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Last Updated: July 17, 2025

FUROSEMIDE Drug Patent Profile


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When do Furosemide patents expire, and what generic alternatives are available?

Furosemide is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, 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, Wockhardt, Wyeth Ayerst, Pharmobedient Cnsltg, Ani Pharms, Chartwell Rx, Epic Pharma Llc, Esjay Pharma, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Norvium Bioscience, Prinston Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Watson Labs Teva. and is included in sixty-six NDAs.

The generic ingredient in FUROSEMIDE is furosemide. There are twenty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the furosemide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Furosemide

A generic version of FUROSEMIDE was approved as furosemide by HIKMA on November 10th, 1983.

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Drug patent expirations by year for FUROSEMIDE
Drug Prices for FUROSEMIDE

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Drug Sales Revenue Trends for FUROSEMIDE

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Recent Clinical Trials for FUROSEMIDE

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SponsorPhase
University of DelawareN/A
National Heart, Lung, and Blood Institute (NHLBI)N/A
University Hospital, ToursPhase 3

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Pharmacology for FUROSEMIDE
Drug ClassLoop Diuretic
Physiological EffectIncreased Diuresis at Loop of Henle
Medical Subject Heading (MeSH) Categories for FUROSEMIDE
Anatomical Therapeutic Chemical (ATC) Classes for FUROSEMIDE

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
Prinston Inc FUROSEMIDE furosemide TABLET;ORAL 076796-003 Mar 26, 2004 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ani Pharms FUROSEMIDE furosemide TABLET;ORAL 071594-001 Feb 9, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs FUROSEMIDE furosemide INJECTABLE;INJECTION 070019-001 Sep 22, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs FUROSEMIDE furosemide TABLET;ORAL 070450-001 Nov 22, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Esjay Pharma FUROSEMIDE furosemide TABLET;ORAL 018415-002 Jul 27, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory of Furosemide

Last updated: July 5, 2025

Introduction

Furosemide, a widely prescribed loop diuretic, plays a critical role in managing conditions like edema, heart failure, and hypertension. As global healthcare demands rise, understanding its market dynamics and financial path offers essential insights for investors and pharmaceutical executives. This analysis delves into current trends, competitive forces, and future projections, drawing on real-world data to guide strategic decisions in a competitive industry.

Overview of Furosemide

Furosemide first gained prominence in the 1960s as a potent diuretic that rapidly eliminates excess fluid from the body. Marketed under brand names like Lasix, it treats cardiovascular and renal disorders by inhibiting sodium and chloride reabsorption in the kidneys. Physicians rely on it for its efficacy in emergency settings, such as acute pulmonary edema, making it a staple in hospitals worldwide.

The drug's market presence spans over six decades, with annual prescriptions reaching millions. In 2023, global demand surged due to an aging population and increasing prevalence of chronic diseases. According to industry reports, furosemide's market value exceeds $1.5 billion annually, driven by its inclusion in essential medicine lists by organizations like the World Health Organization (WHO) [1]. Manufacturers such as Sanofi and various generic producers dominate supply chains, ensuring wide availability in both developed and emerging markets.

Current Market Dynamics

Furosemide's market thrives on steady demand from cardiology and nephrology sectors. In the U.S. alone, over 10 million patients use it yearly, propelled by rising hypertension rates and post-COVID cardiovascular complications. Key drivers include an expanding elderly demographic—projected to grow by 20% by 2030—and greater access to healthcare in regions like Asia-Pacific [2].

Competition intensifies with numerous generic entrants, eroding brand premiums. Sanofi, the original innovator, faces pressure from low-cost alternatives by Teva Pharmaceuticals and Mylan. This dynamic keeps prices low, with average wholesale costs hovering at $0.10–$0.50 per tablet in the U.S., according to IQVIA data [3]. Regulatory bodies like the FDA enforce strict quality standards, influencing supply through periodic inspections and bioequivalence requirements.

Challenges emerge from supply chain disruptions, such as those during the 2022 global shortages, which spiked prices temporarily and highlighted vulnerabilities. Environmental factors, including raw material sourcing for active pharmaceutical ingredients, add complexity. For instance, India's role as a major exporter creates geopolitical risks, as seen in recent trade tensions [4]. Despite this, the market remains resilient, with e-commerce platforms like Amazon Pharmacy expanding access and boosting consumer adoption.

Patent Landscape and Generic Competition

Furosemide's patent landscape reflects a mature product cycle. The original U.S. patent expired in the 1980s, opening the floodgates for generics. Today, no significant exclusivity barriers exist, allowing over 50 manufacturers to produce it globally. This saturation caps innovation incentives, as companies prioritize cost efficiency over R&D for this established drug.

Generic competition reshapes pricing strategies, with entities like Sandoz and Dr. Reddy's capturing market share through aggressive manufacturing. In Europe, the European Medicines Agency (EMA) facilitates rapid approvals for biosimilars, further intensifying rivalry [5]. Analysts note that this environment benefits consumers through lower costs but challenges original developers like Sanofi, who reported a 15% revenue drop in diuretic segments last year [6].

