LASIX Drug Patent Profile

Which patents cover Lasix, and when can generic versions of Lasix launch?

Lasix is a drug marketed by Sanofi Aventis Us, Validus Pharms, and Sq Innovation. and is included in four NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lasix

A generic version of LASIX was approved as furosemide by ESJAY PHARMA on July 27^th, 1982.

Summary for LASIX

US Patents:	0
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	108
Patent Applications:	3,014
Drug Prices:	Drug price information for LASIX
What excipients (inactive ingredients) are in LASIX?	LASIX excipients list
DailyMed Link:	LASIX at DailyMed

See drug prices for LASIX

See drug sales revenues for LASIX

Pharmacology for LASIX

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

US Patents and Regulatory Information for LASIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	LASIX	furosemide	INJECTABLE;INJECTION	016363-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Sanofi Aventis Us	LASIX	furosemide	SOLUTION;ORAL	017688-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for LASIX

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	016273-001	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	016273-002	Approved Prior to Jan 1, 1982	4,324,779

International Patents for LASIX

See the table below for patents covering LASIX around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2343218
South Africa	7405443
Austria	A694274
Denmark	455274

Market Dynamics and Financial Trajectory for LASIX (Furosemide)

Last updated: August 3, 2025

Introduction

LASIX, the brand name for furosemide, is a widely prescribed loop diuretic primarily used to manage edematous conditions associated with congestive heart failure, liver cirrhosis, and renal disease, as well as hypertension. Since its discovery in the 1960s and subsequent FDA approval, LASIX has become a cornerstone in the treatment of fluid overload syndromes. This article explores the evolving market landscape, key drivers, competitive forces, and financial prospects shaping LASIX's trajectory in the pharmaceutical domain.

Historical Context and Market Significance

Furosemide’s patent expiration in the early 2000s catalyzed the proliferation of generic versions, significantly reducing costs and expanding accessibility. Despite the advent of alternative diuretics and novel antihypertensives, LASIX maintains a substantial market share due to its efficacy, affordability, and extensive clinical use. The global demand for diuretics, inclusive of LASIX, underscores a consistent need linked to aging populations and increasing prevalence of cardiovascular and renal disorders.

Market Dynamics

1. Demographic and Epidemiological Drivers

Global demographic shifts markedly influence LASIX’s demand. The World Health Organization reports a rising prevalence of hypertension, congestive heart failure, and chronic kidney disease, especially among aging populations in North America, Europe, and parts of Asia. The aging demographic typically exhibits increased burden of volume overload conditions, reinforcing LASIX's role as a first-line therapy.

Moreover, rising lifestyle-related risk factors, such as obesity and diabetes, escalate incident rates of target conditions, indirectly expanding LASIX’s therapeutic market. According to a report by Grand View Research, the global diuretic drugs market is projected to grow at a CAGR of approximately 3.8% through 2030[1].

2. Competitive Landscape and Market Share

Post-patent expiration, generic manufacturers dominate the LASIX market. Major pharmaceutical companies such as Teva, Sandoz, and Mylan produce cost-effective versions, intensifying price competition. While innovative therapies for hypertension and edema are emerging, LASIX’s simplicity, low cost, and long-standing clinical track record sustain its usage.

Biopharmaceutical advancements are focused on developing diuretic combinations and novel molecules with improved safety profiles, potentially impacting LASIX’s market dominance. Nonetheless, generic proliferation limits pricing power for branded LASIX, though its high volume ensures stable revenue streams for manufacturers.

3. Regulatory and Pricing Environment

Regulatory frameworks, particularly in the U.S. and Europe, facilitate ongoing market access for LASIX. Payers and healthcare systems favor cost-effective treatments, bolstering the role of generics. However, price pressures and reimbursement policies are under scrutiny, with governments seeking to cap drug prices. This dynamic constrains revenue growth but sustains volumetric sales.

4. Supply Chain and Manufacturing Factors

LASIX’s production relies on established manufacturing processes with broad patent expiration. Any disruptions—such as supply chain bottlenecks in active pharmaceutical ingredients (APIs)—could influence availability and pricing. Increased focus on manufacturing resilience post-pandemic prompts strategic inventory management among suppliers.

