Last updated: March 16, 2026
What is NDC 23155-0797?
NDC 23155-0797 identifies a specific drug product, likely a biologic or small molecule medication. Based on the National Drug Code directory, this code currently corresponds to Sunitinib malate, marketed under the brand name Sutent, used primarily for renal cell carcinoma and gastrointestinal stromal tumors.
Market Overview
Current Market Size
The global oncology drug market was valued at approximately USD 135 billion in 2022. Sunitinib accounts for a significant share of the targeted therapy segment, especially in renal cell carcinoma.
Approvals & Indications
Sunitinib was first approved by the FDA in 2006. It holds approvals for:
- Renal cell carcinoma (RCC)
- Gastrointestinal stromal tumors (GIST)
- Other rare tumor types (e.g., pancreatic neuroendocrine tumors)
Additional patents and exclusivity periods influence launch and pricing strategies.
Competitive Landscape
Major competitors include:
- Pazopanib (Votrient)
- Axitinib (Inlyta)
- Cabozantinib (Cabometyx)
Market share is driven by efficacy, safety profile, and pricing.
Patent & Exclusivity Timeline
The original patent for Sunitinib expired in 2018. However, patent extensions and formulation patents have prolonged exclusivity. Patent cliff expected around 2024-2025.
Pricing Dynamics
- Brand Name (Sutent): USD 12,800–15,000 per month in the US.
- Generic Prices: Potentially USD 8,000–10,000 per month post-patent expiration.
Price Projections
Short-Term (Next 1-2 Years)
- The drug will retain its market position with minimal price erosion due to ongoing patent protections until 2024-2025.
- Price range expected to stay roughly USD 12,000–15,000 per month.
- Reimbursement negotiations and insurer contracts influence net prices but do not significantly alter list prices.
Medium to Long-Term (3-5 Years)
- Entry of generics would likely reduce list prices by 30-50%.
- Post-patent expiration, list prices could fall to USD 6,000–8,000 per month, similar to competitors' prices.
- Biosimilars and alternative therapies could erode volume, putting downward pressure on prices.
Market Penetration & Volumes
- US annual sales are approximately USD 800 million.
- Growth driven by expanding indications and improved access.
- Mild price erosion could translate to USD 700–USD 750 million annual sales by 2027.
Pricing Factors Influencing Future Values
- Regulatory approvals for additional indications.
- Competitive entry, especially biosimilars.
- Reimbursement policies and insurance coverage.
- Research and development pipeline introducing novel therapies.
Key Market Forces
| Factor |
Impact |
| Patent expiry |
Drives price decline as generics/biosimilars enter market |
| New indications or approvals |
Can sustain or increase prices if approved for niche uses |
| Competitive launches |
Puts pressure on pricing and market share |
| Reimbursement policies |
Influence net payor prices and access |
Summary
The current list price for NDC 23155-0797 (Sunitinib) remains USD 12,000–15,000 per month. Patent expiration in 2024-2025 suggests a potential reduction to USD 6,000–8,000. Long-term pricing depends on competitive dynamics, approval of biosimilars, and insurance negotiations.
Key Takeaways
- The drug's market is substantial, with US sales nearing USD 800 million annually.
- Patent expiration around 2024-2025 will trigger significant price erosion.
- Generics could reduce prices by up to 50%, impacting revenue and market share.
- Future growth hinges on additional indications and market expansion.
- Reimbursement and healthcare policies will influence realized prices.
FAQs
-
When does patent protection for NDC 23155-0797 expire?
Patent protections are expected to expire in 2024–2025, opening the market to generics and biosimilars.
-
What factors could prevent significant price declines?
If new indications gain approval or the drug maintains its therapeutic superiority, pricing may remain stable longer.
-
How do biosimilars impact the market?
Biosimilars typically enter 12–24 months post-patent expiry, reducing prices by approximately 30–50%.
-
What is the potential impact of biosimilar competition on sales?
They could capture up to 70% of the market share within two years post-entry, significantly decreasing revenues for the originator.
-
Are there regulatory barriers to biosimilar approval?
Yes, biosimilars require demonstrating similar efficacy, safety, and immunogenicity, which can delay or complicate market entry.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2006). FDA Approval of Sutent.
[3] Statista. (2022). Oncology drug market size.
[4] Medtech Insight. (2023). Biosimilar entry and pricing.
[5] U.S. Patent and Trademark Office. (2023). Patent status for sunitinib.
(Note: The above data combines market reports, regulatory filings, and industry analysis; specific figures may vary and should be verified with current sources.)
