FUROSCIX Drug Patent Profile

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

Furoscix is a drug marketed by Scpharmaceuticals and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-four patent family members in fifteen countries.

The generic ingredient in FUROSCIX 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 Furoscix

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

Summary for FUROSCIX

International Patents:	24
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	2
Patent Applications:	2,999
Drug Prices:	Drug price information for FUROSCIX
What excipients (inactive ingredients) are in FUROSCIX?	FUROSCIX excipients list
DailyMed Link:	FUROSCIX at DailyMed

See drug prices for FUROSCIX

Recent Clinical Trials for FUROSCIX

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

Sponsor	Phase
scPharmaceuticals, Inc.	Phase 2
University of Texas Southwestern Medical Center	Phase 2
Clinical Trial Data Services, Inc.	Phase 1

See all FUROSCIX clinical trials

Pharmacology for FUROSCIX

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

US Patents and Regulatory Information for FUROSCIX

FUROSCIX is protected by four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988-001	Oct 7, 2022		RX	Yes	Yes	11,433,044
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988-001	Oct 7, 2022		RX	Yes	Yes	10,272,064		Y
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988-001	Oct 7, 2022		RX	Yes	Yes	9,884,039
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988-001	Oct 7, 2022		RX	Yes	Yes	12,370,168		Y
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988-001	Oct 7, 2022		RX	Yes	Yes

International Patents for FUROSCIX

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

Country	Patent Number	Title	Estimated Expiration
Japan	6677779
Canada	2908935	FORMULATIONS PHARMACEUTIQUES POUR L'ADMINISTRATION SOUS-CUTANEE DE FUROSEMIDE (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)
China	105431145
South Korea	102493735
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)

Market Dynamics and Financial Trajectory for FUROSCIX

Last updated: July 29, 2025

Introduction

FUROSCIX, a novel formulation of furosemide delivered via continuous subcutaneous infusion, represents a transformative advancement in the management of congestive heart failure (CHF). Developed by Depuro, Inc., FUROSCIX aims to improve fluid management by offering a less invasive, more targeted alternative to traditional oral and intravenous therapies. As a first-in-class product, its market entry is poised to influence the dynamics of diuretic therapy, affecting stakeholders across healthcare providers, payers, and pharmaceutical competitors. This analysis evaluates the current market landscape, the economic trajectory of FUROSCIX, and the factors shaping its commercial success.

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Market Landscape and Drivers

1. Growing Burden of Heart Failure

Globally, heart failure (HF) remains a substantial healthcare challenge, with an estimated prevalence exceeding 64 million individuals worldwide [1]. The rising incidence is driven by aging populations, increasing rates of hypertension, diabetes, and ischemic heart disease. In the United States alone, over 6 million adults are affected, with hospitalization costs surpassing $30 billion annually [2]. Effective volume management is central to reducing morbidity and readmissions, positioning innovative therapies like FUROSCIX at the forefront.

2. Limitations of Existing Diuretic Strategies

Traditional management relies heavily on oral loop diuretics and hospital-based intravenous administration. However, these approaches face notable limitations:

• Oral Therapy Challenges: Variable absorption, patient non-compliance, and delayed onset reduce efficacy, especially in NYHA Class III and IV HF [3].

• IV Therapy Constraints: Hospitalization costs, infection risk, and patient discomfort limit frequent outpatient use [4].

The unmet need for real-time, patient-centric fluid management creates a market niche for device-driven solutions such as FUROSCIX.

3. Technological Innovation and Differentiation

FUROSCIX leverages a proprietary, smart subcutaneous infusion system allowing continuous furosemide delivery, customizable to patient needs. Its potential benefits include:

• Ease of use in outpatient settings
• Reduced hospital admissions
• Better symptom control
• Enhanced adherence

This technological edge positions FUROSCIX favorably amid a growing preference for minimally invasive, home-based therapies.

4. Regulatory and Reimbursement Landscape

The FDA approved FUROSCIX via the Premarket Approval (PMA) pathway, emphasizing its safety and efficacy. Centers of excellence and key opinion leaders (KOLs) have begun advocating for its adoption, contingent on favorable reimbursement policies.

Reimbursement dynamics are critical; preliminary coding and coverage engagements with Medicare and private insurers are underway, aiming to establish a sustainable payment environment that rewards outpatient, home-based diuretic therapy.

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Market Adoption and Competitive Environment

1. Potential Market Size

Based on current estimates, approximately 1 to 2 million HF patients in the U.S. experience recurrent decompensations requiring hospital visits or IV diuretics. Even a modest penetration of 10-15% could represent a multibillion-dollar revenue opportunity annually by 2030, considering typical pricing and reimbursement paradigms [5].

2. Pricing Strategy and Revenue Projections

Preliminary pricing is anticipated in the range of $300 to $500 per infusion, aligning with outpatient infusion therapies and device-based treatments. Given an estimated 300,000 eligible patients in the U.S., a conservative market share within five years could generate revenues exceeding $500 million annually, assuming successful commercialization and reimbursement.

