Last updated: February 28, 2026
What is NDC 49502-0101?
NDC 49502-0101 corresponds to Sunitinib malate, marketed under the brand Sutent. It is an oral tyrosine kinase inhibitor used primarily for metastatic renal cell carcinoma, gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors.
Market Landscape
Market Size and Demand
- Global Sales: Sales of Sunitinib reached approximately $1.2 billion in 2022, with the U.S. accounting for around 60% of this revenue.
- U.S. Market Share: The drug is commercially available via FDA approval since 2006. It has served as a standard treatment for renal cell carcinoma for over a decade.
- Patient Population:
- Renal cell carcinoma: ~65,000 diagnosed annually in the U.S.
- GIST: ~5,000 new cases annually.
- Pancreatic neuroendocrine tumors: ~10,000 diagnosed annually.
- Market Growth Drivers:
- Increasing incidence of renal cell carcinoma and GIST.
- Expanded indications and newly approved combination therapies.
- Rising adoption due to improved survival outcomes.
Competitive Landscape
-
Key Competitors:
- Pazopanib (Votrient)
- Axitinib (Inlyta)
- Cabozantinib (Cabometyx)
- Sorafenib (Nexavar)
-
Market Position:
- Sunitinib remains a first-line therapy for renal cell carcinoma.
- Competitive pressure from newer agents with better tolerability or efficacy.
-
Patent Status:
- Patent expired for the original formulation in 2021.
- Biosimilars and generics introduced, affecting prices and market dynamics.
Price Trends and Projections
Historical Pricing
Price Drivers
- Patent expiry increased generic/biosimilar competition.
- Insurance coverage and reimbursement policies influence net prices.
- Manufacturing costs for biosimilars are lower but still impact pricing.
- Negotiated prices with payers in the U.S. vary by provider and formulary.
Future Price Projections (Next 5 Years)
| Year |
Price Range (monthly) |
Remarks |
| 2023 |
$6,500 - $8,500 |
Increasing biosimilar market penetration |
| 2024 |
$6,000 - $8,000 |
Price stabilization as market matures |
| 2025 |
$5,500 - $7,500 |
Further biosimilar entry, potential discounts |
| 2026 |
$5,000 - $7,000 |
Domination of biosimilars, reduction in brand sales |
| 2027 |
$4,500 - $6,500 |
Price plateau with dominant biosimilars |
Factors Influencing Future Pricing
- Biosimilar uptake rate: Expected to reach 70-80% in the U.S. by 2026.
- Reimbursement policies: Changes could pressure prices downward.
- Continued development of new therapies: May reduce demand intensity over time.
- Regulatory decisions: Patent extensions or new formulations could influence price trends.
Regulatory and Policy Impact
- Biosatellite approvals by FDA in 2022-2023 led to increased market competition.
- CMS and private insurers incentivize biosimilar substitution to reduce costs.
- Pricing transparency initiatives could influence negotiated rates.
Summary of Key Data
| Data Point |
2022 |
2023 Projection |
Notes |
| U.S. annual sales |
$720M |
$680M - $740M |
Declining with biosimilar market entry |
| Monthly price (brand) |
$12,000 |
$6,500 - $8,500 |
Price reductions due to biosimilar entries |
| Biosimilar market share in the U.S. |
NA |
50-60% |
Increasing as more generics enter the market |
| Patent expiration date |
2021 |
N/A |
Leads to generic/biosimilar competition |
Key Takeaways
- NDC 49502-0101 (Sunitinib) is experiencing declining prices due to biosimilar competition post-patent expiry.
- Market demand remains steady, supported by its clinical indications, but faces growth limitations from newer therapies.
- Price projections suggest continued decline over the next five years, stabilizing at lower levels as biosimilars dominate.
- Patent and regulatory developments will influence future market dynamics and pricing.
- Payers increasingly favor biosimilars, which exert downward pressure on drug prices.
FAQs
1. What factors primarily affect the price of NDC 49502-0101?
Patent expirations, biosimilar entry, payer negotiations, and regulatory policies.
2. How will biosimilar competition influence the market?
It will significantly reduce prices, potentially limiting revenue growth for the original brand.
3. Is NDC 49502-0101 likely to maintain market share with biosimilars?
Yes, especially in the short to medium term, but market share may decline over time.
4. Are there upcoming patent or regulatory changes that could impact pricing?
Potential patent extensions or new formulations could temporarily stabilize or increase prices; biosimilar approvals drive long-term downward trends.
5. What are the major indications driving demand for NDC 49502-0101?
Renal cell carcinoma, GIST, and neuroendocrine tumors continue to sustain demand, though newer therapies could influence future growth.
References
- IQVIA. (2022). Pharmaceutical Market Review.
- FDA. (2023). Biosimilar Approval and Market Entry.
- CMS. (2022). Biosimilar Substitution Policies.
- EvaluatePharma. (2023). Worldwide Market Data.
- Manufacturer disclosures and earnings reports.
