Sparsentan - Generic Drug Details

What are the generic sources for sparsentan and what is the scope of patent protection?

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:	10
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
Brigham and Women's Hospital	PHASE1
Travere Therapeutics, Inc.	PHASE1
Travere Therapeutics, Inc.	PHASE4

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	216403-002	Feb 17, 2023		RX	Yes	Yes
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No	9,993,461
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-002	Feb 17, 2023		RX	Yes	Yes
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	216403-002	Feb 17, 2023		RX	Yes	Yes	9,993,461
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-002	Feb 17, 2023		RX	Yes	Yes

International Patents for sparsentan

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3708163	UTILISATION DE SPARSENTAN POUR LE TRAITEMENT DES MALADIES INFLAMMATOIRES CHRONIQUES (USE OF SPARSENTAN FOR THE TREATMENT OF CHRONIC INFLAMMATORY DISEASES)
Spain	2811342
Lithuania	2732818
European Patent Office	3222277	ANTAGONISTE DES RÉCEPTEURS DE L'ENDOTHÉLINE ET DE L'ANGIOTENSINE II À BASE DE BIPHÉNYLSULFONAMIDE POUR TRAITER LA GLOMÉRULOSCLÉROSE ET LA NEPHROPATHIE INDUITE PAR L'IGA (A BIPHENYLSULFONAMIDE ENDOTHELIN AND ANGIOTENSIN II RECEPTOR ANTAGONIST TO TREAT GLOMERULOSCLEROSIS AND IGA-INDUCED NEPHROPATHY)
Poland	2732818
China	102421434	Oral formulations of diphenylsulfonamide endothelin and angiotensin ii receptor agonists to treat elevated blood pressure and diabetic nephropathy
Lithuania	3222277

Market Dynamics and Financial Trajectory for Sparsentan

Last updated: July 28, 2025

Introduction

Sparsentan, a dual endothelin and angiotensin receptor antagonist developed by Travere Therapeutics, is positioned in a niche market targeting rare renal diseases, primarily focal segmental glomerulosclerosis (FSGS) and immunoglobulin A nephropathy (IgAN). As an investigational drug seeking regulatory approval, sparsentan’s commercial success hinges on evolving market dynamics, competitive positioning, regulatory pathways, and broader healthcare trends. This report analyzes the key factors shaping sparsentan’s market prospects and projects its financial trajectory over the coming years.

Market Landscape and Unmet Needs

Chronic kidney diseases (CKD), especially rare forms like FSGS and IgAN, lack targeted, approved therapies, creating a significant unmet medical need. FSGS affects approximately 7 to 16 per million individuals globally, with limited effective treatments available. Current management strategies primarily involve corticosteroids and immunosuppressants, which pose considerable adverse effects and variable efficacy.

The absence of licensed, disease-specific therapies provides a lucrative opportunity for sparsentan once approved. The drug's unique dual mechanism aims to address the pathogenic pathways more comprehensively, potentially positioning it as a first-in-class agent.

Regulatory Milestones and Pathway

Sparsentan has obtained Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for FSGS, expediting its review process. The pivotal Phase 3 PROTECT trial demonstrated significant reductions in proteinuria—a surrogate marker correlating with disease progression—in both FSGS and IgAN patients.

Pending FDA approval anticipated in mid-2023, sparsentan could enter the market as early as late 2023 or early 2024. The European Medicines Agency (EMA) has also granted orphan designation, which may facilitate a smoother approval process and market access in Europe. These regulatory milestones are critical drivers of the financial outlook.

Market Dynamics and Competitive Environment

1. Competitive Landscape
Currently, no approved targeted therapies specifically address FSGS or IgAN, rendering sparsentan potentially first-to-market. Competing drugs include off-label use of immunosuppressants and supportive treatments, with no direct pharmacologic competitors in the early stages.

2. Rapid Expansion of Rare Disease Therapeutics
The orphan drug market is expanding at a compound annual growth rate (CAGR) of approximately 10-15%, driven by favorable regulatory incentives, pricing, and increasing recognition of rare disease burdens. Sparsentan’s orphan designation positions it advantageously within this ecosystem, likely ensuring market exclusivity for 7-12 years post-approval depending on jurisdiction.

3. Market Penetration Factors
Physician adoption depends on clinical efficacy, safety profile, and reimbursement landscape. The preliminary data suggests favorable outcomes, but real-world evidence will be vital. Additionally, the high unmet need and lack of alternatives favor early adoption.

