Last updated: February 26, 2026
What is NDC 69238-2597?
NDC 69238-2597 corresponds to Sunitinib malate, marketed under the brand "Sutent." It is an oral tyrosine kinase inhibitor approved for treating renal cell carcinoma, gastrointestinal stromal tumors, and pancreatic neuroendocrine tumors.
Current Market Overview
| Metric |
Data |
Source |
| Year of FDA approval |
2006 |
[1] |
| Market size (2022) |
$950 million |
IMS Health |
| Units sold (2022) |
3.2 million prescriptions |
IQVIA |
| Market segment |
Oncology |
Drugs.com |
The drug maintains a leading position in targeted oncology treatments, with steady demand driven by its indication expansion.
Competitive Landscape
Major competitors include:
- Axitinib (Inlyta)
- Pazopanib (Votrient)
- Cabozantinib (Cabometyx)
- Other tyrosine kinase inhibitors
Pricing varies based on formulation, dosing, and payer negotiations. Sunitinib's average wholesale price (AWP) is approximately $9,850 per 28-day supply, with negotiated net prices typically 30-50% lower.
Price Trends and Projections
Historical Price Data (2018-2022)
| Year |
Average Wholesale Price (AWP) per 28-day supply |
Comments |
| 2018 |
$9,850 |
Base reference |
| 2019 |
$9,850 |
No significant change |
| 2020 |
$9,700 |
Slight decrease due to patent expiry fears |
| 2021 |
$9,650 |
Price stabilization |
| 2022 |
$9,850 |
Slight rebound, increased demand |
Factors Influencing Price Trajectories
-
Patent Status and Generic Entry: The patent expired in 2021 in the US, enabling generic competitors to enter the market. This typically prompts a 25-50% reduction in net prices, though manufacturers' supply agreements and negotiations can alter this.
-
Market Penetration and Prescribing Trends: Increase in new indications may sustain demand, tempering price decline. Biooriginal drugs tend to retain higher prices compared to generics.
-
Regulatory and Policy Changes: Price regulation efforts or new reimbursement policies could influence net prices.
-
Supply Chain Dynamics: Manufacturing disruptions can cause temporary price increases.
Projected Price Path (Next 3 Years)
| Year |
Expected AWP per 28-day supply |
Notes |
| 2023 |
$8,500 - $9,000 |
Post-generic entry, prices decline but stabilize due to demand. |
| 2024 |
$7,500 - $8,000 |
Increased generic competition reduces prices further. |
| 2025 |
$6,500 - $7,000 |
Market stabilizes at a lower price point, with some premium on branded formulations. |
Revenue and Market Share Projections
| Year |
Market Size (USD) |
Estimated Market Share |
Revenue Projection (USD) |
Comments |
| 2023 |
$950 million |
15-20% |
$142 million - $190 million |
Based on demand stability |
| 2024 |
$900 million |
15% |
$135 million |
Slight decline due to generics |
| 2025 |
$850 million |
10-15% |
$85 million - $128 million |
Conservative estimate |
Strategic Implications
-
Patent expiration: generic entry will sharply reduce net prices, pressuring manufacturer margins.
-
Market expansion: off-label uses and new combination regimens could sustain demand, counteracting price decline.
-
Pricing negotiations: payers will push for lower prices, especially in managed care, influencing net revenue.
Summary
| Key Data Point |
Value |
| Current list price |
~$9,850 per 28-day supply |
| Price after patent expiration |
Expected to decline to ~$6,500-7,000 by 2025 |
| Market forecast |
Steady decline in net prices post-generic entry, with market share reducing accordingly |
Key Takeaways
- The upcoming patent expiry significantly impacts pricing, with an estimated 25-30% reduction in net prices.
- Market share is expected to decline as generics penetrate, though demand may persist in select indications.
- Price stabilization could occur within three to four years, following an initial decline.
- Revenue projections will decrease proportionally with net prices unless new indications or combination therapies extend the product's lifecycle.
- Competitive pressure from newer tyrosine kinase inhibitors may influence long-term pricing and market share dynamics.
FAQs
1. When does patent expiration typically occur for NDC 69238-2597?
The patent expired in 2021, enabling generics to enter the US market.
2. How do generic entry and biosimilar development impact prices?
Generic entry generally reduces prices by 25-50%, depending on competition and market demand.
3. Are there any upcoming regulatory interventions affecting pricing?
Current policies focus on transparency and negotiations, but no specific regulations target this product. Future policy shifts could influence prices further.
4. What are the key factors influencing demand for sunitinib?
Demand is driven by its approved indications, off-label use, and emerging combination therapies.
5. How will competition affect long-term revenue projections?
Increased competition from generics and newer therapies is likely to reduce revenues over time unless new indications or formulation innovations emerge.
References
[1] U.S. Food and Drug Administration. (2006). Summary: Sunitinib malate. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021441s000lbl.pdf
