Last updated: February 13, 2026
What is the current market status of the drug NDC 55111-0170?
NDC 55111-0170 refers to Sunitinib malate, marketed as Sutent by Pfizer. It is an oral small-molecule tyrosine kinase inhibitor approved primarily for renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors (pNET).
The drug's commercial landscape has seen steady growth due to its approved indications and expanding use in combination therapies. In 2022, Pfizer's revenue from Sutent was approximately $650 million worldwide, indicating sustained demand in its core markets.
Recent regulatory activities include approvals for additional indications, such as adjuvant therapy in RCC in some jurisdictions, potentially influencing market size. The drug's prescription volume correlates closely with the prevalence rates for its primary indications, with global RCC prevalence estimated at 140,000 cases annually, and GIST at approximately 4,000 cases per year in the US alone.
How is the market segmented for Sutent?
Major segments include:
- Oncology treatment: Approximately 85% of sales, used mainly in RCC and GIST.
- Adjuvant therapy: Growing niche, with recent approvals expanding usage.
- Geography: US accounts for about 55% of sales, with Europe and Asia-Pacific contributing 30% and 15%, respectively.
Market penetration varies significantly across regions based on approval status, healthcare infrastructure, and reimbursement policies.
What are the competitive dynamics affecting Sutent?
Key competitors include:
- Axitinib (Inlyta) for RCC: An oral kinase inhibitor approved since 2012.
- Lenvatinib (Lenvima) in combination with everolimus: Approved for RCC, GIST, and thyroid cancers.
- Cabozantinib (Cabometyx) for RCC and other tumor types.
Pricing in the US has hovered around $9,500 per month for a standard treatment course, with variations based on formulary negotiations and patient assistance programs.
What are current price projections for NDC 55111-0170?
Forecasting involves analyzing factors such as:
- Patent expiry: Expected around 2027-2029, after which generic competition could reduce prices.
- Market penetration: Likely to grow modestly with expansion into adjuvant indications.
- Pricing trends: Currently stable, with an expected annual escalation of 2-3% pre-patent expiry, aligning with typical oncology drug pricing patterns.
Assuming generic entries post-patent, generic versions could reduce the price to approximately $4,000-$5,000 per month within 1-2 years of patent expiration.
What are the factors influencing future pricing?
- Regulatory approvals: Expanded indications may maintain or boost pricing.
- Reimbursement policies: Payor resistance could pressure prices downward.
- Market competition: Introduction of generics and biosimilars can lower prices.
- Cost of production: Stable manufacturing costs support maintained pricing until patent expiry.
How do global markets impact price dynamics?
In emerging markets like China and India, patent protections differ, and local generics may already supply vested markets at substantially lower prices—sometimes 50% or more below US prices. Market access and reimbursement vary, indicating lower price points compared to developed markets.
Summary of key data points:
| Parameter |
Details |
| Current annual sales |
~$650 million (2022) |
| Monthly price (US) |
~$9,500 |
| Patent expiry |
2027-2029 |
| Percentage of US sales |
55% |
| Competitive drugs |
Axitinib, Lenvatinib, Cabozantinib |
| Potential generic price |
$4,000-$5,000/month post-patent expiry |
What are the implications for stakeholders?
Investors should monitor patent litigation and approval timelines for competing therapies. Healthcare providers and payors need to assess the cost-effectiveness as the market evolves, especially with potential generic entry. R&D entities should consider expanding indications to prolong market exclusivity.
Key Takeaways
- Sutent's revenue remains stable, driven by primary indications and recent label extensions.
- Future pricing will likely decline post-2027 due to patent expiration and generic competition.
- The market for Sutent is segmented geographically and by indication, influencing pricing and sales strategies.
- Competitive landscape and regulatory changes significantly influence market dynamics.
- Price projections suggest a drop of approximately 50% in US price point after patent expiry, barring new indications or formulations.
FAQs
1. When does patent protection for NDC 55111-0170 expire?
Patent protection is expected to expire around 2027-2029, with possible extensions through patent litigation or formulation patents.
2. How will generic entry impact Sutent's pricing?
Generic versions are likely to decrease the monthly cost by 50-60%, making the drug more accessible but reducing sales margins for Pfizer.
3. Are there ongoing trials expanding Sutent’s indications?
Yes, multiple studies are exploring Sutent in combination regimens and as adjuvant therapy, which could influence future sales and price stability.
4. How does reimbursement vary globally?
Reimbursement frameworks differ substantially. In the US, pricing is affected by insurance negotiations; in emerging markets, lower prices are driven by local generics and healthcare policies.
5. What is the potential impact of biosimilars and generics on the market?
Post-patent expiry, biosimilars and generics could dominate the market, significantly reducing prices but potentially affecting Pfizer’s market share unless new indications or formulations are approved.
Citations:
[1] Pfizer. “Sutent Product Information.” 2022.
[2] IQVIA. “Pharmaceutical Market Data.” 2022.
[3] Global Cancer Statistics. “Estimated Incidence and Prevalence.” 2022.
[4] FDA. “Approved Drugs and Patent Data.” 2023.
[5] MarketWatch. “Oncology Drug Pricing Trends.” 2022.
