Last updated: March 3, 2026
What is NDC 27241-0301?
NDC 27241-0301 refers to a specific drug formulation registered under the National Drug Code (NDC) system. This particular code corresponds to Sunitinib Malate (generic name), used primarily for treating renal cell carcinoma and gastrointestinal stromal tumors (GIST). It is marketed as Sutent by Pfizer.
Market Overview
Therapeutic Area and Demand Drivers
- Indications: Renal cell carcinoma, GIST, pancreatic neuroendocrine tumors.
- Market Size (2022): Estimated at $1.2 billion globally, with the U.S. accounting for approximately 60% of sales [1].
- Growth Factors:
- Increasing prevalence of renal cancers.
- Expanding use in adjuvant therapy.
- Expansion into new indications such as other solid tumors.
Competitive Landscape
- Main competitors include other tyrosine kinase inhibitors like Pazopanib, Axitinib, and Cabozantinib.
- Patent exclusivity cliff expected in 2026, with potential for biosimilars entering the market thereafter.
- Patent litigation and legal challenges influence market stability.
Regulatory Status
- FDA approval granted in 2006.
- Approved in Europe (EMA) in 2006.
- No significant recent regulatory changes but ongoing post-marketing surveillance.
Price Trends and Projections
Current Price Dynamics
- Average Wholesale Price (AWP): Approximately $11,500 per 30-day supply in the U.S.
- Actual Transaction Price: Typically 50-70% of AWP for payers and pharmacies.
- Reimbursement rates: Vary by payer, with negotiated discounts reducing patient and provider costs.
Cost Factors Influencing Price
- Manufacturing complexity of kinase inhibitors.
- Patent protections providing monopoly pricing.
- Distribution and supply chain costs.
- Generic/biosimilar entry risks.
Price Trajectory Forecast (Next 5 Years)
| Year |
Estimated Average Price per 30-Day Supply |
Notes |
| 2023 |
$11,000 |
Current stable pricing, with slight discounts to payers. |
| 2024 |
$10,500 |
Price erosion begins as off-patent biosimilars develop. |
| 2025 |
$9,500 |
Biosimilars approved, increased market competition. |
| 2026 |
$8,500 |
Patent expiry; biosimilar market expands. |
| 2027 |
$7,500 |
Market stabilizes at lower price levels. |
Note: These projections assume typical patent cliff effects, biosimilar entry, and payer negotiations.
Impact of Biosimilar Competition
- Biosimilars for sunitinib are expected to enter the market within 2-3 years post patent expiry.
- First bios germany filed in 2024, with U.S. filings expected by 2025.
- Price reductions of 30-50% anticipated post-approval.
Market Opportunities and Risks
Opportunities
- Expansion into new tumor types and indications.
- Potential for combination therapies increasing market share.
- Growth in emerging markets with rising cancer incidence.
Risks
- Biosimilar and generic competition reducing profit margins.
- Regulatory delays or restrictions.
- Price regulation efforts at the federal and state level.
- Patent litigation outcomes affecting market exclusivity.
Key Takeaways
- NDC 27241-0301 (sunitinib) has a current high price due to patent protections.
- Market size is substantial, driven by renal and gastrointestinal cancers.
- The pricing outlook indicates a decline starting from 2024, accelerated by biosimilar entry.
- Rising competition and patent expiry will pressure prices, but current demand remains solid.
- Expansion into new indications and markets offers revenue growth potential.
FAQs
1. When will biosimilars for NDC 27241-0301 likely enter the market?
Biosimilars are expected to enter after patent expiration around 2026-2027, with filings starting by 2024-2025.
2. How does patent expiration impact the drug’s price?
Patent expiry typically triggers price erosion due to biosimilar competition, with discounts of 30-50% expected.
3. What are the key indications driving demand for this drug?
Renal cell carcinoma and GIST are primary drivers, with expanding use in related tumors.
4. What factors could influence the price projections?
Regulatory changes, patent litigation, biosimilar market penetration, and payer negotiations.
5. Are there ongoing efforts to develop alternative therapies?
Yes, new kinase inhibitors and combination therapies are in development, potentially affecting future market dynamics.
References
[1] IQVIA. (2022). Pharmaceutical Market Data. IQVIA Reports.
[2] FDA. (2022). Drug Approved Indications. U.S. Food and Drug Administration.
[3] EvaluatePharma. (2022). World Preview 2022, Outlook to 2027. Evaluate.
