FUROSEMIDE - Generic Drug Details

What are the generic sources for furosemide and what is the scope of freedom to operate?

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, Micro Labs, 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-three 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. Sixty suppliers are listed for this compound.

Summary for FUROSEMIDE

International Patents:	24
US Patents:	4
Tradenames:	4
Applicants:	47
NDAs:	73
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	60
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	300
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
Cairo University	NA
BDD Pharma Ltd	PHASE1
SQ Innovation, Inc.	PHASE1

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
Watson Labs	FUROSEMIDE	furosemide	TABLET;ORAL	070412-001	Feb 26, 1986		DISCN	No	No
Sanofi Aventis Us	LASIX	furosemide	SOLUTION;ORAL	017688-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Epic Pharma Llc	FUROSEMIDE	furosemide	TABLET;ORAL	018569-002	Approved Prior to Jan 1, 1982	AB	RX	No	No
Superpharm	FUROSEMIDE	furosemide	TABLET;ORAL	018370-002	Jun 26, 1984		DISCN	No	No
Sun Pharm Inds Inc	FUROSEMIDE	furosemide	TABLET;ORAL	091258-003	Apr 1, 2014		DISCN	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
Sanofi Aventis Us	LASIX	furosemide	SOLUTION;ORAL	017688-001	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
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-002	Approved Prior to Jan 1, 1982	4,324,779

International Patents for FUROSEMIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	367165	FORMULACIONES FARMACÉUTICAS PARA ADMINISTRACIÓN SUBCUTÁNEA DE FUROSEMIDA. (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE.)
South Korea	20210075211	퓨로세마이드의 피하 투여용 약학 제형 (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)
European Patent Office	2981258	FORMULATIONS PHARMACEUTIQUES POUR L'ADMINISTRATION SOUS-CUTANÉE DE FUROSÉMIDE (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)
Mexico	2015014064	FORMULACIONES FARMACEUTICAS PARA ADMINISTRACION SUBCUTANEA DE FUROSEMIDA. (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE.)
European Patent Office	3799869	FORMULATIONS PHARMACEUTIQUES POUR L'ADMINISTRATION SOUS-CUTANÉE DE FUROSÉMIDE (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)

Market Dynamics and Financial Trajectory for FUROSEMIDE

Last updated: March 10, 2026

What are the current market size and growth trends for FUROSEMIDE?

Furosemide, a loop diuretic used primarily for edema, heart failure, and hypertension, generated approximately $600 million globally in 2022. The compound's market size has expanded at a compound annual growth rate (CAGR) of 2.5% from 2018 to 2022. Market growth is driven by increasing prevalence of cardiovascular diseases, particularly in aging populations.

Projected Market Growth:	Year	Estimated Revenue (USD millions)	CAGR (2018-2027)	Notes
2023	$620	2.5%	Post-pandemic recovery
2024	$635	2.4%	Rising chronic disease burden
2025	$650	2.3%	Increased healthcare access
2026	$665	2.2%	Demographic shifts
2027	$680	2.1%	Market stabilization

Asia-Pacific region accounts for approximately 35% of sales, with expanding healthcare investment supporting growth. U.S. and Europe collectively represent 60%, driven by ongoing demand in hospital and outpatient segments.

What are the key factors influencing FUROSEMIDE's market?

1. Prevalence of Cardiovascular and Renal Diseases

Rising incidences of heart failure, hypertension, and renal impairments augment demand. In 2022, the global prevalence of hypertension was approximately 1.28 billion, with many patients requiring diuretic therapy.

2. Patent and Regulatory Status

Furosemide is off-patent since the early 2000s, allowing generic manufacturers to dominate the market. Generic sales constitute over 90% of global revenue, making price competition a significant factor.

3. Competitive Landscape

Major producers include Teva, Sandoz, and Hikma Pharmaceuticals. While branded formulations have declined, bioequivalent generics maintain steady sales. Pricing pressure is high, with average prices declining by 15% year-over-year in certain regions.

4. Supply Chain and Manufacturing

Furosemide production relies on chemical synthesis processes that can be affected by raw material prices and regulatory standards. Supply disruptions have been reported during pandemic peaks, impacting availability.

5. Emerging Market Dynamics

In lower-income countries, increased health awareness and healthcare infrastructure improve access. This expands the patient base, although price sensitivity limits revenue growth per unit.

What are the key financial metrics for FUROSEMIDE?

1. Pricing Trends

Average wholesale prices (AWP) for 40 mg tablets have decreased from $0.10 per tablet in 2018 to $0.085 in 2022 (~15% decline). Volume growth compensates partially for price erosion.

2. Revenue Breakdown

Region	2022 Revenue (USD millions)	Market Share	Growth Drivers
North America	$200	33%	Hospital use, aging demographics
Europe	$180	30%	Chronic disease prevalence
Asia-Pacific	$120	20%	Increasing healthcare access
Rest of World	$100	17%	Emerging markets

3. Profitability and Cost Structure

Generic manufacturing margins are approximately 30%, with R&D expenses minimal due to off-patent status. Marketing costs are primarily related to compliance and supply chain management.

What is the outlook for future market and financial performance?

The forecast indicates slow, steady growth owing to demographic trends and high prevalence of targeting conditions. Market penetration in emerging regions may accelerate growth marginally. However, intensifying price competition and supply chain challenges could suppress margins.

Anticipated trends over next five years:

• Slight decline in average prices due to generic competition.
• Volume increases driven by expanding global healthcare access.
• Potential for biosimilar or alternative diuretic formulations to influence market share.

Key Market Drivers and Risks

Drivers	Risks
Growing aging populations	Price erosion from generic competition
Increasing chronic disease burden	Supply chain disruptions
Healthcare policy reforms favoring cost-effective therapies	Regulatory hurdles in emerging markets

Key Takeaways

Furosemide's market remains mature with modest growth prospects. The primary growth engine is the expanding global burden of cardiovascular and renal diseases. Generics dominate sales, causing downward pressure on prices. Supply chain stability and regional healthcare infrastructure development are critical for sustained revenues.

FAQs

1. How does patent expiration impact FUROSEMIDE sales?
Patent expiration in the early 2000s led to a surge in generic competition, reducing the market price and margins but increasing volume sales.

2. What regional factors influence FUROSEMIDE's market?
High disease prevalence in North America and Europe sustains steady demand. Emerging markets in Asia-Pacific and Africa increase accessibility but are constrained by pricing sensitivity.

3. How do supply chain issues affect FUROSEMIDE?
Disruptions in raw material sourcing and manufacturing can reduce availability, impacting sales and pricing.

4. Are there new formulations or alternatives threatening FUROSEMIDE?
While diuretics like torsemide (another loop diuretic) exist, FUROSEMIDE maintains dominance due to extensive clinical history and proven efficacy.

5. What is the future outlook for profitability in FUROSEMIDE?
Margins are likely to decline marginally due to competitive pricing, but volume growth in emerging markets offers compensation.

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References

1. MarketWatch. (2023). Global Furosemide Market Analysis.
2. World Health Organization. (2022). Global Status Report on Cardiovascular Diseases.
3. IQVIA. (2022). Global Generic Drug Market Review.
4. Scrip. (2022). Diuretic Market Trends and Outlook.
5. U.S. Food and Drug Administration. (2022). Drug Approvals and Market Data.