Last updated: March 13, 2026
What is the Drug Identified by NDC 65162-0513?
NDC 65162-0513 corresponds to Sutent (sunitinib malate), an oral tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma, gastrointestinal stromal tumors, and pancreatic neuroendocrine tumors. It is a targeted therapy that inhibits multiple receptor tyrosine kinases involved in tumor growth and angiogenesis.
Current Market Landscape
Market Size and Demand
- Market Volume (2022): Estimated at approximately $1.2 billion globally.
- Key Markets: United States (dominant), European Union, Asia-Pacific.
- Patient Population: Estimated at 20,000–25,000 patients annually in the U.S. for indications covered by Sutent.
- Growth Drivers: Increasing incidence of renal cell carcinoma and neuroendocrine tumors; broader adoption of targeted therapies; expansion of indications, including off-label uses.
Competitive Position
- Major Competitors: Pazopanib (Votrient), cabozantinib (Cabometyx), axitinib (Inlyta).
- Market Share (2022): Sutent held around 35% of the targeted therapy renal cancer market.
Regulatory and Patent Status
- Patent Expiry: Patents for Sutent expired in the U.S. in 2021 for certain formulations; newer patents and exclusivities extend until 2025 in some jurisdictions.
- Regulatory Approvals: Approved by the FDA (2006) and EMA (2007).
Price Trends and Pricing Strategies
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately $10,000–$12,000 per month for a typical adult dose.
- Discounted Cash Price (DCP): Estimated at $8,000–$10,000 per month, after negotiations.
- Per-Patient Annual Cost: Approximately $96,000–$144,000.
Pricing Comparison (2023)
| Drug |
Monthly Price |
Annual Cost |
Indications |
| Sunitinib (Sutent) |
$10,000 |
$120,000 |
Renal cell, GI stromal tumors |
| Pazopanib (Votrient) |
$8,000 |
$96,000 |
Renal cell, soft tissue sarcoma |
| Cabozantinib |
$11,000 |
$132,000 |
Renal, medullary thyroid |
Price Adjustment Factors
- Patent expirations increase generic competition, pressuring average prices downward.
- Insurance negotiations influence payer prices, often reducing costs.
- Manufacturing costs have remained stable due to generic production.
Market Projections (2024–2028)
Revenue Forecasts
| Year |
Estimated Market Size |
Predicted Revenue |
Notes |
| 2024 |
$1.3 billion |
$1.05 billion |
Patent expiries impact pricing |
| 2025 |
$1.2 billion |
$900 million |
Increased generics, price competition |
| 2026 |
$1.1 billion |
$750 million |
Market consolidation, newer competitors |
| 2027 |
$1.0 billion |
$600 million |
Price erosion continues |
| 2028 |
$900 million |
$450 million |
Entry of biosimilars or alternative treatments |
Price Projections (2024–2028)
- Prices are expected to decline by an average of 10–15% annually due to patent expirations and competitive pressures.
| Year |
Estimated Monthly Price |
Estimated Annual Cost |
Percentage Change |
| 2024 |
$8,500 |
$102,000 |
-15% |
| 2025 |
$7,225 |
$86,700 |
-15% |
| 2026 |
$6,140 |
$73,680 |
-15% |
| 2027 |
$5,210 |
$62,520 |
-15% |
| 2028 |
$4,430 |
$53,160 |
-15% |
Factors Influencing Future Pricing and Market Dynamics
- Patent litigation and extensions may prolong exclusivity in certain markets.
- Regulatory pathways for biosimilars or generics can accelerate price reductions.
- China and India expanding biosimilar markets could influence global pricing.
- New indications or combination therapies could sustain or increase demand.
Key Takeaways
- Sutent's global market was approximately $1.2 billion in 2022.
- Its price has stabilized around $10,000 monthly for brand versions, with reductions forecasted in line with patent expirations and generic competition.
- Price erosion projected at approximately 15% annually from 2024 to 2028.
- Revenue declines are anticipated as generics and biosimilars gain market share.
- The drug's market share remains significant in renal and neuroendocrine tumors, but competition from newer agents is increasing.
FAQs
1. What factors could slow price declines for Sutent?
Patent protections, limited generic manufacturing, or regulatory delays could keep prices higher longer.
2. How do biosimilar versions of sunitinib impact the market?
Biosimilars could reduce prices by 30–50%, significantly impacting revenue and market share.
3. Are there markets with higher or lower prices?
Yes. The U.S. tends to have higher prices due to less price regulation, while countries in Europe and Asia often see lower prices.
4. Will new indications prolong Sutent’s market exclusivity?
Potentially. Additional approvals or clinical trials could extend patent protection or market life.
5. How does the competitive landscape influence pricing?
Increased competition from generics or kinases targets drives prices down and reduces profit margins.
References
[1] IQVIA. (2022). Global Oncology Market Analysis. Retrieved from [IQVIA database].
[2] FDA. (2006). Approval letter for Sutent. Retrieved from https://www.fda.gov
[3] Evaluate Pharma. (2023). Cancer drug market forecasts. Retrieved from www.evaluate.com
[4] U.S. Patent and Trademark Office. (2022). Patent expiry data for sunitinib. Retrieved from https://www.uspto.gov
