BUMETANIDE - Generic Drug Details

What are the generic 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, Lupin Ltd, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Validus Pharms, Amneal Pharms Co, Appco, Heritage Pharma, Rising, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for BUMETANIDE

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	19
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	29
Patent Applications:	6,695
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

See drug sales revenues for BUMETANIDE

Recent Clinical Trials for BUMETANIDE

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

Sponsor	Phase
Mayo Clinic	Phase 2
Yale University	Phase 1
Vrije Universiteit Brussel	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Appco	BUMETANIDE	bumetanide	TABLET;ORAL	212931-002	Sep 18, 2024	AB	RX	No	No
Appco	BUMETANIDE	bumetanide	TABLET;ORAL	212931-001	Sep 18, 2024	AB	RX	No	No
Lupin Ltd	BUMETANIDE	bumetanide	INJECTABLE;INJECTION	217153-001	Sep 17, 2024	AP	RX	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	018225-001	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

BUMETANIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bumetanide

Introduction

Bumetanide, a loop diuretic, is widely used in managing various edematous conditions, including those secondary to cardiac failure, hepatic or renal disease, and nephrotic syndrome. Understanding the market dynamics and financial trajectory of bumetanide is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global market for bumetanide tablets is anticipated to experience significant growth. As of 2023, the market had reached a substantial value, and it is projected to continue growing, reaching a higher value by 2031[1].

Key Indications and Usage

Bumetanide is FDA-approved for managing edema associated with cardiac failure, hepatic or renal disease, and nephrotic syndrome. It is also used off-label for treating hypertension, acute hypercalcemia, and in some cases, seizures and behavioral problems in patients with conditions like tuberous sclerosis[3].

Competitive Landscape

Bumetanide competes in the loop diuretic market alongside other prominent drugs such as furosemide and torsemide. However, bumetanide and torsemide have better bioavailability compared to furosemide, which can influence market share and patient preference[5].

Production Costs and Supply Chain

The production costs and supply chain dynamics play a critical role in the market analytics of bumetanide tablets. Factors such as raw material costs, manufacturing processes, and distribution networks can impact the overall cost and availability of the drug[4].

Pharmaceutical Market Trends

The pharmaceutical market for diuretics, particularly loop diuretics, is driven by the increasing prevalence of cardiovascular and renal diseases. Early administration of loop diuretics like bumetanide in acute decompensated heart failure is linked to lower in-hospital mortality rates, which can drive demand and market growth[5].

Bioavailability and Administration

Bumetanide's high bioavailability, whether administered orally or intravenously, is a significant market advantage. It has equivalent bioavailability in both oral and IV forms, making it a preferred option for patients who cannot take oral medications[3].

Dosing and Pricing Strategies

The dosing regimens for bumetanide vary based on the condition being treated. For edema, the typical dosage ranges from 0.5 to 10 mg per day, divided into one or two doses. Pricing strategies often consider the cost-effectiveness of bumetanide compared to other loop diuretics and the potential for long-term cost savings through better patient outcomes[3].

Regulatory Environment

Bumetanide's FDA approval for specific indications and its off-label uses are crucial for its market positioning. Regulatory changes or new approvals can significantly impact the financial trajectory of the drug[3].

Clinical Outcomes and Market Impact

Recent studies highlighting the positive effects of bumetanide on cognitive functioning in patients with refractory epilepsy and its role in reducing seizure frequency can expand its market potential beyond traditional indications[2].

Global Expansion Strategies

To surge ahead in the global market, pharmaceutical companies may focus on expanding distribution networks, especially in regions with high prevalence of cardiovascular and renal diseases. Strategic partnerships and local manufacturing can also enhance market penetration[4].

Financial Projections

Given the projected growth in the global market, the financial trajectory for bumetanide is expected to be positive. Increased demand driven by clinical efficacy, better bioavailability, and strategic marketing could lead to significant revenue growth over the next few years[1].

Challenges and Opportunities

Despite the positive outlook, there are challenges such as competition from other diuretics, potential side effects, and the need for continuous monitoring of patients. However, opportunities exist in expanding into new therapeutic areas, such as neurocognitive disorders, and improving patient outcomes through combination therapies[2][3].

Interprofessional Team Strategies

Effective management of bumetanide therapy requires an interprofessional team approach, including clinicians, nurses, and pharmacists. This coordinated care can enhance patient outcomes, reduce readmissions, and ultimately impact the financial performance of the drug in the market[3].

Key Takeaways

• Market Growth: The global bumetanide market is projected to grow significantly by 2031.
• Competitive Advantage: Bumetanide's high bioavailability and efficacy in various indications position it favorably against competitors.
• Clinical Outcomes: Positive clinical outcomes, especially in reducing seizure frequency and improving cognitive functions, can expand market potential.
• Global Expansion: Strategic expansion into new regions and therapeutic areas can drive revenue growth.
• Regulatory Environment: FDA approvals and off-label uses are critical for market positioning.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for bumetanide? A: Bumetanide is primarily used to manage edema associated with cardiac failure, hepatic or renal disease, and nephrotic syndrome[3].

Q: How does bumetanide compare to other loop diuretics in terms of bioavailability? A: Bumetanide has better bioavailability compared to furosemide and is equivalent in both oral and IV forms[3][5].

Q: What are the potential off-label uses of bumetanide? A: Bumetanide may be used off-label for treating hypertension, acute hypercalcemia, and in some cases, seizures and behavioral problems in patients with conditions like tuberous sclerosis[3].

Q: How does bumetanide impact cognitive functioning in patients with epilepsy? A: Bumetanide has shown positive effects on cognitive functioning through microstructural changes in the brain, reducing seizure frequency and improving cognitive operations such as selective attention and processing speed[2].

Q: What are the key factors influencing the financial trajectory of bumetanide? A: Factors include market growth, competitive advantage, clinical outcomes, global expansion strategies, and the regulatory environment[1][3][4].

Cited Sources:

1. Market Research Intellect: Bumetanide Tablets Sales Market Size, Scope And Forecast Report.
2. Frontiers in Neurology: Longitudinal Effects of Bumetanide on Neuro-Cognitive Functioning.
3. NCBI Bookshelf: Bumetanide - StatPearls.
4. News Channel Nebraska: Bumetanide Tablets Market Analytics Surge and Global Expansion Strategies.
5. The Cleveland Clinic Journal of Medicine: How do we maximize diuresis in acute decompensated heart failure?