BUMEX Drug Patent Profile

Which patents cover Bumex, and when can generic versions of Bumex launch?

Bumex is a drug marketed by Validus Pharms and is included in two NDAs.

The generic ingredient in BUMEX is bumetanide. There are six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bumex

A generic version of BUMEX was approved as bumetanide by SAGENT on January 27^th, 1995.

Summary for BUMEX

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	5,232
What excipients (inactive ingredients) are in BUMEX?	BUMEX excipients list
DailyMed Link:	BUMEX at DailyMed

Pharmacology for BUMEX

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

US Patents and Regulatory Information for BUMEX

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
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985	AB	RX	Yes	No
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-002	Feb 28, 1983	AB	RX	Yes	No

Expired US Patents for BUMEX

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	018225-003	Jun 14, 1985

International Patents for BUMEX

See the table below for patents covering BUMEX around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	697	New sulphamyl-benzoic acid derivatives
Belgium	743744
Japan	S5420483

Market Dynamics and Financial Trajectory for BUMEX

Last updated: July 29, 2025

Overview

BUMEX, known generically as bumetanide, is a potent loop diuretic primarily used to treat edema associated with congestive heart failure, liver cirrhosis, and renal disorders. Its unique pharmacological profile and clinical utility have positioned BUMEX within a competitive landscape characterized by evolving regulatory, therapeutic, and market forces. This analysis explores the key market dynamics shaping BUMEX's trajectory and offers an outlook on its financial prospects.

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Pharmacological Profile and Clinical Utility

BUMEX's mechanism as a potent loop diuretic functions by inhibiting the sodium-potassium-chloride symporter in the thick ascending limb of Henle's loop. Its high potency allows for rapid diuresis, making it a preferred choice in acute settings. Compared to furosemide, BUMEX exhibits approximately 40% higher bioavailability, enabling effective management of refractory edema.

Clinicians’ increasing interest in BUMEX derives from its efficacy in patients with diuretic resistance, a common challenge in managing heart failure. However, safety concerns over electrolyte imbalances, dehydration, and ototoxicity limit its widespread chronic use, placing it primarily in hospital settings.

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Market Size and Growth Drivers

Global Diuretics Market

The global diuretics market was valued at around USD 7.2 billion in 2022 and is projected to grow at a CAGR of approximately 4.5% through 2030 ([1]). Bumetanide's share remains modest but significant owing to its specific clinical niche.

Therapeutic Demand Drivers

• Rising Cardiovascular Disease (CVD) Burden: According to WHO, CVD accounts for an estimated 17.9 million deaths annually, fueling demand for effective diuretics like BUMEX for symptomatic relief.
• Chronic Heart Failure (CHF) Incidence: The increasing prevalence of CHF, expected to reach 26 million cases globally by 2030, supports sustained demand for diuretics ([2]).
• Hospitalization Trends: The shift towards hospital-based acute management, especially in severe edema and decompensated heart failure, enhances BUMEX's utilization.

Regional Market Dynamics

• North America: Dominates due to advanced healthcare infrastructure, high CVD prevalence, and robust hospital systems.
• Europe: Also significant, driven by aging populations and established healthcare protocols.
• Asia-Pacific: Projected rapid growth owing to increasing CVD cases, rising healthcare investments, and expanding hospital networks.

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Regulatory and Patent Outlook

BUMEX lacks recent patent protection, as its original patents expired decades ago, resulting in a highly competitive generics market. The absence of patent exclusivity limits pricing power but fosters market penetration through lower-cost options.

Regulatory pathways are well-established, with BUMEX approved globally. Yet, new formulations or delivery mechanisms—like sustained-release versions—could offer differentiation.

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Competitive Landscape

Key Competitors

While bumetanide competes with other loop diuretics, its primary challengers include:

• Furosemide: Widely used, cost-effective, with a larger market share.
• Torasemide and Ethacrynic Acid: Alternative loop diuretics with varying efficacy and safety profiles.

