TORSEMIDE - Generic Drug Details

What are the generic drug sources for torsemide and what is the scope of freedom to operate?

Torsemide is the generic ingredient in three branded drugs marketed by Roche, Am Regent, Hikma, Pharmobedient, Sarfe Pharms, Aurobindo Pharma, Corepharma, Hetero Labs Ltd Iii, Pliva Pharm Ind, Strides Pharma Intl, Sun Pharm Inds, and Teva, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Torsemide has two patent family members in two countries.

There are sixteen drug master file entries for torsemide. Twenty-one suppliers are listed for this compound.

Summary for TORSEMIDE

International Patents:	2
US Patents:	1
Tradenames:	3
Applicants:	12
NDAs:	14
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	31
Drug Prices:	Drug price trends for TORSEMIDE
Drug Sales Revenues:	Drug sales revenues for TORSEMIDE
What excipients (inactive ingredients) are in TORSEMIDE?	TORSEMIDE excipients list
DailyMed Link:	TORSEMIDE at DailyMed

See drug prices for TORSEMIDE

See drug sales revenues for TORSEMIDE

Recent Clinical Trials for TORSEMIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stacy Johnson	PHASE3
Sarfez Pharmaceuticals, Inc.	PHASE3
Sarfez Pharmaceuticals, Inc.	PHASE4

See all TORSEMIDE clinical trials

Pharmacology for TORSEMIDE

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

US Patents and Regulatory Information for TORSEMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	TORSEMIDE	torsemide	TABLET;ORAL	076110-001	May 14, 2002		DISCN	No	No
Corepharma	TORSEMIDE	torsemide	TABLET;ORAL	076894-004	May 31, 2005	AB	RX	No	No
Teva	TORSEMIDE	torsemide	TABLET;ORAL	076110-004	May 14, 2002		DISCN	No	No
Aurobindo Pharma	TORSEMIDE	torsemide	TABLET;ORAL	078249-004	Oct 17, 2007	AB	RX	No	No
Strides Pharma Intl	TORSEMIDE	torsemide	TABLET;ORAL	090613-004	Mar 22, 2011	AB	RX	No	No
Strides Pharma Intl	TORSEMIDE	torsemide	TABLET;ORAL	076226-001	May 27, 2003	AB	RX	No	No
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993		DISCN	Yes	No

Expired US Patents for TORSEMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-003	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993
Roche	DEMADEX	torsemide	SOLUTION;INTRAVENOUS	020137-002	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-004	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-003	Aug 23, 1993

International Patents for TORSEMIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3065718	FORMULATIONS À LIBÉRATION CONTRÔLÉE COMPRENANT DU TORSÉMIDE (CONTROLLED-RELEASE FORMULATIONS COMPRISING TORSEMIDE)
World Intellectual Property Organization (WIPO)	2015050570

Market Dynamics and Financial Trajectory for Torsemide

Last updated: February 19, 2026

What Are the Key Market Drivers for Torsemide?

Torsemide is a loop diuretic primarily used to treat edema associated with heart failure, hepatic cirrhosis, and renal disease. Its unique pharmacokinetic profile, including longer half-life and once-daily dosing compared to furosemide, has influenced its market positioning. The drug is approved in several countries but faces competition from other loop diuretics.

Market Drivers:

• Growing prevalence of heart failure: The global heart failure market is projected to reach $11.4 billion by 2030, with diuretics like torsemide being essential components in management protocols. The increase in aging populations and cardiovascular disease prevalence drives demand.

• Enhanced clinical data: Studies indicating potential advantages over existing diuretics, such as improved bioavailability and reduction in hospitalization rates, support increased off-label use and prescriber confidence.

• Patent expiration and generics: The patent for torsemide expired in the late 2000s, leading to an influx of generic versions, reducing costs and expanding access. Market penetration hinges on generic adoption.

• Regulatory approval variations: Approval status differs across regions; torsemide is approved in the U.S., Japan, and certain European countries but not universally. This regulatory landscape influences market penetration.

• Country-specific prescribing patterns: Countries with established diuretic preferences (e.g., furosemide) exhibit slower transition to torsemide unless compelling clinical evidence emerges.

How Is the Competitive Landscape Evolving?

