Last updated: March 21, 2026
What is the Drug Associated with NDC 70842-0111?
NDC 70842-0111 corresponds to Prodazic (generic: fostamatinib disodium hexahydrate). It was approved by the FDA for treating adult patients with chronic immune thrombocytopenia (ITP). Fostamatinib inhibits spleen tyrosine kinase (SYK), reducing platelet destruction. The drug, marketed by Rigel Pharmaceuticals, gained approval in early 2018.
Market Landscape and Competitive Position
Indication and Market Size
Chronic ITP affects approximately 60,000 to 70,000 adults in the U.S. (AABB, 2021). The standard of care includes corticosteroids, splenectomy, thrombopoietin receptor agonists (e.g., eltrombopag, romiplostim), and immunosuppressants. Fostamatinib entered a market with established therapies but offers an oral, non-immunosuppressive option.
Key Competitors
| Drug |
Class |
Year Approved |
Indications |
Market Share (2023) |
| Eltrombopag (Promacta) |
Thrombopoietin receptor agonist |
2008 |
ITP |
55% |
| Romiplostim (Nplate) |
Thrombopoietin receptor agonist |
2008 |
ITP |
38% |
| Fostamatinib (Tavlesse) |
SYK inhibitor |
2018 |
ITP |
7% |
Note: Market share estimates based on IMS Health data as of late 2022.
Pricing and Reimbursement Context
Fostamatinib’s pricing has remained competitive with other ITP therapies. List price per 30-day supply averages approximately $9,800 (Source: GoodRx, 2023). Reimbursement policies favor oral therapies with less invasive administration, positioning fostamatinib favorably.
Price Projections
Current Pricing Dynamics
| Price Metric |
2022 |
2023 |
2024 (Projected) |
| Average wholesale price (AWP) per month |
$9,800 |
$9,800 |
$9,800 |
| Out-of-pocket (insured patients) |
$150–$350 (after insurance) |
Stable |
Slight decrease with insurance negotiations |
| Reimbursement rate |
Fixed |
Fixed |
Unlikely to change significantly |
Revenue Projections
Assuming steady adoption among 25% of the estimated 70,000 U.S. adult ITP patients, with 20% being treatment-naïve and 80% previously treated, the target market in 2023 could include 17,500 patients.
| Scenario |
Treatment Adoption |
Monthly Revenue |
Annual Revenue |
| Conservative |
10% patient uptake (1,750) |
$17.1M |
$205M |
| Moderate |
25% patient uptake (4,375) |
$42.8M |
$514M |
| Aggressive |
50% patient uptake (8,750) |
$85.4M |
$1.0B |
Factors Influencing Price and Market Share
- Market Penetration Strategy: Greater marketing efforts could increase uptake.
- Patent Status: Patents expire by 2028; biosimilar competition can reduce prices thereafter.
- Off-label Use: Expansion into other thrombocytopenic conditions might cause price adjustments.
- Regulatory Changes: Accelerated approval pathways or pricing regulations could impact prices.
Potential Price Adjustment Scenarios
| Scenario |
Impact |
Rationale |
| Price hold |
No change |
Established brand, current market position |
| Price reduction |
10–15% |
Competitive pressure, biosimilar entry post-2028 |
| Price increase |
5% |
In case of market monopoly or new indications |
Regulatory and Policy Considerations
- The drug remains under patent protection until 2028.
- Price increases are susceptible to Medicare negotiations and importation policies.
- The FDA continues to support differentiated therapies, potentially opening pathways for expanded approval.
Key Factors for Investment and R&D
- Market share growth potential depends on increased clinician awareness and expanded indications.
- Patent expiration risk circa 2028 necessitates pipeline development.
- Pricing flexibility is limited but can be influenced through payer negotiations and patient assistance programs.
Key Takeaways
- NDC 70842-0111 (fostamatinib) targets a niche market within chronic ITP, with limited but growing market share.
- The current price remains around $9,800 per month, with stable reimbursement prospects.
- revenue projections vary widely based on market penetration, from roughly $200 million to over $1 billion annually.
- Patent status influences future pricing and competitive dynamics, with biosimilars entering post-2028.
- Broader adoption depends on physician education, expanded indications, and competitive strategies.
FAQs
1. What factors could significantly affect the price of fostamatinib after 2023?
Patent expiration in 2028 could lead to biosimilar entry, pressuring prices downward. Reimbursement negotiations and policy changes also influence pricing.
2. How does fostamatinib’s market share compare to other ITP treatments?
It holds approximately 7% of the U.S. ITP market, considerably lower than thrombopoietin receptor agonists which control over 90% combined.
3. Are there ongoing trials to expand fostamatinib indications?
Yes, Phase 3 trials are evaluating fostamatinib for other autoimmune conditions, potentially broadening its market.
4. What are the main barriers to increasing fostamatinib’s market share?
Limited clinician awareness, competition from established therapies, and patent duration.
5. How does the drug pricing compare internationally?
Pricing varies; in Europe, prices are typically 20-30% lower due to negotiated discounts and healthcare policies.
References
[1] AABB. (2021). Overview of immune thrombocytopenia. Retrieved from https://aabb.org
[2] GoodRx. (2023). Fostamatinib (Tavlesse) Price. Retrieved from https://goodrx.com
[3] IMS Health. (2022). U.S. Market Share Data for ITP Treatments.
[4] FDA. (2018). Fostamatinib FDA approval letter.
[5] Rigel Pharmaceuticals. (2023). Fostamatinib product details.
