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 three branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, Areva Pharms, Astrazeneca, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Meitheal, Saba Ilac Sanayive, Sagent, Smith And Nephew, Warner Chilcott, Watson Labs, Wockhardt, Wyeth Ayerst, Sanofi Aventis Us, Pharmobedient Cnsltg, Scpharmaceuticals, Ani Pharms, Chartwell Rx, Epic Pharma Llc, Esjay Pharma, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Mylan, Prinston Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs Teva, and Validus Pharms, and is included in sixty-nine NDAs. There are three 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. Fifty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for FUROSEMIDE

International Patents:	24
US Patents:	3
Tradenames:	3
Applicants:	43
NDAs:	69
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	269
Patent Applications:	7,105
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
National Heart, Lung, and Blood Institute (NHLBI)	N/A
University of Delaware	N/A
University Hospital, Tours	Phase 3

See all FUROSEMIDE clinical trials

Generic filers with tentative approvals for FUROSEMIDE

Applicant	Application No.	Strength	Dosage Form
		80MG PER 2.67ML	INJECTION;SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Hospira	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	070578-001	Jul 8, 1987		DISCN	No	No
Watson Labs	FUROSEMIDE	furosemide	TABLET;ORAL	070450-001	Nov 22, 1985		DISCN	No	No
Leading	FUROSEMIDE	furosemide	TABLET;ORAL	077293-003	Nov 9, 2005	AB	RX	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	016273-003	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
Hong Kong	1221152	用於呋塞米的皮下施用的藥物製劑 (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)
Spain	2823589
Canada	2908935	FORMULATIONS PHARMACEUTIQUES POUR L'ADMINISTRATION SOUS-CUTANEE DE FUROSEMIDE (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)

FUROSEMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Furosemide

Introduction to Furosemide

Furosemide, commonly known by its trade name Lasix, is a potent loop diuretic used to treat various medical conditions, including edema, hypertension, and heart failure. It works by blocking the absorption of sodium, chloride, and water in the kidney tubules, leading to increased urine output.

Market Size and Forecast

The global furosemide market is experiencing significant growth. As of 2021, the furosemide injection market was valued at USD 659.73 million and is projected to reach USD 954.07 million by 2030, growing at a CAGR of 4.53% from 2023 to 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the furosemide market:

Increasing Incidence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases such as chronic heart failure, hypertension, and edema is a key driver. Furosemide is often used to reduce fluid excess and improve symptoms in these conditions[1].

Aging Population

The global aging population is more vulnerable to cardiovascular diseases, increasing the demand for diuretics like furosemide[1].

Technological Innovations and Healthcare Development

Advancements in healthcare technology and the expansion of modern medical facilities in emerging nations have contributed to market growth. Government programs aimed at increasing access to essential medications also play a crucial role[1].

Growing Awareness and Medical Insurance

Increased awareness about fluid management and the availability of medical insurance have further boosted the market. In the Asia-Pacific region, for example, there is a rising awareness about managing chronic diseases, which has driven the demand for furosemide[3].

Market Segmentation

By Type

The furosemide injection market is segmented into 20mg/2ml, 40mg/40ml, and 100mg/10ml. The 40mg/40ml segment held a significant market share in 2021 due to its efficacy and standardized dose form, making it ideal for healthcare professionals[1].

By Application

The market is segmented into hospitals, clinics, and recovery centers. Hospitals dominate the market due to the critical role furosemide plays in treating severe medical conditions such as heart failure, renal disease, and edema[1].

By Geography

The Asia-Pacific region accounted for a significant market share in 2021, driven by the high prevalence of heart failure, hypertension, and renal disease. North America is also expected to hold a large market share due to the increased number of specialty clinics and research institutions[1][3].

Financial Trajectory

Revenue and Sales

Companies like scPharmaceuticals Inc., which markets FUROSCIX (a formulation of furosemide), have seen significant revenue growth. For the first quarter of 2024, scPharmaceuticals reported net FUROSCIX revenue of $6.1 million, despite challenges such as the Change Healthcare cyberattack and seasonality[2].

Expansions and Development

scPharmaceuticals is advancing several long-term growth initiatives, including the potential expansion of the FUROSCIX indication to include New York Heart Association (NYHA) Class IV heart failure patients and chronic kidney disease. The company has also initiated a pharmacokinetic study to support the development of a low-volume auto-injector for FUROSCIX[2].

Financial Performance

Despite reporting a net loss of $14.1 million for the first quarter of 2024, scPharmaceuticals ended the quarter with cash and cash equivalents of $58.4 million. The company anticipates that gross-to-net discounts will increase over time, potentially reaching 30-35% by the end of the year[2].

Challenges and Restraints

Alternative Treatments

The availability of alternative diuretics and drugs with similar therapeutic effects can limit the market penetration of furosemide. Physicians may opt for other treatments, which can reduce the demand for furosemide[1].

Regulatory and Economic Factors

Stringent FDA regulations for drug approval, increased medical expenses, and lack of patient awareness can also hamper market growth. Additionally, product recalls and off-label drug usage can pose challenges[3].

Opportunities and Future Outlook

Untapped Markets

The Asia-Pacific region offers significant untapped opportunities due to its large population, rising urbanization, and increasing healthcare infrastructure. Technological developments and partnerships, such as the use of Ligand's Captisol technology, are expected to boost market growth[3].

Expanding Indications

The potential expansion of furosemide indications to include NYHA Class IV heart failure patients and chronic kidney disease presents opportunities for market growth. Innovations in delivery systems, such as the development of low-volume auto-injectors, will also provide treatment flexibility and enhance market prospects[2].

Key Takeaways

• The furosemide market is growing at a CAGR of 4.53% from 2023 to 2030.
• Drivers include increasing cardiovascular diseases, an aging population, and advancements in healthcare.
• The market is segmented by type, application, and geography, with the 40mg/40ml segment and hospital application dominating.
• Companies like scPharmaceuticals are seeing revenue growth and are investing in long-term growth initiatives.
• Challenges include alternative treatments, regulatory hurdles, and economic factors.
• Opportunities lie in untapped markets, expanding indications, and technological innovations.

FAQs

What is the projected market size of the furosemide injection market by 2030?

The furosemide injection market is expected to reach USD 954.07 million by 2030[1].

What are the main drivers of the furosemide market?

The main drivers include the increasing incidence of cardiovascular diseases, an aging population, technological innovations, and government campaigns to increase access to essential medications[1].

Which segment dominates the furosemide injection market by application?

The hospital segment dominates the market due to the critical role furosemide plays in treating severe medical conditions[1].

What are the challenges facing the furosemide market?

Challenges include the availability of alternative treatments, stringent FDA regulations, increased medical expenses, and lack of patient awareness[1][3].

What are the future outlook and opportunities for the furosemide market?

The future outlook is positive with opportunities in untapped markets, expanding indications, and technological innovations such as new delivery systems[2][3].

Cited Sources:

1. Verified Market Research: Furosemide Injection Market Size, Share, Trends & Forecast[1].
2. scPharmaceuticals Inc.: Reports First Quarter 2024 Financial Results[2].
3. Data Bridge Market Research: Global Frusemide Market - Industry Trends and Forecast to 2028[3].