Last updated: February 20, 2026
What is the drug associated with NDC 62559-0522?
NDC 62559-0522 refers to Sutent (sunitinib malate) 50 mg capsules. Sunitinib is an oral tyrosine kinase inhibitor used in the treatment of several cancers, including renal cell carcinoma, gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors.
Market Size and Patient Population
Indications and Estimated Patient Numbers
| Indication |
Approved Use |
U.S. Patients (2022 est.) |
Global Patients (2022 est.) |
| Renal Cell Carcinoma |
First-line and metastatic |
76,000 |
300,000 |
| Gastrointestinal Stromal Tumors (GIST) |
Second-line therapy after imatinib failure |
14,000 |
50,000 |
| Pancreatic Neuroendocrine Tumors |
Advanced cases |
12,000 |
30,000 |
Sources: American Cancer Society [1], Global Cancer Statistics [2], Market research reports [3]
Market Drivers
- Growing incidence of targeted cancers.
- Expanding indications, including adjuvant therapy.
- Increasing adoption in combination therapy regimens.
Competitive Landscape
Key Competitors
- Regorafenib (Stivarga): Similar kinase inhibitor, used in GIST.
- Axitinib (Inlyta): Primarily for renal cell carcinoma.
- Lenvatinib (Lenvima): Multiple tumor types, including thyroid and renal cancers.
Market Share Estimates (2022)
| Drug |
Estimated Global Market Share |
Revenue (USD bio.) |
Notes |
| Sunitinib |
30% |
1.2 |
Leading in renal and GIST markets |
| Regorafenib |
15% |
0.5 |
Growing due to GIST and colorectal |
| Axitinib |
20% |
0.7 |
Increasing in RCC indications |
| Lenvatinib |
35% |
1.4 |
Broader approvals, expansion |
Note: Market share figures are estimates based on sales, patent data, and market reports [4]
Pricing Analysis
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per 50 mg capsule |
Notes |
| 2018 |
$6,800 |
Initial launch price |
| 2020 |
$6,000 |
Price decrease via discounts |
| 2022 |
$5,250 |
Due to biosimilar competition |
Current Price (2023)
- Average Wholesale Price (AWP): Approximately $5,250 per capsule.
- Average Sale Price (ASP): Estimated at $4,800 per capsule.
- Rebates and discounts: Lead to net prices close to $3,600 per capsule.
Price Projections (Next 5 Years)
| Year |
Predicted AWP per 50 mg capsule |
Drivers |
| 2024 |
$5,000 |
Patent exclusivity remaining, limited biosimilar impact |
| 2025 |
$4,750 |
Increased biosimilar entry expected, price pressure |
| 2026 |
$4,500 |
Market consolidation, generic availability |
| 2027 |
$4,250 |
Competitive biosimilar proliferation |
| 2028 |
$4,000 |
Biosimilar market maturity, volume growth |
Assumptions: Price decreases driven by biosimilar development, market expansion, and payer negotiations [5]
Biosimilar and Patent Landscape
- Current patent exclusivity is expected to expire between 2023-2024.
- Several biosimilars in advanced stages of development, with FDA approvals anticipated from 2023 onward.
- Biosimilar entry typically reduces prices by 15-35% in the first two years post-launch [6].
Regulatory and Pricing Policies Impacting Future Market
- U.S.: Value-based contracting and rebates influence net prices. Medicare Part D negotiations may impact pricing strategies.
- Europe: Price regulations, Reimbursement policies, and Health Technology Assessments limit list prices.
- Emerging Markets: Lower pricing driven by generic competition and licensing agreements.
Key Takeaways
- The global market for sunitinib is expected to grow moderately, driven by expanding indications and regional increases in cancer incidence.
- Current prices are declining in response to biosimilar competition, with average prices dropping approximately 23% from 2018 to 2022.
- Price projections indicate continued declines, averaging around $4,000 per capsule by 2028.
- Patent expiration in 2023-2024 will accelerate biosimilar market entry, exerting downward pressure.
- Competition from alternate therapies and combination regimens could impact market share.
FAQs
1. What is the primary therapeutic use of NDC 62559-0522?
Sunitinib 50 mg capsules are used to treat renal cell carcinoma, GIST, and pancreatic neuroendocrine tumors.
2. How does the price of sunitinib compare to its biosimilars?
Biosimilars typically cost 15-35% less than originator sunitinib, with prices falling further as more biosimilars enter the market.
3. What factors influence the future pricing of sunitinib?
Patent expiration, biosimilar entry, payer negotiations, and regulatory policies are primary influences.
4. Will the market for sunitinib expand?
Yes, due to new indications and increasing cancer prevalence, but growth may be tempered by competition and alternative therapies.
5. How reliable are the price projections?
Projections rely on current patent and biosimilar timelines, market trends, and policy estimates; unexpected regulatory or scientific developments could alter outcomes.
References
[1] American Cancer Society. (2022). Cancer Statistics.
[2] Global Cancer Observatory. (2022). GLOBOCAN Data.
[3] Market Research Future. (2023). Oncology Drug Market Analysis.
[4] IQVIA. (2022). Global Oncology Market Data.
[5] EvaluatePharma. (2023). Oncology Drug Price Trends.
[6] IMS Health. (2022). Biosimilar Market Trends.
