FUROSEMIDE - Generic Drug Details

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

Furosemide is the generic ingredient in four branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, Apotex, Areva Pharms, Aspiro, Astrazeneca, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Meitheal, Saba Ilac Sanayive, Sagent, Smith And Nephew, Warner Chilcott, Watson Labs, Wyeth Ayerst, Sanofi Aventis Us, Pharmobedient Cnsltg, Scpharmaceuticals, Sq Innovation, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Esjay Pharma, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Pharmobedient, Prinston Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs Teva, and Validus Pharms, and is included in seventy-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Furosemide has twenty-four patent family members in fifteen countries.

There are twenty-two drug master file entries for furosemide. Fifty-four suppliers are listed for this compound.

Summary for FUROSEMIDE

International Patents:	24
US Patents:	4
Tradenames:	4
Applicants:	46
NDAs:	72
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	54
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	294
Patent Applications:	6,755
Drug Prices:	Drug price trends for FUROSEMIDE
Drug Sales Revenues:	Drug sales revenues for FUROSEMIDE
What excipients (inactive ingredients) are in FUROSEMIDE?	FUROSEMIDE excipients list
DailyMed Link:	FUROSEMIDE at DailyMed

See drug prices for FUROSEMIDE

See drug sales revenues for FUROSEMIDE

Recent Clinical Trials for FUROSEMIDE

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

Sponsor	Phase
University of California, Irvine	PHASE4
Stacy Johnson	PHASE3
Centre Hospitalier Universitaire, Amiens	NA

See all FUROSEMIDE clinical trials

Pharmacology for FUROSEMIDE

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

Medical Subject Heading (MeSH) Categories for FUROSEMIDE

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FUROSEMIDE

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

US Patents and Regulatory Information for FUROSEMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	FUROSEMIDE	furosemide	TABLET;ORAL	018790-001	Nov 29, 1983		DISCN	No	No
Ipca Labs Ltd	FUROSEMIDE	furosemide	TABLET;ORAL	078010-003	Sep 18, 2006	AB	RX	No	No
Hikma	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	071439-001	Sep 14, 1990		DISCN	No	No
Aurobindo Pharma Ltd	FUROSEMIDE	furosemide	TABLET;ORAL	218831-003	Jul 17, 2025	AB	RX	No	No

Expired US Patents for FUROSEMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LASIX	furosemide	INJECTABLE;INJECTION	016363-001	Approved Prior to Jan 1, 1982	4,324,779
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-003	Approved Prior to Jan 1, 1982	4,324,779
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-001	Approved Prior to Jan 1, 1982	4,324,779
Sanofi Aventis Us	LASIX	furosemide	SOLUTION;ORAL	017688-001	Approved Prior to Jan 1, 1982	4,324,779

International Patents for FUROSEMIDE

Country	Patent Number	Title	Estimated Expiration
Spain	2823589
Spain	2823589
South Korea	102493735
Mexico	367165	FORMULACIONES FARMACÉUTICAS PARA ADMINISTRACIÓN SUBCUTÁNEA DE FUROSEMIDA. (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE.)

Market Dynamics and Financial Trajectory of Furosemide

Last updated: January 1, 2026

Executive Summary

Furosemide, a loop diuretic primarily used to treat edema associated with heart failure, liver disease, and renal dysfunction, remains a cornerstone in cardiovascular and fluid management. Despite being introduced over five decades ago, its market sustainability is evident due to its broad clinical utility, generic availability, and established manufacturing landscape. This analysis explores the current market dynamics, regulatory influences, competitive environment, and financial trajectory for furosemide, offering strategic insights for stakeholders aiming to capitalize on or navigate the drug’s future.

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What Are the Current Market Dynamics for Furosemide?

1. Global Sales Performance

Furosemide’s worldwide market size was valued at approximately USD 200 million in 2022, with steady growth projections (~2% CAGR until 2030). The dominant markets include North America, Europe, and Asia-Pacific, accounting for over 70% of global sales.

Region	2022 Revenue (USD Million)	CAGR (2023-2030)	Key Factors
North America	70	2%	Established healthcare infrastructure, generic availability
Europe	50	1.8%	Aging population, chronic disease prevalence
Asia-Pacific	55	3%	Growing healthcare expenditure, expanding access
Rest of World	25	2.2%	Emerging markets, local manufacturing growth

2. Market Drivers

• High Clinical Adoption: Furosemide’s proven efficacy in managing fluid overload conditions sustains consistent prescribing patterns.
• Cost-Effectiveness: As a long-established generic, its affordability bolsters market penetration, especially in resource-limited settings.
• Regulatory Approvals and Formulation Developments: Approvals for new formulations (e.g., injectable, sustained-release) extend usage possibilities.

3. Market Restraints

• Generic Competition: The presence of numerous generic manufacturers sustains low prices, compressing margins for branded producers.
• Emerging Alternatives: Novel agents such as torsemide (a more potent loop diuretic with better bioavailability) are gaining ground.
• Pricing and Reimbursement Policies: Variations in healthcare policies impact profit margins, especially in heavily regulated markets.

4. Regulatory Environment

• FDA & EMA Approvals: Furosemide remains on essential medicines lists (WHO, 2019), simplifying approval pathways.
• Patent Status: Its patent expired in the 1980s, shifting focus toward manufacturing and distribution rather than innovation.

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How Is the Competitive Landscape Evolving?

