bumetanide - Profile

What are the generic sources for bumetanide and what is the scope of freedom to operate?

Bumetanide is the generic ingredient in three branded drugs marketed by Aspiro, Gland, Hospira, Lupin Ltd, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Validus Pharms, Corstasis Therap, Amneal Pharms Co, Appco, Heritage Pharma, Jubilant Generics, Mankind Pharma, Rising, Rubicon Research, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in twenty-five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bumetanide has nine patent family members in nine countries.

Summary for bumetanide

International Patents:	9
US Patents:	3
Tradenames:	3
Applicants:	22
NDAs:	25

US Patents and Regulatory Information for bumetanide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspiro	BUMETANIDE	bumetanide	INJECTABLE;INJECTION	218746-001	Feb 27, 2025	AP	RX	No	No
Gland	BUMETANIDE	bumetanide	INJECTABLE;INJECTION	216434-001	May 26, 2022	AP	RX	No	No
Hospira	BUMETANIDE	bumetanide	INJECTABLE;INJECTION	074160-001	Oct 30, 1997		DISCN	No	No

Expired US Patents for bumetanide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985
Validus Pharms	BUMEX	bumetanide	INJECTABLE;INJECTION	018226-001	Feb 28, 1983
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-001	Feb 28, 1983

International Patents for bumetanide

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4069222	PROCÉDÉS ET COMPOSITIONS POUR TRAITER UN OEDÈME RÉFRACTAIRE À DES DIURÉTIQUES ORAUX (METHODS AND COMPOSITIONS FOR TREATING EDEMA REFRACTORY TO ORAL DIURETICS)
Australia	2020397176	Methods and compositions for treating edema refractory to oral diuretics
Israel	293429	שיטות ותכשירים לטיפול בבצקת עמידה למשתנים פומיים (Methods and compositions for treating edema refractory to oral diuretics)

Investment Scenario and Fundamentals Analysis for Bumetanide

Last updated: February 19, 2026

What is Bumetanide?

Bumetanide is a loop diuretic primarily used to treat edema associated with congestive heart failure, liver cirrhosis, and renal disease. It acts by inhibiting sodium-potassium-chloride cotransporters in the renal loop of Henle, leading to increased urine output.

Market Overview

Market Size and Growth

• The global diuretic market was valued at approximately USD 4.8 billion in 2021.
• Expected compound annual growth rate (CAGR): 3-5% over the next five years, driven by aging populations and increasing prevalence of heart failure and edema.
• Bumetanide accounts for a small but growing segment within this market, primarily competing with furosemide and torsemide.

Key Players and Patents

• Main marketed drugs: Bayer's Bumex (original brand), generic manufacturers.
• Patent protection: Original patent expired approximately in 2004; current formulations are off-patent.
• R&D pipelines: No current major proprietary formulations or novel indications in extensive late-stage development for bumetanide.

Sales and Revenue Trends

• Commercial sales mainly derive from generic versions, with limited branded presence outside niche markets.
• Sales in North America and Europe dominate, representing over 70% of global revenue.
• Market penetration is stable, with incremental growth through drug repurposing and off-label uses.

Potential for Repurposing

Emerging Evidence and Indications:

• Neuroprotective effects in neurological diseases such as autism and neonatal seizures.
• Potential use in treating conditions involving ion imbalance, such as stroke or traumatic brain injury.

Patent and Regulatory Status

• No current patents protect bumetanide for new indications.
• Regulatory approval for traditional indications is well-established.

Competitive Landscape

Competitors	Products	Market Share	Patent Status	R&D Focus
Bayer	Bumex	~20%	Patented until 2004	N/A
Generics	Various (e.g., Furosemide)	80%+	Off-patent	Limited
Niche players	Potential repurposed drugs	Small	Off-patent	Exploring new indications

R&D and Innovation

• Limited pipeline-specific to bumetanide.
• Interest in developing formulations with improved bioavailability or targeting central nervous system conditions.

Investment Risks

• Off-patent status diminishes exclusivity, increasing price competition.
• Limited innovation pipeline restricts growth outside expanding off-label uses.
• Regulatory hurdles for new indications could delay or prevent development efforts.

Regulatory Considerations

• US FDA and EMA approvals are established for traditional indications.
• Approval for new uses would require clinical trials, with uncertain timelines and costs.
• Previous safety concerns with diuretics (e.g., electrolyte imbalance) remain relevant.

Conclusion

Investing in bumetanide features limited near-term growth prospects due to patent expiry, generic competition, and minimal innovation pipeline. Opportunities may exist in drug repurposing and niche indications, provided clinical evidence and regulatory pathways align. Risks include low exclusivity and potential market saturation.

Key Takeaways

• Bumetanide is a low-cost, off-patent diuretic with established generic competition.
• Market expansion through new indications depends on clinical validation and regulatory approval.
• The absence of a robust pipeline limits growth outside existing off-label uses.
• Potential exists in neurological indications, but scientific and regulatory challenges persist.
• Investment risk is high due to competition and limited proprietary advantages.

FAQs

1. What are the main indications for bumetanide?
Edema associated with heart failure, liver cirrhosis, and renal diseases.

2. Are there any patents protecting bumetanide for new uses?
No; bumetanide is off-patent, limiting exclusivity for novel indications.

3. Is there ongoing research into new applications for bumetanide?
Yes; studies explore neuroprotective effects and neurological conditions, but no late-stage clinical trials are confirmed.

4. How does generic competition impact the market?
It drives down prices and reduces revenue margins for any remaining branded sales.

5. What are the key regulatory hurdles for repurposing bumetanide?
Need for new clinical trials demonstrating safety and efficacy in new indications, which can be costly and time-consuming.

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References

[1] MarketResearch.com. (2022). Global Diuretics Market Report.
[2] U.S. Food and Drug Administration. (2021). Bumetanide approval documentation.
[3] ClinicalTrials.gov. (2023). Ongoing studies involving bumetanide.