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 three 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-five 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 HIKMA on November 10^th, 1983.

Summary for FUROSCIX

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	2
Patent Applications:	3,302
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
CSSi Life Sciences	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 three 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
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988-001	Oct 7, 2022		RX	Yes	Yes
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
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)

FUROSCIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FUROSCIX

Introduction

FUROSCIX, a pharmaceutical product developed by scPharmaceuticals Inc., has been making significant strides in the market, particularly in the treatment of heart failure and other related conditions. Here, we will delve into the market dynamics and financial trajectory of FUROSCIX, highlighting key milestones, financial performance, and future prospects.

Market Acceptance and Growth

Increasing Prescribers and Doses

The number of unique prescribers of FUROSCIX has seen a notable increase. By the end of the second quarter of 2024, the number of unique prescribers rose by 24% to 2,713, up from 2,183 in the first quarter[1][2][4]. Additionally, the number of doses filled has consistently increased, with a 15% sequential growth to 9,300 doses in Q2 2024, and further rising to 10,800 doses in Q3 2024[1][2][3].

Doses Per Prescription

The average number of doses per prescription has also increased, indicating better patient adherence. This metric rose from 6.1 doses per prescription in Q1 2024 to 6.3 in Q2 2024, and further to 6.8 in Q3 2024[1][3][4].

Financial Performance

Revenue Growth

FUROSCIX has demonstrated strong revenue growth. In Q2 2024, net FUROSCIX revenue increased by 33% sequentially to $8.1 million, and by Q3 2024, it rose to $10.0 million, representing a 24% increase from Q2 2024[1][2][3].

Gross-to-Net Discount Improvement

The gross-to-net discount, which reflects the difference between the list price and the net price after discounts and rebates, improved significantly. It reduced from 19% in Q1 2024 to 8% in Q2 2024, although it slightly increased to 15.7% in Q3 2024[1][2][4].

Regulatory Advancements

FDA Approvals and sNDA Submissions

The FDA approved the expansion of the FUROSCIX indication to include patients with New York Heart Association (NYHA) Class IV chronic heart failure, a significant milestone for the product[1][2][5]. Additionally, the FDA accepted the Supplemental New Drug Application (sNDA) for the treatment of edema due to fluid overload in patients with chronic kidney disease (CKD), with a target action date set for March 6, 2025[1][2].

Positive PK/PD Data

scPharmaceuticals announced positive topline pharmacokinetic/pharmacodynamic (PK/PD) data for the FUROSCIX autoinjector, which met primary and secondary endpoints. This development is crucial for future submissions and market expansion[1][2].

Financing and Cash Position

Recent Financing Deals

In August 2024, scPharmaceuticals completed financing deals totaling up to $175 million, including $75 million in senior debt, $50 million in synthetic royalty, and approximately $50 million in equity funding. These transactions extended the company's cash runway through expected profitability[1][2][3].

Cash and Equivalents

As of the end of Q2 2024, scPharmaceuticals had $38.5 million in cash, cash equivalents, and short-term investments, down from $76.0 million at the end of 2023. However, the recent financing deals have significantly bolstered the company's financial position[1][2].

Operational Costs and Net Loss

Increasing Operational Costs

While revenue has been growing, so have the operational costs. The net loss for Q2 2024 was $17.1 million, compared to $14.2 million in Q2 2023. This increase is largely due to higher selling, general, and administrative expenses[1][2].

Research and Development Expenses

Research and development expenses, although slightly decreased in Q2 2024, remain a significant component of the company's expenditures. These costs are crucial for the ongoing development and lifecycle management of FUROSCIX[1][2].

Market Expansion and Commercial Strategy

Commercial Infrastructure Investments

scPharmaceuticals plans to strategically invest in commercial and sales infrastructure to capitalize on the growing acceptance of FUROSCIX. This includes measured investments to balance fiscal prudence with the need for aggressive market expansion[1][2].

Integrated Delivery Networks (IDNs) and Hospital Systems

The company has received direct purchases from 14 Integrated Delivery Networks (IDNs)/hospital systems year to date, indicating strong institutional support for the product[3].

Future Prospects

Price Increase and Revenue Impact

A 5.5% price increase of FUROSCIX at the end of September 2024 is expected to have a positive impact on product revenues, further contributing to the company's financial growth[3].

Lifecycle Management Initiatives

scPharmaceuticals continues to focus on lifecycle management initiatives, including the development of the FUROSCIX autoinjector and the expansion of indications. These efforts are aimed at maintaining and enhancing the product's market position[1][2].

Key Takeaways

• Growing Market Acceptance: Increasing prescribers and doses filled indicate strong market acceptance of FUROSCIX.
• Financial Growth: Net revenue has consistently increased, with significant improvements in gross-to-net discounts.
• Regulatory Milestones: FDA approvals and positive PK/PD data are crucial for future growth.
• Financing and Cash Position: Recent financing deals have extended the company's cash runway.
• Operational Costs: Increasing operational costs highlight the need for continued revenue growth.
• Commercial Strategy: Strategic investments in commercial infrastructure are key to market expansion.

FAQs

Q: What is the current market acceptance of FUROSCIX? A: The number of unique prescribers has increased by 24% to 2,713 by the end of Q2 2024, and doses filled have grown by 15% sequentially to 9,300 in Q2 2024[1][2].

Q: How has the revenue of FUROSCIX performed in recent quarters? A: Net FUROSCIX revenue increased by 33% sequentially to $8.1 million in Q2 2024 and further to $10.0 million in Q3 2024[1][2][3].

Q: What are the recent regulatory advancements for FUROSCIX? A: The FDA approved the expansion of the FUROSCIX indication to include NYHA Class IV chronic heart failure patients and accepted the sNDA for CKD patients[1][2].

Q: How has scPharmaceuticals financed its operations recently? A: The company completed financing deals totaling up to $175 million, including senior debt, synthetic royalty, and equity funding[1][2][3].

Q: What are the future prospects for FUROSCIX? A: The company expects continued growth driven by a price increase, lifecycle management initiatives, and strategic investments in commercial infrastructure[1][2][3].

Sources

1. Synapse: scPharmaceuticals Q2 2024 Financial Results and Business Update.
2. Stock Titan: scPharmaceuticals Inc. Reports Second Quarter 2024 Financial Results.
3. GlobeNewswire: scPharmaceuticals Inc. Reports Third Quarter 2024 Financial Results.
4. scPharmaceuticals Inc.: scPharmaceuticals Inc. Reports First Quarter 2024 Financial Results.
5. Stock Titan: scPharmaceuticals Inc. Reports First Quarter 2024 Financial Results.