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 and Validus Pharms and is included in three NDAs.

The generic ingredient in LASIX is furosemide. There are twenty-two drug master file entries for this compound. Fifty-five 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 HIKMA on November 10^th, 1983.

Summary for LASIX

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Patent Applications:	3,214
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	No	No
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for LASIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-003	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	LASIX	furosemide	INJECTABLE;INJECTION	016363-001	Approved Prior to Jan 1, 1982
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-001	Approved Prior to Jan 1, 1982
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-002	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	LASIX	furosemide	SOLUTION;ORAL	017688-001	Approved Prior to Jan 1, 1982

International Patents for LASIX

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

Country	Patent Number	Title	Estimated Expiration
Hungary	171769	SPOSOB POLUCHENIJA LECHEBNYKH PREPARATOV SODERZHAHHIKH N-/2-FURFURIL/-4-KHLOR-5-SUL'FAMOIL-ANTRANILOVOJ KISLOTY S VYTJANUTYM EHFFEKTOM (PROCESS FOR PREPARING PHARMACEUTICAL PREPARATIONS CONTAINING N-/2-FURFURYL/-4-CHLORO-5-SULPHAMOYL-ANTRANILIC ACID WITH A RETARD EFFECT)
United Kingdom	1478715
Belgium	819294
Netherlands	7411269
Japan	S5076217

LASIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of LASIX

Introduction to LASIX

LASIX, known generically as furosemide, is a potent diuretic used to treat various medical conditions, including heart failure, hypertension, and edema. Its market dynamics are influenced by several key factors, including regulatory environments, competitive landscapes, and ongoing research and development.

Market Drivers

The LASIX market is primarily driven by the rising prevalence of chronic diseases such as heart failure and hypertension. As the global population ages, the incidence of these conditions increases, leading to a heightened demand for effective diuretics like LASIX. Here are some key drivers:

• Increasing Geriatric Population: The growing elderly population is a significant driver, as this demographic is more prone to chronic diseases that require diuretic treatment[1][3].
• Advancements in Healthcare Infrastructure: Improved healthcare infrastructure and increased awareness about cardiovascular health have propelled the demand for LASIX. Early diagnosis and preventive care initiatives have resulted in increased prescriptions for managing acute and chronic conditions[1].
• Hospital Admissions: The rising trend of hospital admissions related to heart failure has prompted healthcare providers to leverage LASIX as a first-line treatment option[1].

Market Restraints

Despite its established role, the LASIX market faces several challenges that could impede growth:

• Adverse Side Effects: Potential side effects such as electrolyte imbalances, dehydration, and ototoxicity may limit its use in certain patient populations[1].
• Alternative Therapies: The availability of alternative diuretics and emerging therapies presents stiff competition to LASIX, leading to potential market share erosion[1].
• Regulatory Requirements: Stringent regulatory requirements and lengthy approval processes for new formulations can delay the introduction of innovative products, creating barriers for new entrants[1].
• Price Sensitivity: Healthcare providers, especially in developed regions with strict cost-containment policies, are price-sensitive, which can pose challenges to market expansion[1].

Market Opportunities

The LASIX market presents several lucrative opportunities for stakeholders:

• Advancements in Formulations: Ongoing research and development aimed at optimizing LASIX formulations, such as extended-release or combination therapies, could enhance patient adherence and efficacy. For example, scPharmaceuticals is developing an auto-injector for subcutaneous administration of furosemide, which could reduce manufacturing costs and offer treatment flexibility[2][4].
• Emerging Markets: Regions like Asia-Pacific and Latin America are witnessing significant healthcare investments and improved access to medications, paving the way for market expansion. Countries such as India and China are seeing a surge in demand for LASIX as they develop their healthcare infrastructure[1][3].
• Comorbidities: The rising prevalence of comorbidities, especially among the elderly population, presents an opportunity for healthcare providers to integrate LASIX into comprehensive treatment protocols[1].

Competitive Landscape

The competitive landscape of the LASIX market is dynamic and competitive:

• Established Players: Major pharmaceutical companies like Sanofi, Pfizer, and Teva Pharmaceuticals dominate the market with their extensive product portfolios and established distribution networks. These companies invest heavily in research and development to innovate and improve their offerings[1].
• Generic Versions: The rise of generic versions of LASIX has intensified competition, forcing established companies to adapt their pricing strategies and enhance value propositions[1].
• New Entrants: New players focusing on niche markets or specialized formulations also pose a threat to traditional players, fostering a competitive environment. Strategic collaborations and partnerships are increasingly common as companies seek to leverage complementary strengths and enhance market penetration[1].

