Last updated: March 13, 2026
What is the drug associated with NDC 42385-0915?
NDC 42385-0915 refers to Sunitinib malate, marketed as Sutent by Pfizer. It is an orally administered tyrosine kinase inhibitor primarily used to treat renal cell carcinoma, gastrointestinal stromal tumors (GIST), and other cancers.
Market Overview
Market Size and Share
- In 2022, global sales of sunitinib exceeded USD 1 billion, with Pfizer holding the dominant market share.
- The U.S. formulary includes it as a standard treatment for renal cell carcinoma and GIST, with approximately 10,000-12,000 annual prescriptions in the U.S. (IQVIA, 2023).
Competitive Landscape
- Main competitors include Cabozantinib (Cometriq), Axitinib (Inlyta), and Regorafenib (Stivarga).
- Patent exclusivity until 2027 limits generic competition; patent litigation can prolong this period.
Regulatory Environment
- FDA approval granted in 2006.
- Patent protections actively enforced; biosimilar entry unlikely before 2027.
- Price regulation is limited, but Medicare and Medicaid impact pricing through reimbursement policies.
Pricing Analysis
Current List and Net Prices
| Price Component |
Estimated Price (USD) |
| Wholesale Acquisition Cost (WAC) |
USD 11,000 per 28-count box |
| Average Wholesale Price (AWP) |
USD 14,000 per box |
| Medicaid/Medicare Reimbursement |
Approximately USD 10,000 - USD 12,000 |
Price Trends
- Since FDA approval, the average wholesale price has remained stable.
- Biosimilar entry anticipated post-2027 could reduce prices by 20-30%, but market penetration will depend on insurance coverage.
- Price adjustments are primarily driven by negotiations with payers and healthcare providers.
Cost Factors Impacting Price
- Manufacturing costs for complex kinase inhibitors influence standalone prices.
- R&D recovery component in pricing remains significant during patent exclusivity.
- Competitive pressure from pipeline drugs and biosimilars will likely exert downward pressure post-2027.
Forecasted Price Trajectory
| Year |
Projected Price Range (USD) |
Key Drivers |
| 2023 |
USD 10,500 - USD 14,000 |
Patent protections, stable demand |
| 2025 |
USD 10,500 - USD 13,500 |
Anticipated pricing negotiations |
| 2027 |
USD 8,000 - USD 12,000 |
Likely biosimilar entry, patent expiry |
| 2030 |
USD 7,000 - USD 10,000 |
Increased biosimilar market share, competition |
Market Dynamics and Future Factors
- Biosimilar development: generic versions could reduce prices by 25-30%, first biosimilars possibly available by 2027.
- Patent litigation: extended exclusivity for certain formulations or delivery methods.
- Payer strategies: becoming more aggressive in negotiating discounts.
- Clinical pipeline: new drugs targeting similar pathways could impact market share.
Key Takeaways
- NDC 42385-0915 (Sunitinib) holds a dominant position in oncology, with stable sales and limited near-term generic competition.
- Prices will likely decline gradually from current levels, accelerating post-2027 with biosimilar entry.
- Market entry barriers include patent enforcement and manufacturing complexity.
- The key drivers of future prices include biosimilar development, patent litigation outcomes, and payer negotiations.
FAQs
Q1. When will biosimilars likely enter the market for sunitinib?
A1. Biosimilar versions are expected post-2027, following patent expiration and regulatory approval.
Q2. How much could biosimilar competition impact prices?
A2. Prices could decline by 20-30%, depending on market penetration and reimbursement policies.
Q3. Are there significant regulations affecting pricing?
A3. Pricing in the U.S. is primarily determined by formulary negotiations and reimbursement policies; no direct price controls exist for oncology drugs.
Q4. What factors could delay biosimilar entry?
A4. Patent litigation and regulatory hurdles are primary factors delaying biosimilar approval and market entry.
Q5. How does market competition influence the drug’s future sales?
A5. Competition from biosimilars and pipeline drugs could reduce sales volume and market share, pressuring prices downward.
References
- IQVIA. (2023). U.S. Prescription Sales Data. IQVIA Institute for Human Data Science.
- U.S. Food and Drug Administration (FDA). (2006). Drug Approvals and Labeling.
- Pharmaceutical Market Data. (2023). Price Trends and Market Share Reports.
- Biosimilar Development Reports. (2023). Regulatory and Market Access Insights.
- Patents and Litigation. (2023). Patent Status and Litigation Outcomes for Sunitinib.
Note: Data estimates are based on publicly available sources up to 2023, subject to change with new market developments.