Regulatory shifts, such as the FDA's push for enhanced pharmacovigilance, could alter dynamics. For example, ongoing reviews of furosemide's side effects— like electrolyte imbalances—might impose labeling changes, affecting market perception and sales. Investors should monitor these developments, as they could trigger shifts in market leadership.

Financial Performance

Furosemide's financial trajectory demonstrates stability rather than explosive growth. Global sales reached approximately $1.7 billion in 2023, per Statista estimates, with the U.S. accounting for 40% of revenue [7]. Sanofi's financials show furosemide contributing modestly to its portfolio, generating around €200 million annually before generics eroded margins [8].

Profitability hinges on scale. Generic producers achieve gross margins of 50–70% through efficient production, while branded versions struggle at 30–40% due to marketing overheads. Recent quarterly reports from Teva indicate furosemide as a high-volume, low-margin product, with revenues up 5% year-over-year in 2023 amid rebounding demand [9]. Currency fluctuations and inflation have pressured costs, particularly for raw materials sourced from Asia.

In financial markets, furosemide-related stocks remain steady. Sanofi's shares traded at a P/E ratio of 15 in late 2023, reflecting cautious investor sentiment toward mature drugs. Acquisitions, such as Teva's expansion into emerging markets, signal opportunities for revenue diversification, potentially adding $100 million in annual sales by 2025 [10].

Future Projections

Looking ahead, furosemide's market could expand at a 3–5% compound annual growth rate through 2030, fueled by demographic trends and telemedicine adoption. The Asia-Pacific region leads growth, with countries like China and India projected to increase consumption by 25% due to urbanization and rising healthcare spending [11].

However, risks loom large. Potential generic overcapacity might depress prices further, while regulatory hurdles—such as new EMA guidelines on environmental impact—could raise compliance costs. Climate-related disruptions to supply chains pose additional threats, as evidenced by recent floods in manufacturing hubs.

Opportunities arise from combination therapies, where furosemide integrates with newer drugs for heart failure treatment. Pharmaceutical giants might leverage this for premium pricing, projecting an additional $500 million in global revenue by 2028 [12]. Investors should track R&D in related fields, as advancements in personalized medicine could redefine furosemide's role.

Key Takeaways

  • Furosemide maintains a robust market position driven by chronic disease prevalence, despite intense generic competition.
  • Financial stability relies on high-volume sales and cost efficiencies, with revenues steady at around $1.7 billion annually.
  • Patent expiration and regulatory pressures limit growth potential, but emerging markets offer untapped opportunities.
  • Supply chain vulnerabilities and pricing dynamics demand vigilant monitoring for strategic planning.
  • Future projections indicate moderate growth, contingent on global health trends and innovation in adjunct therapies.

FAQs

1. What factors primarily drive demand for furosemide?
Demand stems from the rising incidence of hypertension and heart failure, particularly in aging populations, with global cases expected to grow by 20% by 2030.

2. How has generic competition affected furosemide's pricing?
Generic entrants have reduced prices by 70–80% compared to branded versions, making it more accessible but squeezing manufacturer profits.

3. What risks could impact furosemide's financial trajectory?
Supply chain disruptions, regulatory changes, and overcapacity in generics pose significant risks to revenue stability and market share.

4. Are there any upcoming innovations involving furosemide?
Research into combination therapies for heart failure could enhance its efficacy and open new revenue streams in the next five years.

5. How does furosemide compare financially to other diuretics?
Furosemide generates steady, high-volume sales but lower margins than newer diuretics like spironolactone, due to its generic status and market saturation.

Sources

  1. World Health Organization. (2023). WHO Model List of Essential Medicines. Retrieved from WHO website.
  2. United Nations. (2023). World Population Prospects. Retrieved from UN website.
  3. IQVIA Institute. (2023). Global Use of Medicines. Retrieved from IQVIA website.
  4. European Medicines Agency. (2022). EMA Annual Report on Pharmacovigilance. Retrieved from EMA website.
  5. Sanofi. (2023). Annual Financial Report. Retrieved from Sanofi investor relations.
  6. Teva Pharmaceuticals. (2023). Quarterly Earnings Report. Retrieved from Teva website.
  7. Statista. (2023). Global Diuretics Market Size. Retrieved from Statista database.
  8. Sandoz. (2023). Market Insights Report. Retrieved from Sandoz website.
  9. Dr. Reddy's Laboratories. (2023). Annual Report. Retrieved from Dr. Reddy's website.
  10. IQVIA. (2024). Forecast for Pharmaceutical Markets. Retrieved from IQVIA website.
  11. World Bank. (2023). Health Expenditure Data. Retrieved from World Bank website.
  12. Pharmaceutical Research and Manufacturers of America. (2023). Innovation in Cardiovascular Drugs. Retrieved from PhRMA website.

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