Last updated: February 25, 2026
What is NDC 33342-0156?
NDC 33342-0156 refers to an approved pharmaceutical product. Based on available data, it is identified as Sunitinib Malate (brand name: Sutent), used primarily for treating renal cell carcinoma, gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors. Its approval status and market penetration are critical for precise forecasting.
Current Market Overview
| Parameter |
Details |
| Approval Date |
May 26, 2006 [1] |
| Therapeutic Class |
Tyrosine kinase inhibitor |
| Indications |
Renal cell carcinoma, GIST, pancreatic neuroendocrine tumors [2] |
| Estimated Global Sales (2022) |
$950 million [3] |
| Major Market Regions |
US, European Union, Japan |
| Key Competitors |
Pazopanib, Axitinib, Cabozantinib |
Market Dynamics
Revenue Trends
- The market for sutent and similar therapies has shown consistent growth from 2018 to 2022.
- CAGR approximates 4.5% globally in oncology drugs, driven by increasing cancer prevalence and lack of direct biosimilars.
Market Drivers
- Rising cancer incidence rates, particularly renal cell carcinoma.
- Expanding indications for sunitinib use.
- Improved awareness and diagnostic capabilities.
Market Challenges
- Generic competition materializes typically 10-12 years post-approval.
- Biosimilar entry expected in the next 3-5 years.
Regulatory Landscape
- Patent protection was in effect until approximately 2016-2018 in key territories.
- Recent patent litigations have limited generic entry until 2024 [4].
Price Trends and Projections
Current Pricing
- The average wholesale price (AWP) for a 4.75 mg capsule (standard dose) ranges from $80 to $120 in the US.
- Treatment regimens typically require daily dosing over extended periods, leading to substantial annual costs.
Historical Price Changes
| Year |
Average Wholesale Price (US) |
Notes |
| 2018 |
$90 per capsule |
Pre-generic era |
| 2020 |
$85 per capsule |
Slight decrease, patent litigation ongoing |
| 2022 |
$80 per capsule |
Post-patent expiration preparations |
Price Projection (Next 5 Years)
| Year |
Anticipated Price Range (US) per capsule |
Rationale |
| 2023 |
$80 - $120 |
No generic competition; potential discounts for bulk sales |
| 2024 |
$60 - $100 |
Entry of biosimilars expected to drive prices down [5] |
| 2025 |
$50 - $90 |
Increased biosimilar market share |
| 2026 |
$45 - $80 |
Continued generic penetration, volume-based discounts |
| 2027 |
$40 - $70 |
Market normalization with multiple biosimilars |
Future Market Factors
- Biosimilar development may decrease prices by 20-40% upon launch.
- New indications and combination therapies could reinvigorate sales.
- Regulatory changes affecting patent life and data exclusivity may influence market entry timings.
Competitive Landscape and Entry Barriers
| Competitor |
Status |
Estimated Launch Year |
Price Impact |
| Biosimilar A |
Under development |
2024 |
Downward price pressure |
| Biosimilar B |
Pending approval |
2025 |
Increased competition |
Market entry barriers include patent protections, high R&D costs for biosimilars, and strict regulatory pathways.
Key Takeaways
- NDC 33342-0156 corresponds to sunitinib, a critical oncology agent with a well-established market.
- Total global sales peaked near $950 million in 2022.
- Market prices are declining marginally but remain high due to patent protections.
- Biosimilars poised to reduce prices by approximately 20-40% once launched.
- Ongoing patent disputes or extensions could influence generic entry and pricing.
FAQs
1. When will generics become available for NDC 33342-0156?
Biosimilar competitors are expected to launch between 2024 and 2025, potentially leading to substantial price reductions.
2. How does the current pricing compare to other oncology drugs?
Sunitinib’s prices are comparable to similar tyrosine kinase inhibitors, often in the $80-$120 range per capsule, reflecting its therapeutic value and market exclusivity.
3. What factors could influence future sales?
Emergence of biosimilars, new indications, combination therapies, and regulatory decisions on patent extensions are key factors.
4. Are there significant regional differences in pricing?
Yes, US prices tend to be higher due to payer structures, whereas European markets usually see lower prices, influenced by national negotiations.
5. What is the impact of patent expiration on the market?
Patent expiration enables biosimilar entry, which typically reduces prices and increases market competition.
References:
[1] FDA. (2006). FDA Approved Drugs Database.
[2] DrugBank. (2023). Sunitinib.
[3] IQVIA. (2022). Global Oncology Market Report.
[4] PatentScope. (2023). Patent Litigation and Extensions.
[5] Biosimilar Market Insights. (2022). Upcoming Biosimilar Launches and Price Effects.
Note: Exact prices and timelines remain subject to regulatory developments and market shifts.
