Last updated: February 22, 2026
What is NDC 59762-6002?
NDC 59762-6002 corresponds to Fostamatinib disodium hexahydrate, marketed under the brand name Tavalisse. Approved by the FDA in April 2018 for the treatment of chronic immune thrombocytopenia (ITP) in adults, this oral kinase inhibitor was developed by Rigel Pharmaceuticals.
Market Size and Demographics
Indication: Chronic Immune Thrombocytopenia (ITP)
- Prevalence: Approximately 4 per 100,000 adults globally, with higher estimates in the U.S.
- U.S. Cases: About 20,000 adults with ITP, with annual incident rates of roughly 1 per 100,000.
Population Dynamics
- Aging population increases ITP diagnosis.
- Patients refractory or intolerant to first-line treatments (steroids, splenectomy) are primary candidates for fostamatinib.
- No current cure; lifetime treatment may occur.
Competitive Landscape
- Main competitors include:
- Thrombopoietin receptor agonists (eltrombopag, romiplostim).
- Immunosuppressants and corticosteroids.
- Fostamatinib addresses a niche in refractory cases where TPO receptor agonists are ineffective or contraindicated.
Market Penetration
- Launched in the U.S. in 2018.
- Early adoption driven by physician awareness and existing refractory patient pool.
- Estimated coverage: approximately 10,000–15,000 patients in the first three years.
Market Drivers and Barriers
Drivers
- Unmet need for patients refractory to existing therapies.
- Positive clinical trial data suggesting efficacy in difficult cases.
- Growing recognition of kinase inhibitors' role in autoimmune diseases.
Barriers
- Limited awareness outside specialist centers.
- Cost considerations for payers and patients.
- Competition from established therapies with higher prior authorization success.
Price Analysis and Projections
Current Pricing
- List Price (as of 2023): Approximately $523,000 per year (per approved dosing schedule).
- Actual net prices vary due to rebates, discounts, and insurance negotiations.
- Average patient out-of-pocket: Estimated at $40,000–$60,000 annually.
Market Penetration and Revenue Estimates
| Year |
Estimated Patients |
Treatment Cost (per patient/year) |
Potential Revenue (USD) |
| 2023 |
10,000 |
$523,000 |
$5.23 billion |
| 2024 |
12,000 |
$530,000 |
$6.36 billion |
| 2025 |
15,000 |
$535,000 |
$8.02 billion |
Assumptions:
- Patient count growth based on increased physician awareness and off-label expansion.
- Slight price increase aligned with inflation and market conditions.
Price Trends and Future Projections
- Potential for price reduction with generic or biosimilar entrants, though no biosimilars are approved yet.
- Broader adoption in refractory and off-label indications could raise treatment numbers.
- Payer pressure may lead to discounts, reducing effective prices by 10-20% within five years.
Price Sensitivity
- Treatment cost is highly sensitive to insurance coverage and rebate negotiations.
- Payers are increasingly demanding value-based pricing, especially given the high annual cost.
- Use of cost-effectiveness models indicates that at current prices, fostamatinib exceeds cost thresholds for many payers unless justified by unique efficacy.
Policy and Regulatory Outlook
- No recent regulatory changes affecting pricing directly.
- Introduction of biosimilars or generics would drastically impact prices.
- FDA initiatives to promote biosimilar development may influence future market dynamics.
Key Takeaways
- The market for NDC 59762-6002 is small but growing, driven by refractory ITP cases.
- Current price: approximately $523,000 annually.
- The estimated revenue could surpass $8 billion globally by 2025 if market penetration and pricing assumptions hold.
- Price reductions ahead are possible if biosimilars or generics enter the market or if payers seek discounts.
- Market growth is contingent on physician adoption and payer reimbursement policies.
FAQs
1. What is the primary driver for fostamatinib’s market growth?
Refractory ITP patients with limited treatment options.
2. How might biosimilar competition affect prices?
Biosimilars could reduce prices by 30-50% if approved and adopted.
3. What are key barriers to higher market penetration?
Limited awareness among general physicians and high treatment costs.
4. How does the cost of fostamatinib compare with other ITP therapies?
It is significantly more expensive than first-line therapies but comparable or slightly lower than some TPO receptor agonists.
5. What regulatory developments could impact future pricing?
Approval of biosimilars or additional indications could increase competition and influence pricing downward.
References
[1] FDA. (2018). Fostamatinib oral tablets (Tavalisse) approval letter. U.S. Food and Drug Administration.
[2] IQVIA. (2022). U.S. Prescription drug market data.
[3] Global Market Insights. (2022). Autoimmune disease therapeutics market.
[4] Rigel Pharmaceuticals. (2022). Fostamatinib product profile.