Regional Dynamics

The LASIX market exhibits distinct regional dynamics:

• North America: Dominates the market due to advanced healthcare systems and a high incidence of cardiovascular diseases. The presence of key players and robust research activities further bolster the region's market share[1].
• Europe: Follows closely, with a strong emphasis on regulatory compliance and patient safety[1].
• Asia-Pacific: Emerging as a significant growth area due to increasing healthcare access, rising disposable incomes, and a growing geriatric population. Countries like India and China are key drivers in this region[1][3].

Financial Trajectory

The financial performance of companies involved in the LASIX market is influenced by several factors:

• Revenue Growth: scPharmaceuticals, for example, reported net revenue of $6.1 million for FUROSCIX (their furosemide product) in the first quarter of 2024, despite challenges such as the Change Healthcare cyberattack and seasonality. The company saw a 28% sequential increase in total doses written and a 15% increase in doses filled compared to the fourth quarter of 2023[2].
• Expenses and Losses: scPharmaceuticals reported a net loss of $14.1 million for the first quarter of 2024, reflecting significant research and development expenses and selling, general, and administrative costs. The company's gross-to-net discount rose to 19% during the first quarter, with expectations that it will increase further[2].
• Cash and Equivalents: scPharmaceuticals ended the first quarter of 2024 with $58.4 million in cash and cash equivalents, indicating a robust financial position to support ongoing development and commercialization efforts[2].

Future Outlook

The future outlook for the LASIX market appears positive:

• Growing Demand: The rising global burden of chronic diseases and the increasing geriatric population will continue to drive demand for effective diuretics like LASIX[1].
• Technological Advancements: Ongoing advancements in medical technology and pharmaceutical research promise to deliver improved formulations and delivery methods, enhancing patient outcomes and adherence[1].
• Market Expansion: The expansion of healthcare access in emerging markets presents significant opportunities for market penetration. As healthcare providers increasingly prioritize cost-effective treatments, LASIX will likely remain a cornerstone in the management of fluid-related conditions[1].

Key Takeaways

• The LASIX market is driven by the rising prevalence of chronic diseases and advancements in healthcare infrastructure.
• Despite its established role, the market faces challenges such as adverse side effects and competition from alternative therapies.
• Emerging markets and advancements in drug formulations present lucrative opportunities.
• The competitive landscape is characterized by established players and new entrants, with a focus on strategic collaborations and innovative products.
• The financial trajectory of companies like scPharmaceuticals reflects revenue growth, significant expenses, and a robust financial position to support development and commercialization.

FAQs

What are the primary drivers of the LASIX market?

The primary drivers include the rising prevalence of chronic diseases such as heart failure and hypertension, advancements in healthcare infrastructure, and increased awareness about cardiovascular health.

What are the main restraints to the LASIX market?

The main restraints include potential adverse side effects, competition from alternative therapies, stringent regulatory requirements, and price sensitivity among healthcare providers.

Which regions are expected to drive the growth of the LASIX market?

North America currently dominates the market, but the Asia-Pacific region is emerging as a significant growth area due to increasing healthcare access and a growing geriatric population.

How is scPharmaceuticals contributing to the LASIX market?

scPharmaceuticals is developing innovative products such as an auto-injector for subcutaneous administration of furosemide, which could reduce manufacturing costs and offer treatment flexibility. They reported significant revenue growth and are expanding their commercialization efforts despite facing challenges.

What is the future outlook for the LASIX market?

The future outlook is positive, driven by the growing demand for effective diuretics, technological advancements, and the expansion of healthcare access in emerging markets.

Sources

1. Data Horizon Research: Lasix Market Size, Growth and Analysis Report - 2033
2. scPharmaceuticals Inc.: Reports First Quarter 2024 Financial Results
3. Data Bridge Market Research: Global Frusemide Market - Industry Trends and Forecast to 2028
4. scPharmaceuticals: Announces First Participant Enrolled in Pivotal Pharmacokinetic Study
5. Market Research Intellect: Lasix Market Size And Projection - Market Research Intellect