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. Twenty-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:	116
Patent Applications:	5,076
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
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-001	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	018225-001	Feb 28, 1983	3,634,583
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985	3,806,534
Validus Pharms	BUMEX	bumetanide	INJECTABLE;INJECTION	018226-001	Feb 28, 1983	3,634,583
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985	3,634,583

International Patents for BUMEX

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

Country	Patent Number	Title	Estimated Expiration
Spain	374688
Brazil	6915200
Ireland	33874	NEW SULPHAMYL-BENZOIC ACID DERIVATIVES
Denmark	134548

BUMEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bumetanide (Bumex)

Introduction to Bumetanide

Bumetanide, commonly known by the brand name Bumex, is a potent loop diuretic used to treat edema associated with congestive heart failure, hepatic and renal disease, and nephrotic syndrome. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The Bumetanide API market is valued at approximately USD 450 million in 2023 and is projected to grow to USD 850 million by 2033, with a Compound Annual Growth Rate (CAGR) of 6% from 2024 to 2033[1].

Key Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The rising prevalence of heart failure and hypertension is a significant driver of the Bumetanide market. As the global population ages and lifestyle-related diseases become more common, the demand for effective diuretic therapies like Bumetanide is expected to increase[1][4].

Therapeutic Versatility

Bumetanide is used in multiple indications, including heart failure, edema, and renal disease. This versatility expands its market potential and makes it a valuable asset in the pharmaceutical portfolio of many companies[1][5].

Regulatory Compliance

Stringent regulatory frameworks ensure the high-quality manufacturing of Bumetanide APIs. Compliance with these regulations is a critical factor in maintaining market trust and ensuring the safety and efficacy of the drug[1].

R&D Investments

Continuous investments in research and development are fostering innovation in Bumetanide formulations. This includes exploring new therapeutic indications and improving existing formulations to enhance patient outcomes[1][4].

Aging Population

The rising elderly demographic is a significant contributor to market growth. Older populations are more likely to suffer from conditions that require diuretic therapy, making Bumetanide a crucial medication in geriatric care[1].

Regional Analysis

North America

North America holds the largest share in the Bumetanide API market, driven by the high prevalence of cardiovascular diseases, advanced healthcare infrastructure, and strong regulatory frameworks. The United States is a significant contributor to this demand, with a large population requiring effective diuretic therapies[1].

Europe

Europe follows closely, with a growing emphasis on evidence-based medicine and increased patient awareness regarding heart health. Countries like Germany, France, and the UK are major markets for Bumetanide APIs, driven by the rising incidence of heart failure and related conditions[1].

Asia-Pacific

The Asia-Pacific region is emerging as a significant growth area for the Bumetanide API market. Rapid urbanization, increasing disposable incomes, and the rising prevalence of lifestyle-related diseases contribute to the growing demand for effective therapeutic agents. Countries such as China and India are witnessing a surge in healthcare expenditures, leading to improved access to medicines and driving demand for Bumetanide[1].

Latin America and Middle East & Africa

These regions present smaller but promising markets for Bumetanide APIs. The ongoing improvement in healthcare infrastructure and rising awareness about chronic diseases are expected to drive demand in these areas[1].

Competitive Landscape

The Bumetanide market is characterized by a mix of established players and new entrants. Leading players include Teva Pharmaceuticals, Sun Pharmaceutical Industries, and Mylan. These companies compete based on factors such as product quality, safety, efficacy, pricing, regulatory compliance, and distribution networks to gain market share and maintain a competitive edge[1][4].

Financial Trajectory

Revenue Growth

The projected growth of the Bumetanide API market from USD 450 million in 2023 to USD 850 million by 2033 indicates a robust financial trajectory. This growth is driven by increasing demand, expanding markets in emerging economies, and continuous innovation in formulations[1].

Pricing Dynamics

The cost of Bumetanide varies depending on the dosage and form. For example, a 2 mg tablet of Bumex can cost around USD 1.65, while a generic 2 mg tablet of Bumetanide can cost approximately USD 1.04[5].

Market Opportunities

• Expanded Indications: Exploring new therapeutic indications for Bumetanide, such as acute decompensated heart failure, liver cirrhosis, and acute kidney injury, presents opportunities for market expansion and revenue growth[4].
• Emerging Markets: Penetrating emerging markets in Asia, Latin America, and Africa offers growth opportunities due to increasing healthcare spending and rising prevalence of chronic diseases[4].

Challenges and Risks

Side Effects and Overdosage

Bumetanide can cause several side effects, including hyperuricemia, hypochloremia, hypokalemia, and other electrolyte imbalances. Overdosage can lead to acute profound water loss, volume and electrolyte depletion, and circulatory collapse[2].

Regulatory Changes

Changes in regulatory policies can impact the market dynamics of Bumetanide. Compliance with stringent regulations is essential to maintain market presence and ensure the safety and efficacy of the drug[1].

Key Takeaways

• The Bumetanide API market is projected to grow significantly, driven by increasing demand for diuretic therapies.
• North America and Europe are the dominant regions, with the Asia-Pacific region emerging as a significant growth area.
• Continuous R&D investments and expanding indications are key drivers of market growth.
• The competitive landscape is characterized by established players and new entrants competing on various factors.
• Pricing dynamics vary based on dosage and form, with generic options offering cost-effective alternatives.

FAQs

What is the current market size of the Bumetanide API market?

The Bumetanide API market is valued at approximately USD 450 million in 2023[1].

Which region holds the largest share in the Bumetanide API market?

North America holds the largest share in the Bumetanide API market[1].

Who are the leading players in the Bumetanide API market?

Leading players include Teva Pharmaceuticals, Sun Pharmaceutical Industries, and Mylan[1].

What is the growth rate of the Bumetanide API market?

The growth rate of the Bumetanide API market is estimated at a CAGR of 6% from 2024 to 2033[1].

What are the primary factors contributing to the growth of the Bumetanide API market?

The primary factors include the increasing prevalence of cardiovascular diseases, therapeutic versatility, regulatory compliance, R&D investments, and the rising elderly demographic[1].

Sources

1. DataHorizon Research: Bumetanide API Market Size, Growth and Analysis Report - 2033.
2. FDA: Bumex (bumetanide) - accessdata.fda.gov.
3. Drug Patent Watch: Generic BUMETANIDE INN entry.
4. MarketWide Research: Bumetanide Injection Market 2024-2032 | Size, Share, Growth.
5. DrugBank: Bumetanide: Uses, Interactions, Mechanism of Action.