LASIX Drug Patent Profile

Which patents cover Lasix, and what generic alternatives are available?

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. Sixty 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

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		DISCN	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		DISCN	Yes	No

International Patents for LASIX

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

Country	Patent Number	Title	Estimated Expiration
Egypt	14662	PROCESS FOR THE MANUFACTURE OF NOVEL PREPARATION CONTAINING N-(2-FURFURYL)-4-CHLORO-5-SULFAMOYL-ANTHRANILIC ACID
Denmark	455274
Netherlands	7411269
Denmark	155173

LASIX Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Investment Outlook for LASIX?

Lasix (furosemide) remains a prominent diuretic in the treatment of edema and hypertension. Current investment potential depends on patent status, market demand, generic competition, and regulatory trends.

How Does Patent and Market Dynamics Influence LASIX Investment?

Lasix's patent expiration is pivotal. The drug was disclosed in 1962 and became generic in many regions by the early 2000s. Patent expiration eliminated exclusivity, leading to significant price erosion and increased generic competition.

• Patent Status: Non-patented in most jurisdictions since the early 2000s.
• Market Exclusivity: Lost over two decades ago.
• Impact on Revenue: U.S. sales declined from a peak of approximately $340 million in 2009 to under $50 million in 2022[1].

Despite generic competition, LASIX retains a market in developing countries where it is still prescribed due to its low cost and established efficacy.

What Are the Core Market and Usage Fundamentals?

• Indications: Edema associated with congestive heart failure, liver cirrhosis, renal disease; hypertension if other agents contraindicated.
• Prescriptions: Still prescribed in multiple countries; however, usage is waning in mature markets.
• Generics: Multiple manufacturers produce furosemide, driving down unit prices.
• Pricing Trends: In the U.S., unit prices for generics range from $0.05 to $0.15 per tablet, significantly lower than branded versions previously sold at higher margins.

What Regulatory and Supply Chain Factors Affect LASIX?

• Regulatory Environment: No recent regulatory barriers in major markets; however, quality control issues with some generic manufacturers have prompted recalls.
• Supply Chain: Concentration among key generic producers increases vulnerability to manufacturing disruptions.
• Patent/IP Initiatives: No active patent protections or new formulations sourced from patenting efforts.

Are There Potential Innovations or Market Extensions?

Limited innovation has occurred around LASIX due to its generic status and mature formulation. Some development activity exists around alternative diuretics with better safety profiles, reducing the demand for traditional LASIX formulations.

What Is the Risk Profile for Investors?

• Market Decline: Continued decline in mature markets limits revenue growth.
• Regulatory Risks: Potential recalls or quality issues may temporarily disrupt supply.
• Generic Competition: Low-cost manufacturing further suppresses margins.
• Emerging Markets: Growth potential exists where healthcare infrastructure adopts cheaper generic formulations.

What Are the Key Financial Indicators?

Indicator	Data (2022)	Commentary
Global sales	<$50 million (U.S.)	Reflects decline from historic highs
Market share (global)	Low in established markets	Outcompeted by newer diuretics
Number of generic manufacturers	10+ globally	Ensuring price competition
Price per unit	~$0.05–$0.15 per tablet	Margins under pressure

Final Evaluation

Investing directly in LASIX as a pharmaceutical product is unlikely to yield significant growth. Opportunities exist in niche markets or emerging regions, but for consistent revenue, diversification within portfolio companies is advised.

Key Takeaways

• Patent expiration in early 2000s led to widespread generic adoption.
• Current revenue mainly from low-cost generics in developing markets.
• Limited innovation means no significant pipeline development.
• Supply chain and quality control issues pose supply risks.
• Growth prospects are confined primarily to markets with limited access to newer therapies.

FAQs

1. Is LASIX still widely prescribed?
It remains prescribed in certain regions, especially where affordability constrains newer alternatives.

2. Are there patent protections that could be leveraged for future revenues?
No, LASIX's patent expired decades ago; no new patent protections are active.

3. Has any new formulation or delivery method been developed?
No significant innovations have emerged; formulations remain standard.

4. What are the main regulatory concerns?
Quality control issues with generic manufacturers and occasional recalls.

5. Can LASIX undergo reformulation to extend market life?
Reformulation is unlikely due to the availability of cheaper, similar generics and low profitability.

References

[1] IQVIA, 2023. Pharmaceutical Sales Data.