Sparsentan - Generic Drug Details

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

Sparsentan is the generic ingredient in one branded drug marketed by Travere and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Sparsentan has twenty-nine patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for sparsentan

International Patents:	29
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	8
Patent Applications:	139
What excipients (inactive ingredients) are in sparsentan?	sparsentan excipients list
DailyMed Link:	sparsentan at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sparsentan

Constraining patent/regulatory exclusivity:

TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON FEBRUARY 17, 2023

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for sparsentan

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

Sponsor	Phase
University of Edinburgh	Phase 2
University of Leicester	Phase 2
Travere Therapeutics, Inc.	Phase 1

See all sparsentan clinical trials

Pharmacology for sparsentan

Drug Class	Angiotensin 2 Receptor Blocker Endothelin Receptor Antagonist
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Endothelin Receptor Antagonists P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sparsentan

C09XX	Other agents acting on the renin-angiotensin system
C09X	OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for sparsentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No

International Patents for sparsentan

Country	Patent Number	Title	Estimated Expiration
Slovenia	2732818
Poland	3222277
Cyprus	1119232

Market Dynamics and Financial Trajectory for Sparsentan (FILSPARI)

Introduction to Sparsentan (FILSPARI)

Sparsentan, marketed as FILSPARI, is a groundbreaking drug developed by Travere Therapeutics for the treatment of primary immunoglobulin A nephropathy (IgAN) and potentially other rare kidney diseases. Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical advancement.

Regulatory Approvals and Designations

Sparsentan has garnered significant regulatory milestones. In September 2024, it received full FDA approval for slowing kidney function decline in adults with IgAN, marking it as the only non-immunosuppressive treatment for this condition[2][5].

In Japan, sparsentan was granted Orphan Drug Designation, which is expected to expedite its development and approval process in the region. Renalys Pharma holds the exclusive license for its development and commercialization in several Asian countries[1].

Clinical Efficacy and Trials

The clinical efficacy of sparsentan has been demonstrated through various trials. The PROTECT study, a global phase III trial, provided pivotal data supporting its approval for IgAN. However, in the case of focal segmental glomerulosclerosis (FSGS), the DUPLEX study showed that while sparsentan did not meet the primary endpoint of significantly improving kidney function, it did exhibit favorable trends in secondary efficacy metrics and a good tolerability profile[4].

Market Acceptance and Sales Performance

Since its launch, FILSPARI has shown robust market acceptance. In the third quarter of 2024, net product sales of FILSPARI totaled $35.6 million, representing a significant increase from the previous quarter. The drug has seen continuous growth, with 505 new patient start forms (PSFs) received during this period, bringing the total to 2,484 PSFs since its launch[2][5].

The commercial performance of FILSPARI has been exceptional, with the third quarter of 2024 marking the highest sales to date. This growth is attributed to the drug's unique position as the first non-immunosuppressive treatment for IgAN, replacing the current standard of care[2].

Financial Performance of Travere Therapeutics

Travere Therapeutics has reported strong financial results driven by the success of FILSPARI. For the third quarter of 2024, total revenue was $62.9 million, with net product sales of $61.0 million. This includes $35.6 million from FILSPARI sales alone, indicating a substantial contribution to the company's revenue[2].

Revenue Breakdown

• Net Product Sales: FILSPARI sales have been the primary driver of revenue growth, with $35.6 million in the third quarter of 2024.
• Total Revenue: The company's total revenue for the third quarter was $62.9 million, including $1.9 million from license and collaboration revenue[2].

Expenses and Net Loss

While the revenue has been impressive, Travere Therapeutics also incurs significant expenses related to research and development (R&D), selling, general, and administrative (SG&A) activities. Despite these expenses, the company's financial position remains strong, with cash, cash equivalents, and marketable securities totaling $325.4 million as of June 30, 2024[5].

Risks and Challenges

Despite the positive trajectory, there are several risks and challenges associated with the commercial launch and development of FILSPARI. These include market acceptance, efficacy, safety, price, reimbursement, and competition from other therapies. Additionally, there are risks related to manufacturing scale-up and the successful execution of commercial strategies[2][3].

Future Outlook and Potential Indications

Travere Therapeutics is exploring additional regulatory paths for sparsentan, particularly for FSGS. Although the DUPLEX study did not meet its primary endpoint, the company is encouraged by the favorable trends in secondary efficacy metrics and is engaging with regulators to determine a potential path for approval in FSGS[4].

Global Expansion

Renalys Pharma's exclusive license for sparsentan in several Asian countries positions the drug for significant global expansion. The Orphan Drug Designation in Japan further accelerates this process, indicating a promising future for the drug's international market presence[1].

Key Takeaways

• Regulatory Approvals: Full FDA approval for IgAN and Orphan Drug Designation in Japan.
• Clinical Efficacy: Proven efficacy in IgAN, with ongoing efforts for FSGS.
• Market Acceptance: Strong sales performance and continuous growth in PSFs.
• Financial Performance: Significant revenue growth driven by FILSPARI sales.
• Risks and Challenges: Market acceptance, manufacturing, and regulatory risks.
• Future Outlook: Potential expansion into FSGS and global markets.

FAQs

Q: What is the primary indication for sparsentan (FILSPARI)?

A: Sparsentan (FILSPARI) is primarily indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Q: Has sparsentan received any special designations?

A: Yes, sparsentan has received full FDA approval and Orphan Drug Designation in Japan for IgAN.

Q: What are the financial highlights of FILSPARI's sales performance?

A: In the third quarter of 2024, net product sales of FILSPARI totaled $35.6 million, with 505 new patient start forms received during the period.

Q: What are the potential future indications for sparsentan?

A: Travere Therapeutics is exploring regulatory paths for sparsentan in the treatment of focal segmental glomerulosclerosis (FSGS).

Q: Who holds the exclusive license for sparsentan in Asia?

A: Renalys Pharma holds the exclusive license for the development and commercialization of sparsentan in several Asian countries.

Sources:

1. PR Newswire: "Sparsentan receives Orphan Drug Designation for primary IgA nephropathy in Japan"
2. Travere Therapeutics: "Travere Therapeutics Reports Third Quarter 2024 Financial Results"
3. BioSpace: "Travere Therapeutics Presents Data Reinforcing Clinical Benefit of FILSPARI (sparsentan) in IgAN and Late-Breaking Presentation in FSGS at ASN Kidney Week 2024"
4. BioSpace: "Travere's Sparsentan Stumbles in Phase III Rare Kidney Disease Pivotal Study"
5. Travere Therapeutics: "Travere Therapeutics Reports Second Quarter 2024 Financial Results"

Last updated: 2024-12-16