Last updated: March 9, 2026
What is the Drug Associated with NDC 67877-0749?
NDC 67877-0749 corresponds to Sparsentan, marketed under the brand REMSI (generic: Sparsentan). It is a dual endothelin receptor antagonist approved by the FDA in November 2021 for treating Focal Segmental Glomerulosclerosis (FSGS) in adults. PGX data indicates Spike in demand following FDA approval, with recognized potential for unmet needs in FSGS therapy.
Market Size and Therapeutic Landscape
Estimated Patient Population
- Prevalence of FSGS: 1.5–1.8 per 100,000 persons globally.
- U.S. Prevalence: Approximately 7,500–9,000 patients based on current epidemiological data [1].
- Treatment-Eligible Population: Patients with persistent proteinuria despite standard therapy.
Competitive Environment
- Existing Therapies: Corticosteroids, calcineurin inhibitors, and newer agents like sparsentan introduce targeted options.
- Market Gap: No FDA-approved drugs specifically for FSGS since the approval of immunosuppressants, creating substantial unmet needs.
Launch Impact
- First FDA-approved drug with specific indication for FSGS.
- Anticipated rapid adoption due to unmet need and clinical trial data demonstrating efficacy.
Price Analysis
Current Pricing Strategy
- List Price: Estimated at approximately $12,000 to $15,000 per month based on comparable orphan drugs.
- Annual Cost: $144,000 to $180,000 per patient.
- Insurance Coverage: Typically covers specialty drugs with copays ranging from $50 to $200 per month, subject to plan specifics.
Pricing Benchmarks
| Drug |
Indication |
Monthly Price |
Annual Price |
Market Position |
| Sparsentan (REMSI) |
FSGS |
$12,000–$15,000 |
$144,000–$180,000 |
First targeted therapy approved for FSGS |
| Rituximab |
FSGS (off-label) |
~$7,000 |
~$84,000 |
High cost, off-label use |
| Cyclosporine / Tacrolimus |
FSGS (off-label) |
$2,000–$4,000 |
$24,000–$48,000 |
Less specific, variable efficacy |
Cost Projections
- Initial Year: Approximate total U.S. treatment cost ranges from $150M to $200M, assuming conservative uptake of 1,000 patients in the first year.
- Growth Trajectory: As awareness and prescribing increase, projections estimate a compound annual growth rate (CAGR) of 10-15% over five years.
- Market Penetration: Estimated to reach 25-30% of eligible patients within 3 years post-launch.
Market Drivers
- Regulatory Approval: Confirmed efficacy and safety profile.
- Unmet Needs: Limited alternatives for FSGS patients resistant to other therapies.
- Pricing Leverage: Orphan drug status allows for premium pricing.
- Physician Adoption: Based on clinical guidelines and early prescriber protocols.
Market Challenges
- Reimbursement: High-cost drugs may face payer resistance.
- Adherence: Chronic therapy requiring sustained compliance.
- Competition: Potential future approvals of similar agents or biosimilars.
Price Projection Scenarios
| Scenario |
Year 1 |
Year 3 |
Year 5 |
Assumptions |
| Conservative |
$144M |
$200M |
$250M |
10% market share, slow uptake |
| Moderate |
$180M |
$350M |
$500M |
20% market share, increasing prescriber familiarity |
| Aggressive |
$250M |
$600M |
$800M |
30–40% market share, high physician adoption |
Key Takeaways
- NDC 67877-0749 (Sparsentan) positions as a first-in-class therapy for FSGS.
- Pricing is expected in the $12,000–$15,000/month range, reflecting orphan drug premium.
- The total addressable market could reach $200–$800 million over five years, depending on uptake.
- Market growth hinges on reimbursement, clinical acceptance, and competitive responses.
FAQs
Q1: How does Sparsentan compare to existing FSGS treatments?
It offers targeted dual endothelin receptor antagonism, providing potentially superior efficacy for resistant cases, unlike broader immunosuppressants.
Q2: What factors influence pricing strategy?
Orphan drug designation allows premium pricing; clinical efficacy, patent protection, and reimbursement policies guide final pricing.
Q3: What is the anticipated timeline for market penetration?
Full adoption could occur within 3–5 years, contingent on payer acceptance and prescriber familiarity.
Q4: Are there significant regional pricing differences?
Yes; US pricing is typically higher due to payer dynamics, with potential discounts and rebates influencing net pricing globally.
Q5: What are the main barriers to market growth?
Reimbursement hurdles, high cost, competition from off-label therapies, and low disease awareness.
References
[1] Kadashevich, E., et al. (2022). Epidemiology of Focal Segmental Glomerulosclerosis: A Systematic Review. Kidney International Reports, 7(4), 861–878.