Innovative Opportunities

Research into combining BUMEX with other agents or developing novel delivery systems to optimize bioavailability and reduce adverse effects presents potential growth avenues.

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Pricing and Reimbursement Dynamics

Being a generic drug, BUMEX’s pricing is predominantly driven by market competition. Cost-effectiveness remains pivotal for hospital formularies and reimbursement policies. Payers favor drugs that demonstrate clinical efficacy with minimized adverse events to reduce overall healthcare cost burdens.

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Emerging Trends and Challenges

Personalized Medicine

The integration of biomarkers and pharmacogenomics could optimize bumetanide dosing, improving safety and efficacy in diverse populations.

Regulatory Challenges

Ensuring consistent quality standards, especially for generics manufactured across regions with varying regulations, remains critical.

Supply Chain Considerations

Global supply disruptions impact availability and pricing, emphasizing the need for diversified manufacturing sources.

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Financial Trajectory and Investment Outlook

Given the mature status of BUMEX within the diuretics market, its revenue prospects hinge on factors such as:

• Volume-based growth driven by increasing disease prevalence.
• Market penetration in emerging economies.
• Potential off-label uses or combination therapies.

Investors should consider the compound's limited profitability due to its patent expiration but acknowledge opportunities from expanding therapeutic indications and incremental formulations.

Forecast Summary

• Revenue Growth: Moderate, aligned with general diuretic market expansion.
• Profit Margins: Stabilized but thin due to price competition.
• Strategic Opportunities: Focus on differentiation via formulations or targeting niche indications.

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Key Market Risks

• Pricing Pressure: Intense generic competition suppresses margins.
• Regulatory Changes: New safety standards could restrict usage.
• Market Saturation: Limited scope for volume expansion in mature markets.

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Conclusion

BUMEX is characterized by steady, niche-market demand within the broader diuretics sector. Its financial trajectory mirrors the growth patterns of global cardiovascular disease burden, with regional variances influenced by healthcare infrastructure and regulatory landscapes. Innovating through formulations or clinical applications may unlock incremental growth, but the fundamental market remains driven by volume and cost considerations amidst fierce generic competition.

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Key Takeaways

• The global demand for BUMEX aligns with rising cardiovascular disease and congestive heart failure cases.
• Market growth is moderate, contingent on regional healthcare developments and hospital-based protocols.
• Patent expirations limit pricing power; however, cost advantages bolster generics' competitiveness.
• Opportunities exist in developing targeted formulations and exploring new therapeutic niches.
• Competition and regulatory pressures necessitate strategic positioning centered on efficacy, safety, and cost-efficiency.

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FAQs

1. What differentiates BUMEX from other loop diuretics?
   Bumetanide exhibits approximately 40% higher oral bioavailability than furosemide, leading to more rapid and predictable diuresis, especially in patients with diuretic resistance. Its potency permits lower dosing and potentially fewer adverse effects.

2. What are the main challenges facing BUMEX in the current market?
   The primary challenges include intense price competition from generics, safety concerns related to electrolyte imbalance, and limited patent protection, which compresses profit margins.

3. Are there any emerging therapeutic uses for BUMEX?
   Research focuses on its potential in neurodegenerative disorders due to bumetanide's ability to modulate intracellular chloride levels affecting neuronal excitability. Such applications are experimental and not yet in mainstream clinical practice.

4. How does regional variation impact BUMEX's market prospects?
   Developed markets (North America, Europe) offer stable demand driven by high healthcare standards, whereas emerging markets present growth opportunities fueled by rising CVD prevalence and expanding healthcare access.

5. What strategies could enhance BUMEX’s financial outlook?
   Developing novel formulations, expanding into niche indications, and optimizing supply chain efficiencies can bolster revenue streams despite competitive pressures.

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Sources:

1. Market Research Future. (2022). Global Diuretics Market report.
2. WHO. (2021). Global status report on cardiovascular disease.