4. Pricing Strategies
Pricing for rare disease drugs often ranges from $150,000 to $300,000 per patient annually, reflecting the therapeutic value and cost burden of untreated disease. As sparsentan is expected to be used chronically, its pricing will significantly influence revenue projections.

Financial Projections

1. Revenue Forecasting
Assuming approval by late 2023, initial sales will likely target a niche patient population—estimated at 2,000-3,000 patients in the U.S. alone for FSGS—expanding as evidence accumulates.

• Year 1 (2024):

  • Approximate patient uptake: 10-15% of eligible patients (200-450).
  • Average price per patient: $200,000.
  • Estimated revenue: $40-90 million.

• Year 2 (2025):

  • Increased penetration: 30-50%.
  • Revenue: $150-300 million.

• Year 3 and beyond (2026+):

  • Market expansion into Europe and other regions (additional 50-70% of U.S. base).
  • Longer-term growth driven by label expansion to related conditions.

2. Cost Considerations
R&D costs for further clinical trials, post-marketing surveillance, and manufacturing will influence profit margins. Travere’s previously reported R&D expenses for sparsentan suggest high early investment, but economies of scale and increased sales volumes are expected to improve margins over time.

3. Licensing, Partnerships, and Market Access
Partnership agreements with regional distributors or global pharma players could accelerate market penetration, sharing commercialization costs and mitigating risks. Also, reimbursement negotiations will be critical in achieving premium pricing and sustainable revenue streams.

Challenges and Risks

• Regulatory Uncertainty: Delay or rejection could significantly impact financial trajectory. Post-approval safety concerns may also influence market adoption.
• Market Adoption: Physicians’ acceptance hinges on long-term efficacy and safety data, which continues to accrue.
• Pricing and Reimbursement: Payer resistance to high-cost therapies could limit accessible patient populations.
• Competition Development: The landscape could evolve, with alternative therapies or generics emerging in this space.

Long-term Financial Outlook

With a successful regulatory outcome, sparsentan’s market entry could generate peak annual sales exceeding $500 million within 5 years, considering global expansion and label broadening. Given the high unmet need, the favorable regulatory environment, and a growing orphan drug market, sparsentan's commercial trajectory appears promising.

However, sustained growth depends on clinical validation, payor acceptance, and strategic marketing. The company's ability to maintain exclusivity and optimize pricing will be decisive in maximizing shareholder value.

Key Takeaways

• Market Opportunity: Sparsentan addresses a critical unmet need in rare renal diseases with no targeted therapies, providing a differentiated position in nephrology.

• Regulatory Catalysts: Approval from FDA—expected in late 2023—will be a pivotal event unlocking commercial potential.

• Revenue Potential: Estimated to reach hundreds of millions annually within 3-5 years post-approval, contingent on patient access, pricing, and market penetration strategies.

• Competitive Advantages: Orphan designation, first-mover advantage, and demonstrable efficacy strengthen sparsentan’s market position.

• Investment Considerations: Risks include regulatory delays, market acceptance, and pricing challenges; however, favorable clinical data and market dynamics support a positive financial outlook.

FAQs

1. What is the current regulatory status of sparsentan?
Sparsentan is under review by the FDA with a potential approval date anticipated in late 2023. It has received orphan and breakthrough therapy designations, facilitating a streamlined review process.

2. How does sparsentan compare to existing therapies?
Currently, no targeted therapies for FSGS or IgAN exist. Sparsentan's dual mechanism offers a novel approach, with early clinical data indicating significant reductions in proteinuria, a surrogate marker linked to disease progression.

3. What are the primary factors influencing sparsentan’s market success?
Regulatory approval, clinical efficacy, safety profile, physician adoption, pricing strategy, and reimbursement policies are key determinants.

4. What is the projected revenue for sparsentan in the next five years?
Assuming favorable approval and market conditions, peak annual revenues could surpass $500 million, with significant growth expected as indications and regions expand.

5. What risks could impact sparsentan's commercial outlook?
Regulatory setbacks, safety concerns, payer resistance, high development costs, or emergence of competing therapies could hinder its market penetration.

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Sources

1. Travere Therapeutics. Sparsentan Clinical Development Update
2. FDA Breakthrough Therapy Designations
3. Global Orphan Drug Market Analysis
4. Clinical trial data for sparsentan (PROTECT trial)
5. Pricing and reimbursement trends in rare disease therapeutics

Note: Citations are illustrative; actual references should be sourced from regulatory filings, clinical trial reports, and market research data.