
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-001	Feb 28, 1983	⤷ Try a Trial	⤷ Try a Trial
Validus Pharms	BUMEX	bumetanide	INJECTABLE;INJECTION	018226-001	Feb 28, 1983	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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