Last updated: February 17, 2026
What is the Drug and Its Approved Indication?
The drug with NDC 65862-0746 corresponds to Sutent (sunitinib malate). It is an oral tyrosine kinase inhibitor approved for multiple cancer types, including renal cell carcinoma, gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors (pNET).
Market Size and Dynamics
Current Market Landscape
- Global oncology drug market: Valued at approximately $160 billion in 2022, with targeted therapies representing growing segments.
- Sutent’s market share: Estimated at 8% within targeted oncology treatments, driven by its FDA approvals and multiple indications.
Key Competitors
| Drug Name |
Indications |
Market share (est.) |
Price Range (per 30-day supply) |
| Nexavar (sorafenib) |
Renal cell carcinoma, hepatocellular carcinoma |
10% |
$12,000 – $14,000 |
| Avastin (bevacizumab) |
Colorectal, lung, ovarian cancers |
15% |
$7,000 – $15,000 |
| Sutent (sunitinib) |
Renal cell carcinoma, GIST, pNET |
8% |
$9,000 – $12,000 |
Market Drivers
- Expansion of indications.
- Increased prevalence of target cancers.
- Adoption of targeted therapies over chemotherapy.
Regulatory Landscape
- FDA approval date: January 26, 2006.
- Recent updates: Expanded indications in 2022 for combination therapy in specific pancreatic neuroendocrine tumors.
Price History and Trends
- 2006: Launch price at approximately $10,000 per 30-day supply.
- 2015: Price increased to $11,500, driven by inflation, manufacturing costs, and expanded indications.
- 2022: Noted fluctuations; average price remains within $9,000 – $12,000 range, with some discounts and payer negotiations affecting net prices.
Pricing Considerations
- Price discounts are common among insurers using negotiated rebates.
- Availability of generic sunitinib is limited; patent exclusivity remains until 2025 in the US.
- Price increases are primarily driven by inflation, R&D recoupment, and market demand.
Future Price Projections
Factors Influencing Future Pricing
- Patent expiration: Patents expire in 2025, opening markets for generics.
- Generic entry: Expected to drive prices down by 50% within 1-2 years post-approval.
- Orphan drug status: May extend exclusivity or incentivize high pricing for rare indications.
- Market competition: Introduction of biosimilars or new targeted therapies could pressure prices.
Projected Pricing Range (2024–2028)
| Year |
Estimated Price Range |
Notes |
| 2024 |
$8,000 – $11,000 |
Limited generic competition, negotiations vary. |
| 2025 |
$4,000 – $6,000 |
Post-patent expiry, generics enter the market. |
| 2026 |
$3,000 – $5,000 |
Increased competition, discounts maintained. |
| 2027 |
$2,500 – $4,000 |
Biosimilars gain market share. |
| 2028 |
$2,000 – $3,500 |
Market stabilization with multiple generics. |
Market Outlook Summary
- Growth expected due to new indications and combination therapies.
- Price declines anticipated with generic availability.
- Cost containment pressure may limit price increases moving forward.
Key Takeaways
- NDC 65862-0746 corresponds to Sutent (sunitinib malate), a broad-spectrum targeted therapy for various cancers.
- Market size estimated at roughly $1.3 billion globally, with competition from Nexavar and Avastin.
- Price has stabilized around $9,000–$12,000 per 30-day supply, with potential drops after patent expiry.
- Generic entry in 2025 will significantly influence pricing and market dynamics.
- Future pricing will depend on competition, indication expansion, and payer negotiations.
FAQs
1. When will generic versions of Sutent become available?
Generics are expected to enter the US market after patent expiration, projected in 2025.
2. How much will the price of Sutent decrease once generics launch?
Prices could decline by approximately 50%, dropping to $4,000–$6,000 per 30-day supply within 1-2 years.
3. What are the primary indications for Sutent?
Renal cell carcinoma, gastrointestinal stromal tumors, and pancreatic neuroendocrine tumors.
4. How does Sutent compare to competitors in price?
While currently priced at $9,000–$12,000, it is comparable to Nexavar but higher than some biosimilars once available.
5. Are there ongoing clinical trials affecting future approvals?
Yes, trials are ongoing for additional indications and combination regimens, which could affect demand and pricing strategies.
References
- IMS Health. (2022). Oncology drug market report.
- U.S. Food and Drug Administration. (2006). FDA approval package for Sutent.
- EvaluatePharma. (2022). Global oncology market insights.
- SSR Health. (2023). Pharmaceutical market pricing and volume data.
- U.S. Patent and Trademark Office. (2022). Patent expiration dates for sunitinib.
