Last updated: February 14, 2026
Summary:
NDC 42291-0525 is the drug Sparsentan (brand name: Filspari), marketed by Travere Therapeutics. It is indicated for treatment of focal segmental glomerulosclerosis (FSGS) and primary portal hypertension. Sparsentan entered the market in late 2022 following FDA approval in August 2022. Market dynamics are influenced by competition, pricing, and adoption rates, with projections indicating steady growth over the next five years.
What is the Current Market Landscape for Sparsentan?
Market Entry and Indications:
- FDA approved in August 2022 for FSGS and primary portal hypertension.
- Approved indication is rare, targeting a small patient population.
- Launched in late 2022.
Market Size and Demand Drivers:
- FSGS prevalence: approximately 7-15 per 100,000 in the US ([1]).
- Estimated US patient population for FSGS: approximately 20,000–30,000.
- Limited competition; the primary alternative is off-label use of corticosteroids or immunosuppressants.
- No direct branded competitors; similar drugs include endothelin receptor antagonists used off-label.
Pricing and Reimbursement:
- List price at launch: roughly $3,000 per month for a typical dose.
- Payer negotiations are still evolving, with insurance coverage increasingly favorable.
- Out-of-pocket costs may vary based on insurance policy, with copays potentially in the $100-$400 range.
Market Penetration Factors:
- Early adoption in specialty centers.
- Physician familiarity impacting initial prescribing behavior.
- Patient acceptance influenced by side-effect profile and administration route.
How Is the Pricing for Sparsentan Expected to Evolve?
Price Trends Since Launch:
- Initial list price: $3,095/month in late 2022.
- Actual reimbursed price may be lower due to discounts and negotiations.
- No recent substantial price reductions observed, but some payers may negotiate rebates.
Factors Influencing Price Changes:
- Increased competition: Upcoming drugs in similar spaces could apply downward pressure.
- Expanded indications: If Sparsentan gains approval for additional uses, volume could increase, influencing pricing strategies.
- Cost-containment efforts by payers: Tighter formularies and step therapy could restrict early access, impacting revenue.
| Projections for 2023–2028: |
Year |
Estimated Average Monthly Price |
Notes |
| 2023 |
~$3,000 |
Stable; inflation adjustment possible. |
| 2024 |
~$2,950–$3,100 |
Slight variations due to negotiation and rebates. |
| 2025 |
~$2,900–$3,050 |
Possible downward trend with increased competition. |
| 2026 |
~$2,850–$3,000 |
Market stabilization expected; generic entry unlikely. |
| 2027–2028 |
~$2,800–$2,950 |
Price plateau; volume growth critical to revenue. |
What Are the Key Revenue and Market Share Projections?
Revenue Projections (US Market):
- 2023: ~$72 million (assuming 2,400 patients on therapy).
- 2024: ~$85 million (assuming 2,800 patients).
- 2025: ~$100 million (3,300 patients with increasing adoption).
- 2026: ~$115 million.
- 2027–2028: Growth stabilizes around $130 million.
Market Share Considerations:
- Early market share: approximately 20–30%.
- Penetration rate expected increase to 50%+ over five years with expanded indications and awareness campaigns.
- Off-label competitors may limit maximum market share.
What Are the Key Risks to Market and Price Growth?
- Regulatory: Delays or denials for expanded indications.
- Competitive: Launch of oral alternatives or other mechanisms for FSGS.
- Pricing: Payer pushback limiting reimbursement levels.
- Clinical: Safety signals or side effects reducing prescriber confidence.
Market expansion depends heavily on demonstrating clinical efficacy and favorable safety profile, influencing whether reimbursement levels sustain current prices.
Key Takeaways:
- NDC 42291-0525 (Sparsentan) launched in 2022 targeting a niche, rare disease market.
- Initial pricing around $3,000/month is expected to remain stable in the near term.
- Market growth relies on increased adoption, expanding indications, and payer acceptance.
- Projections suggest revenues of approximately $85–$100 million in the US by 2024–2025.
- Risks include competitive pressure and payer policies that could compress prices.
FAQs
Q1: What is the primary driver of Sparsentan's market valuation?
Patient population size for FSGS, drug efficacy, and physician uptake.
Q2: How does Sparsentan compare to existing treatments?
It offers a targeted mechanism specific to FSGS, with the potential for better efficacy and fewer side effects than off-label immunosuppressants.
Q3: What price discounts or rebates are common post-launch?
Negotiated rebates vary but often reduce net price by 10–30% based on payer size and formulary agreements.
Q4: Will expanding indications impact the price?
Yes; approval for additional indications can increase volume and may lead to price adjustments depending on value propositions.
Q5: How does the potential generic entry impact pricing?
Since Sparsentan’s patent life extends beyond 2030, generic entry is unlikely within the forecast period.
References
[1] National Kidney Foundation. "Focal segmental glomerulosclerosis (FSGS)." Accessed December 2022.
