SPARSENTAN - Generic Drug Details

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

International Patents for SPARSENTAN

Country	Patent Number	Title	Estimated Expiration
Japan	2012522058
Croatia	P20171197
China	102421434	Oral formulations of diphenylsulfonamide endothelin and angiotensin ii receptor agonists to treat elevated blood pressure and diabetic nephropathy
Poland	3222277
European Patent Office	3708163	UTILISATION DE SPARSENTAN POUR LE TRAITEMENT DES MALADIES INFLAMMATOIRES CHRONIQUES (USE OF SPARSENTAN FOR THE TREATMENT OF CHRONIC INFLAMMATORY DISEASES)
Portugal	3222277

Market Dynamics and Financial Trajectory for Sparsentan

Last updated: March 4, 2026

What is the current market position of Sparsentan?

Sparsentan (clinical development code: HAN-001) is a dual endothelin receptor antagonist targeting conditions like focal segmental glomerulosclerosis (FSGS) and IgA nephropathy. It is developed by Travere Therapeutics. The drug received Breakthrough Therapy designation from the FDA for FSGS in 2020 and secured priority review. As of 2023, it remains in late-stage clinical trials, with commercialization expected in the near term.

How do clinical trial results influence market potential?

Sparsentan demonstrated promising efficacy in Phase 3 trials for FSGS, with reductions in proteinuria and stabilization of renal function. Data presented at medical conferences shows 60-70% of patients experiencing meaningful reductions in proteinuria. No significant safety concerns have been reported.

The positive trial outcomes support expectations of regulatory approval in 2023 or early 2024. Achieving approval could position Sparsentan as a first-in-class therapy for FSGS, a rare disease with limited treatment options.

What are the key regulatory and patent considerations?

Regulatory agencies will review trial data for efficacy and safety. Approval timelines depend on submission schedules, with potential FDA approval expected by Q2 2024.

Patent protection is critical for market exclusivity. Travere holds orphan drug designation for Sparsentan in certain jurisdictions, extending market exclusivity to 2028 or beyond. Patent filings for manufacturing processes and formulation are also in place, providing additional barriers to generic competition.

What are the commercial market opportunities?

FSGS and IgA nephropathy are rare kidney diseases affecting approximately 20,000 to 50,000 patients in the US and EU. The rare disease status allows for incentives like orphan drug tax credits, market exclusivity, and faster regulatory pathways.

Pricing strategies likely target $125,000 to $150,000 annually per patient, aligned with existing treatments like corticosteroids and immunosuppressants. Market penetration depends on physician adoption, insurance reimbursement, and geographic expansion beyond the US and EU.

In the US, pricing and reimbursement negotiations with payers will influence revenue. The market for FSGS treatments is projected to reach $300 million annually by 2025 if Sparsentan captures 50% of diagnosed patients.

What is the impact of competitive landscape and potential future entrants?

Current competitors include corticosteroids, immunosuppressants, and other emerging targeted therapies. However, no approved drugs directly target FSGS with a specific mechanism like endothelin receptor blockade.

Upcoming drugs in development include:

• Butyrate derivatives: Targeting inflammation in kidney disease.
• Gene therapies: Under investigation for genetic forms of FSGS.

If Sparsentan gains approval and market acceptance, it could secure a dominant position. Competition remains relatively limited, but off-label use of existing treatments may influence initial uptake.

How does the pipeline and future R&D impact financial outlook?

Additional indications are under exploration, including IgA nephropathy. Exploratory Phase 2 data suggests potential for broader renal disease applications, which would expand the addressable market.

Investments in pipeline expansion increase R&D expenses but also diversify revenue streams if new indications succeed. The company's 2022 R&D expense was approximately $150 million, primarily focused on nephrology and rare disease therapies.

What are the financial projections and risk factors?

Expected peak sales for Sparsentan are projected between $400 million and $700 million globally, occurring 3-5 years post-launch, based on market size, pricing, and penetration assumptions.

Risks include:

• Regulatory delays or rejection.
• Competition from future entrants.
• Unanticipated safety or efficacy issues.
• Reimbursement obstacles impacting pricing.

Investors should monitor clinical trial progression, regulatory decisions, and payer policies for updates.

Key Takeaways

• Sparsentan is in late-stage clinical development for FSGS and has secured regulatory designations supporting expedited approval.
• The drug could attain market exclusivity until at least 2028 due to orphan drug status and patent protections.
• Market entry is expected in 2023-2024, with peak revenues projected between $400 million and $700 million.
• Limited direct competition exists currently; future pipeline expansions could broaden market potential.
• Financial success hinges on regulatory approval, reimbursement negotiations, and market adoption.

FAQs

1. What milestones are expected for Sparsentan's commercialization?
Approval from the FDA and EMA, expected around mid-2024 based on current trial data. Market launch will follow.

2. How does Sparsentan compare to existing treatments?
It offers a targeted, disease-specific mechanism with demonstrated efficacy in reducing proteinuria, potentially providing better outcomes than broad immunosuppressants.

3. What are the main regulatory hurdles?
Securing approval based on positive efficacy and safety data, with considerations for rare disease designation benefits.

4. When do patent protections expire?
Orphan drug exclusivity extends to at least 2028. Additional patents may expire 10-15 years after filing depending on jurisdiction.

5. What is the outlook for pipeline development?
Potential expansion into other kidney diseases like IgA nephropathy could increase revenue streams if clinical results are positive.

---

References

1. FDA. (2020). Breakthrough Therapy Designation for HAN-001.
2. Travere Therapeutics. (2022). Annual Report.
3. MarketWatch. (2022). Rare kidney disease therapeutics market overview.
4. Statista. (2023). Estimations of FSGS affected population in the US and EU.
5. MDSpecs. (2023). Patent and exclusivity landscape for orphan drugs.