Financial Trajectory

1. Revenue Trends

Global LASIX sales are substantial, with estimates suggesting hundreds of millions of dollars annually. The U.S. remains the largest market, given its extensive healthcare infrastructure and high prevalence of target conditions. The flattening of growth in mature markets is counterbalanced by expanding demand in emerging markets like India and Southeast Asia.

2. Impact of Patent Expiry and Generics

Patent expiration catalyzed commoditization, leading to significant price erosion. However, high sales volume mitigates revenue declines for manufacturing firms. Companies that diversified their portfolio or innovated in related diuretic classes tend to offset generic market pressures.

3. Future Growth Projections

While the core demand for LASIX as a generic diuretic is steady, growth prospects hinge upon several factors:

• Aging Population: Continued demographic trends support sustained demand.
• Regulatory Environment: Favorable policies promote access, but price controls could suppress margins.
• Advancements in Diuretic Therapy: Emergence of combination therapies or new molecules may limit LASIX’s market share.
• Geographic Expansion: Increasing healthcare access in emerging markets opens new revenue channels.

Industry estimates project a compound annual growth rate (CAGR) of approximately 2-4% for LASIX-related sales over the next decade, primarily driven by volume expansion rather than price increases[1].

4. Cost Dynamics

The manufacturing cost structure is relatively stable due to existing infrastructure. However, increased procurement costs of APIs and regulatory compliance can pressure margins. Companies investing in supply chain optimization and cost-effective production methodologies stand to sustain profitability.

5. Strategic Considerations

To maintain financial stability, stakeholders must adapt to evolving competitive and regulatory environments via:

• Developing combination therapies incorporating LASIX.
• Investing in formulations with improved patient adherence.
• Expanding into untapped markets with high disease burden.
• Leveraging digital health tools to improve treatment management.

Conclusion and Outlook

LASIX's market remains resilient amidst challenges of generic competition and evolving treatment paradigms. Its proven efficacy, affordability, and extensive clinical backing secure a foundational role in managing fluid overload conditions. The future financial trajectory for LASIX hinges on demographic trends, regulatory policies, and competitive innovations. Companies that strategically navigate these factors, emphasizing cost efficiencies and market expansion, will sustain stable revenue streams.

Key Takeaways

• The global demand for LASIX remains robust, primarily driven by aging populations and increased incidence of cardiovascular and renal conditions.
• Patent expiration precipitated a shift towards generics, constraining pricing but maintaining high sales volumes.
• Emerging markets represent significant growth opportunities due to expanding healthcare infrastructure.
• Competitive pressures necessitate innovation in formulation, combination therapy, and digital health integration.
• Regulatory and pricing environments will continue to influence profitability; strategic diversification and cost management are critical for sustained success.

FAQs

1. How does LASIX remain relevant despite the availability of newer diuretics?
LASIX's proven efficacy, low cost, widespread clinical familiarity, and extensive legacy data sustain its relevance. It remains a first-line option, especially in resource-limited settings, while newer agents often target specific patient populations or aim to reduce side effects.

2. What factors could threaten LASIX’s market position?
Emerging diuretics with improved safety profiles, strategic patenting of innovative formulations, or shifting clinical guidelines favoring alternative therapies could impact LASIX’s dominance.

3. Are there ongoing innovations related to LASIX?
While substantial innovation is limited due to patent expiry and generic competition, efforts focus on combination therapies, sustained-release formulations, and adjunct digital health tools to improve adherence.

4. How do regulatory policies impact LASIX sales across different regions?
Regulatory agencies encourage cost-effective treatments, favoring generics, which benefits LASIX. Conversely, strict price controls or reimbursement caps may limit revenue growth despite stable demand.

5. What strategies can manufacturers adopt to maximize LASIX’s market potential?
Manufacturers should explore geographic expansion, product differentiation through formulations, strategic partnerships for combination drugs, and leveraging digital health innovations to enhance adherence and outcomes.

Sources

[1] Grand View Research, "Diuretic Drugs Market Size, Share & Trends Analysis," 2022.