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-five 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:	25
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
SQ Innovation, Inc.	PHASE1
BDD Pharma Ltd	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
Chartwell Rx	FUROSEMIDE	furosemide	TABLET;ORAL	018413-001	Nov 30, 1983		DISCN	No	No
Accord Hlthcare	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	070017-001	Dec 15, 1986	AP	RX	No	No
Ani Pharms	FUROSEMIDE	furosemide	TABLET;ORAL	071594-001	Feb 9, 1988		DISCN	No	No

Expired US Patents for FUROSEMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-002	Approved Prior to Jan 1, 1982	4,324,779
Sanofi Aventis Us	LASIX	furosemide	INJECTABLE;INJECTION	016363-001	Approved Prior to Jan 1, 1982	4,324,779
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-001	Approved Prior to Jan 1, 1982	4,324,779

International Patents for FUROSEMIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3799869	FORMULATIONS PHARMACEUTIQUES POUR L'ADMINISTRATION SOUS-CUTANÉE DE FUROSÉMIDE (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)
Brazil	112015025204
Canada	2908935

Market Dynamics and Financial Trajectory for FUROSEMIDE

Last updated: April 10, 2026

What defines the current market landscape for FUROSEMIDE?

Furosemide, a loop diuretic primarily used to treat edema associated with congestive heart failure, liver cirrhosis, and renal disease, faces a complex market environment influenced by patent status, generics, and regulatory developments. The drug has been on the market since the 1960s, with high global consumption driven by chronic conditions requiring fluid management.

How does patent status and generic competition influence FUROSEMIDE's market?

The original patents for FUROSEMIDE expired decades ago. Consequently, the market is dominated by multiple generic manufacturers in over 100 countries. This widespread generic availability results in low per-unit prices. For example, retail prices for a 40mg tablet range from $0.10 to $0.20, with significant regional variations.

Generic competition reduces profit margins for branded formulations. The global market for diuretics, including FUROSEMIDE, was valued at approximately $1.8 billion in 2022, with FUROSEMIDE accounting for roughly 65% of that figure[1].

What are key factors affecting supply and demand?

Supply stability is high due to multiple manufacturers and established manufacturing processes. Demand remains robust in treating volume conditions, but trends shift due to evolving treatment guidelines emphasizing newer therapies for heart failure. The rise of alternative diuretics, such as torsemide and bumetanide, impacts FUROSEMIDE’s market share.

In regions where healthcare budgets tighten, the drug’s low cost supports continued usage, particularly in low-income countries. However, in high-income regions, clinicians increasingly adopt newer drugs supported by recent clinical data, potentially reducing FUROSEMIDE’s share.

How do regulatory and reimbursement policies affect market access?

Regulatory agencies, including the FDA and EMA, have no recent patent restrictions, facilitating generic entry. Reimbursement policies favor low-cost treatments for chronic conditions. In the US, government programs like Medicaid and Medicare heavily influence prescribing behaviors, supporting widespread FUROSEMIDE use.

In some regions, regulatory hurdles or formulary restrictions favor newer pharmaceuticals with patent protection, marginally constraining FUROSEMIDE’s growth.

What is the financial outlook for FUROSEMIDE?

Given the mature patent landscape, industry revenue is primarily composed of generics sales. The global trade volume exceeds 2 billion tablets annually[2]. Price erosion continues, with average prices declining at approximately 2-4% annually over the past five years.

Forecasts indicate a compound annual growth rate (CAGR) of approximately -1% for FUROSEMIDE sales globally over the next five years, driven by:

• Increased adoption of alternative diuretics with potentially improved efficacy.

• Regulatory pressures favoring newer agents.

• Price competition among generic manufacturers.

However, in emerging markets where cost constraints predominate, demand could stabilize or slightly increase, offsetting declines elsewhere.

How are manufacturing and distribution strategies influencing revenue?

Manufacturers focus on cost efficiency and maintaining multiple production sites to mitigate supply risks. Distribution channels are increasingly digital, improving access in remote areas. Some producers explore biosimilar formulations and fixed-dose combinations to extend market share, though these strategies are limited given FUROSEMIDE’s simple chemical structure.

What are the risks to FUROSEMIDE’s market and financial trajectory?

Key risks include:

• Pricing and reimbursement reforms reducing profitability.

• Competitive displacement by newer diuretics or combination products.

• Regulatory developments demanding new efficacy or safety data.

• Supply chain disruptions impacting availability in key markets.

Summary table: Market Indicators for FUROSEMIDE

Indicator	Data	Implication
Estimated global sales (2022)	$1.17 billion (approximate, 65% of diuretics market)	Mature, commoditized market
Price trend (2018-2022)	Declined 2-4% annually	Ongoing price erosion
Number of manufacturers	Over 30 globally	High competition, limited profit margins
Demand growth rate	Approximately -1% CAGR (2023-2028)	Market contraction expected in developed regions
Alternative diuretics	Torsemide, bumetanide gaining favor in some markets	Market share shift away from FUROSEMIDE

Key takeaways

• The FUROSEMIDE market is highly commoditized with multiple generic manufacturers, leading to low prices and slim margins.
• Demand remains stable in low-income regions but declines in high-income zones due to competition and newer drugs.
• Price erosion and regulatory shifts forecast a slight decline in global sales over the next five years.
• Emerging markets may preserve or increase demand due to cost sensitivity.
• Manufacturers focus on operational efficiencies, product differentiation through fixed-dose combinations, and supply chain resilience.

FAQs

1. How sustainable is FUROSEMIDE’s market position?
Market sustainability depends on continued demand in low-income regions and the decline in high-income areas due to competition and newer agents. As a mature product with expired patents, its market will mainly be driven by cost-sensitive healthcare systems.

2. Are there any regulatory threats to FUROSEMIDE?
No current patent protections exist. Regulatory agencies prioritize safety and efficacy data; however, existing approvals are longstanding, limiting threat from regulatory changes.

3. What role do emerging markets play in FUROSEMIDE's outlook?
Emerging markets contribute significantly due to affordability and widespread use. Demand could grow or stabilize if local healthcare budgets sustain low-cost treatment options.

4. Can innovation extend FUROSEMIDE’s market life?
Limited. The drug’s chemical simplicity restricts innovation. Most efforts focus on formulation improvements or fixed-dose combinations rather than pharmaceutical innovation.

5. Will price regulation impact FUROSEMIDE’s profitability?
Yes. Price controls in certain countries could further diminish revenue, especially in regions with government-mandated price caps.

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References

[1] IBISWorld. (2023). Diuretics Market Reports. Retrieved from https://www.ibisworld.com

[2] Global Data. (2022). Diuretics Volume and Value Analytics. Retrieved from https://www.globaldata.com