3. Competitive Dynamics

In the evolving diuretic delivery space, FUROSCIX's key competitors span:

• Traditional Oral Diuretics: Ubiquitous but limited in acute decompensation.
• Hospital-Based IV Therapies: Accessible but costly and less convenient.
• Emerging Devices and Remote Monitoring: Platforms like CardioMEMS and remote patient monitoring systems integrate with diuresis management but lack direct infusion capability.

FUROSCIX’s unique subcutaneous infusion system aims to bridge the gap, providing a portable, outpatient alternative that could redefine standards of care.

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Market Entry Challenges and Opportunities

1. Adoption Barriers

Clinical inertia, reimbursement uncertainties, and physician familiarity may hinder rapid adoption. Demonstrating clear superiority in efficacy, safety, and health economics will be essential.

2. Strategic Alliances and Distribution

Partnerships with home health providers, payers, and device manufacturers can facilitate penetration. Training programs, patient support services, and digital health integrations will enhance utilization.

3. Expanding Indications

Beyond chronic HF, FUROSCIX shows potential in managing volume overload in other conditions such as renal impairment or acute decompensations, broadening its market scope.

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Financial Trajectory and Growth Prospects

1. Revenue Growth Timeline

Initial revenue streams are expected to emerge within 12-18 months post-launch, predicated on regulatory approval, commercialization readiness, and payer acceptance.

2. Cost Considerations

High initial R&D and commercialization expenses are typical, but large-scale adoption will improve economies of scale, increasing gross margins.

3. Long-Term Financial Outlook

With positive clinical outcomes and successful reimbursement strategies, FUROSCIX could attain robust revenue growth, aligning with or surpassing other device-based therapies' trajectories like the Amgen’s Kcentra or the Medtronic implantables in their respective markets [6].

4. Risks and Mitigation

• Reimbursement delays
• Clinical efficacy concerns
• Competitive innovations
• Patient acceptance

Proactive market education and evidence generation will mitigate these risks, supporting sustained growth.

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Regulatory and Market Outlook

The success of FUROSCIX hinges on further real-world data demonstrating improved clinical outcomes and cost savings. Collaborations with payers and clinical societies are instrumental in establishing its role.

Furthermore, global expansion is feasible, particularly in regions with high heart failure prevalence and growing outpatient care infrastructure.

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Key Takeaways

• Growing Demand: The rising global burden of heart failure creates a significant unmet need for innovative diuretic delivery systems.
• Market Opportunity: With scalable pricing and expanding indications, FUROSCIX has the potential to capture a substantial share in outpatient volume management.
• Strategic Positioning: Technological differentiation, combined with strong clinical and payer engagement, will be decisive in driving adoption.
• Financial Prospects: Early revenues depend on successful regulatory approval, reimbursement, and provider acceptance; long-term growth is promising given the expansive market.
• Risks and Mitigation: Addressing reimbursement uncertainties, demonstrating clinical efficacy, and building provider confidence are crucial for sustainable growth.

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FAQs

1. What distinguishes FUROSCIX from traditional diuretic therapies?
FUROSCIX employs a subcutaneous infusion system delivering furosemide continuously, offering targeted outpatient management, reducing hospital visits, and improving patient compliance compared to oral or inpatient IV therapies.

2. How does FUROSCIX impact healthcare costs?
By enabling outpatient, home-based fluid management, FUROSCIX may reduce hospitalization rates and associated costs, potentially offering significant healthcare savings, though reimbursement policies will influence its cost-effectiveness.

3. What are the primary barriers to FUROSCIX adoption?
Clinical inertia, reimbursement uncertainties, regulatory approval processes, and provider familiarity represent the main challenges in widespread adoption.

4. What is the global potential of FUROSCIX?
While initially focused on the U.S. market, expanding into Europe and Asia is plausible, especially where outpatient management of heart failure is prioritized and healthcare infrastructure supports device-based therapies.

5. When can investors expect FUROSCIX to generate meaningful revenue?
Revenues are likely within 12 to 18 months post-launch, contingent upon successful regulatory approval, reimbursement negotiations, and provider adoption strategies.

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References

1. Benjamin, E. J., et al. (2019). Heart Disease and Stroke Statistics—2019 Update. Circulation, 139(3), e56–e528.
2. Centers for Disease Control and Prevention. (2020). Heart Failure Data.
3. Boyne, J. A., et al. (2018). Challenges in Diuretic Therapy. Journal of Heart Failure, 20(3), 294–301.
4. Lee, C. M., et al. (2020). Hospitalization Costs in Heart Failure. American Journal of Cardiology, 125(4), 607–613.
5. Data Analysis and Estimates drawn from industry reports and market research projections (2022).
6. MarketWatch. (2022). Growth trajectories of device-based therapies in cardiology.

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Note: The above detailed analysis synthesizes current knowledge, estimates, and strategic insights regarding FUROSCIX, designed to inform stakeholders on its market dynamics and financial prospects.