Torsemide faces competition from:

• Furosemide: The most widely prescribed loop diuretic due to longstanding use and cost advantages in many markets.
• Bumetanide: An alternative loop diuretic with similar applications.
• Ethacrynic acid: Used in cases of sulfa allergies but less common due to side effect profile.

Emerging research on torsemide’s benefits has not yet significantly shifted prescribing habits. Some studies suggest that torsemide may reduce hospitalizations in heart failure patients, which could influence future prescribing trends.

Market Positioning:

• Dominates in niche markets with specific clinical protocols.
• Limited by lack of robust, large-scale comparative clinical trials that establish superiority over other diuretics.

What Is the Financial Outlook for Torsemide?

Revenue Estimates:

• The global diuretic market was valued at approximately $6.2 billion in 2022.
• Torsemide accounts for an estimated 4-8% of this market, with revenues around $250 million to $500 million, primarily generated from North America, Europe, and Japan.
• The market is projected to grow at a compound annual growth rate (CAGR) of approximately 4% from 2023 to 2028, driven by increasing cardiovascular disease prevalence.

Pricing Dynamics:

• Patents' expiration led to generic entry, significantly reducing prices.
• Current prices vary by region, with generics priced 20-50% lower than branded formulations.
• Market penetration depends heavily on clinician acceptance and insurance reimbursement policies.

Regulatory and R&D Impact:

• Efforts to expand indications through clinical trials (e.g., for heart failure management) could stimulate revenues.
• New formulations or combination therapies may open additional revenue streams but are not yet in advanced development stages.

How Do Regional Policies Affect Market Expansion?

• United States: Approved and marketed; reimbursement by Medicare and private insurers influence sales positively.
• Japan: Widely used; government policies favor aging population management.
• European Union: Approved in some countries; diverging regulatory statuses affect availability.
• Emerging Markets: Limited approval and low awareness; growth potential exists contingent on regulatory acceptance and pricing strategies.

What Are the Risks and Opportunities?

Risks:

• Competition from well-established diuretics.
• Limited large-scale comparative trials to demonstrate clinical superiority.
• Regulatory delays or restrictions in certain regions.
• Pricing pressures due to generic proliferation.

Opportunities:

• Conducting rigorous clinical trials to establish benefits over other diuretics.
• Expanding indications beyond edema management in heart failure.
• Developing improved formulations to enhance compliance.
• Marketing to regions with aging populations and rising cardiovascular disease rates.

Key Takeaways

• Torsemide's market is influenced by its pharmacokinetic profile, clinical data, and regional approval variances.
• Revenue remains modest relative to the broader diuretic market, with growth driven by aging populations and heart failure prevalence.
• Competition from established generic drugs and lack of large-scale comparative trials are significant barriers.
• Regulatory environments and healthcare policies shape regional market dynamics.
• Innovation and expanded clinical evidence are needed to improve market share.

FAQs

1. How does torsemide compare to furosemide in clinical efficacy?
Clinical trials suggest torsemide may have improved bioavailability and potentially better outcomes in heart failure management, but large-scale evidence remains limited.

2. What regions have regulatory approval for torsemide?
It is approved in the U.S., Japan, and select European countries but lacks approval in many others, including some markets in Latin America and Africa.

3. How are patent expirations impacting torsemide sales?
Patent expirations have allowed generic manufacturers to enter the market, decreasing prices and squeezing branded revenues.

4. What investment opportunities exist related to torsemide?
Potential exists in clinical development for new indications, formulation improvements, and regional market expansion, especially where aging populations increase cardiovascular disease burden.

5. What future trends could influence torsemide’s market?
Growing evidence supporting its benefits, regulatory approvals in new markets, and advancements in formulation may shape its market trajectory.

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References:

1. MarketWatch. (2023). Diuretics Market Size, Share & Trends Analysis Report.
2. Grand View Research. (2022). Cardiovascular Drugs Market Size & Trends.
3. U.S. Food and Drug Administration. (2022). Approved Drug Products.
4. World Health Organization. (2021). Cardiovascular Diseases Fact Sheet.
5. Evaluate Pharma. (2023). Therapeutic Area Reports: Cardiovascular.