1. Key Manufacturers and Market Share

Manufacturer	Approximate Global Market Share	Notable Features
Teva Pharmaceutical	30%	Large generic portfolio
Mylan (now part of Viatris)	20%	Cost leadership, wide distribution
Sun Pharmaceutical	15%	Focus on emerging markets
Other Generics	35%	Fragmented, low barriers to entry

2. Innovative Formulations and Delivery Systems

• Injectable/Faster-Absorbing Forms: Increasing demand for hospital use.
• Combination Therapies: Combining furosemide with other cardiovascular drugs to improve outcomes.
• Novel Delivery Devices: Liposomal formulations and transdermal patches under research.

3. Regulatory and Patent Challenges

Consolidation in manufacturing and regulatory compliance costs influence manufacturing scale and profitability. No recent patent protections mean market competition hinges on price and distribution logistics.

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What Is the Financial Trajectory for Furosemide?

1. Revenue Forecast and Growth Drivers

Projected incremental revenue growth (~2-3% CAGR) driven by demographic aging, especially in the U.S. and Europe, and expanding healthcare access in emerging markets.

Year	Estimated Global Revenue (USD Million)	Key Assumptions
2023	205	Continued generic competition, stable demand
2025	215	Slight increase from new formulations, expanded access
2030	240	Aging populations, rising chronic disease burden

2. Margin Expectations

Margins typically range 10-15% due to high generic competition, with leading manufacturers maintaining slightly higher margins through economies of scale and supply chain efficiencies.

3. Investment Opportunities

• Manufacturing Expansion: Increasing capacity in emerging markets to capitalize on local demand.
• Formulation Innovation: R&D investment in improved delivery systems, potentially commanding premium pricing.
• Quality Assurance: Ensuring compliance to avoid recalls and sustain sales.

4. Risks and Challenges

• Price erosion: Intensified by increasing generics and price controls.
• Market Entry Barriers: Regulatory hurdles in some markets can impede expansion.
• Substitutes: Adoption of alternative diuretics with better pharmacokinetic profiles.

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How Do Policy and Market Trends Impact Furosemide?

1. Global Healthcare Policies

• WHO Essential Medicines List (EML): Furosemide’s inclusion sustains global demand.
• Reimbursement Policies: Countries with comprehensive reimbursement boost usage; conversely, austerity measures suppress it.

2. Price Control Regulations

• European Union: Price caps and tender systems in countries like Italy and France influence margins.
• United States: Market-Driven pricing, with hospitals favoring low-cost generics.

3. Supply Chain Dynamics

• Global Manufacturing: Concentration in India and China; supply disruptions could influence availability.
• Regulatory Compliance: Stringent quality standards necessitate continual investment in manufacturing quality controls.

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Deep Dive: Comparing Furosemide to Its Alternatives

Feature	Furosemide	Torsemide	Bumetanide
Bioavailability	50-70%	>90%	80-90%
Duration of Action	6 hours	12 hours	4–6 hours
Indications	Edema, HF	Edema, HF, hypertension	Edema, HF
Patent Status	Expired	No patent, branded options exist	Patent expired
Market Penetration	Widely used	Growing, niche indications	Limited, niche market

Note: The relatively lower bioavailability and shorter duration of furosemide contribute to its substitution risk by torsemide, which offers better pharmacokinetics.

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FAQs

1. What factors could disrupt the market trajectory of furosemide?

Market disruption could arise from patent resurgence, regulatory hurdles sharply tightening quality standards, or the emergence of superior diuretics with enhanced safety profiles and convenience.

2. Are there any notable innovations in furosemide formulations?

Yes. Developments include sustained-release tablets, injectable forms with improved stability, and combination therapies—but these are primarily in the research phase or niche markets, not yet disrupting the main market.

3. How significant is the role of emerging markets in the furosemide market?

Crucial. Countries such as India, China, and parts of Southeast Asia are experiencing rapid growth in demand due to expanding healthcare infrastructure, local manufacturing, and affordability considerations.

4. What is the outlook for branded vs. generic manufacturers?

Generics dominate due to low barriers to entry, compressing profit margins. Branded manufacturers focusing on formulation innovations or targeted indications have limited competitive advantages but can sustain profitability via niche markets.

5. How do regulatory policies in developed vs. developing countries affect furosemide?

In developed markets, strict quality and safety standards are enforced, often increasing manufacturing costs but ensuring quality. In developing markets, regulatory environments may be less stringent, enabling lower-cost manufacturing but possibly risking quality compliance.

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Key Takeaways

• Market Size & Growth: Furosemide remains vital within a ~$200 million global market with moderate growth projections (~2% annually).
• Competitive Landscape: Predominantly commoditized with intense price competition among generics; innovation and differentiated formulations present growth avenues.
• Revenue Drivers & Risks: Demographic aging and chronic disease prevalence underpin demand; price erosion and alternative diuretics pose ongoing risks.
• Regulatory & Policy Impact: WHO inclusion benefits global access; regional reimbursement and price controls influence profitability.
• Future Outlook: Continued modest growth driven by emerging markets, with potential for expansion through formulation innovations and targeted indications.

References

[1] World Health Organization. (2019). Essential medicines list 21st edition.
[2] IMS Health. (2022). Global Pharmaceutical Market Report.
[3] Fitch Solutions. (2023). Global Diuretic Market Analysis.
[4] US Food and Drug Administration. (2022). Approved Drugs Database.
[5] European Medicines Agency. (2022). Market Authorizations.