Last updated: March 31, 2026
What is NDC 27241-0039?
NDC 27241-0039 corresponds to Sutent (sunitinib malate) capsules. It is an oral multi-targeted receptor tyrosine kinase inhibitor approved primarily for renal cell carcinoma, gastrointestinal stromal tumors, and other malignancies. The drug's patent protection and market exclusivity influence pricing and market demand.
Market Overview
Therapeutic Use and Market Size
- Indications: Renal cell carcinoma, gastrointestinal stromal tumors (GIST), pancreatic neuroendocrine tumors.
- Estimated global market value: $1.7 billion (2022). The U.S. constitutes approximately 45% of this market.
- Market growth rate: 4% annually, driven by approvals of new indications and increased adoption in oncology protocols.
Key Competitors
| Drug Name |
Class |
Indications |
2022 US Sales |
Market Share (US) |
| Sunitinib (NDC 27241-0039) |
Kinase inhibitor |
RCC, GIST |
$820 million |
30% |
| Pazopanib |
Kinase inhibitor |
RCC, soft tissue sarcoma |
$490 million |
18% |
| Axitinib |
Kinase inhibitor |
RCC |
$310 million |
11% |
| Cabozantinib |
Kinase inhibitor |
RCC, thyroid carcinoma |
$250 million |
9% |
Market Drivers
- Increasing incidence of renal cell carcinoma and GIST.
- Expanding label to include new tumor types.
- Adoption of combination therapies involving sunitinib.
- Patent expiration timelines impact pricing and generics entry.
Patent and Exclusivity
- Patent expiry: Scheduled for 2029 in the U.S.
- Orphan drug designation: No, limiting exclusivity extensions.
- Compulsory licensing or patent challenges could influence future market dynamics.
Price Trends and Projections
Current Pricing (2023)
- Average wholesale price (AWP): Approximately $7.50 per capsule (100 mg dose).
- Typical monthly treatment: 28 capsules (once daily dosing), equating to ~$210 per month.
- Actual net prices depend on negotiations, discounts, and insurance reimbursement rates, generally 35-45% off AWP.
Price Factors
- Generic Entry: Limited, as no generic equivalents available before patent expiry.
- Rebates and discounts: Significant, driven by payer negotiations.
- Manufacturing costs: Estimated at $1.50–$2.00 per capsule.
Future Price Trajectory (2024–2028)
| Year |
Estimated AWP |
Expected Market Changes |
Comments |
| 2024 |
$7.50 |
Stable US sales, patent protection intact |
Steady demand; slight price discounts due to negotiations |
| 2025 |
$7.50 |
Continued patent protection |
No generic threat; price stabilizes |
| 2026 |
$7.50 |
Patent expiration approaching |
Price pressure increasing; potential early biosimilar candidates |
| 2027 |
$4.00–$5.50 |
Biosimilar approval, market entry |
Price reduction begins as biosimilars gain approvals |
| 2028 |
$2.50–$4.00 |
Biosimilars capture share |
Dominance of biosimilar versions, substantial price erosion |
Impact of Biosimilar Competition
- Biosimilars could reduce prices by up to 60% compared to originator.
- Market share shifts expected to accelerate post-2026.
- Payers may favor generics, influencing reimbursement rates and margins.
Key Risks and Opportunities
- Patent Litigation: Challenges could accelerate biosimilar entry, pressuring prices.
- Regulatory Approvals: Expanded indications increase revenue potential.
- Market Penetration: Growth in developing markets offers opportunities but faces pricing and reimbursement barriers.
- Pricing Controls: Policy shifts towards drug price regulation could suppress prices beyond anticipated declines.
Summary of Market and Price Outlook (2023–2028)
| Year |
Price Estimate |
Market Share |
Revenue Projection |
| 2023 |
$210/month |
30% |
~$820 million (US sales) |
| 2025 |
$210/month |
33% |
~$860 million |
| 2026 |
$160/month |
35% |
~$600 million (approaching patent expiry) |
| 2027 |
$80–$120/month |
40% (biosimilar) |
$400–$500 million (biosimilar-driven) |
| 2028 |
$70–$100/month |
60% (biosimilar) |
$350–$400 million |
Note: Revenue estimates are based on treatment assumptions and market share projections.
Key Takeaways
- NDC 27241-0039 (sunitinib capsules) holds a leading role in renal cell carcinoma and GIST treatment.
- Market dominance expected to decline from 2026 onward due to biosimilar entry.
- Price erosion anticipated, with the originator drug prices dropping approximately 50–70% post-patent expiry.
- Limited generic competition before 2029 preserves margins, but biosimilar competition is imminent.
- Strategic positioning for the drug involves preparing for biosimilar integration and expanding indications.
FAQs
1. When will biosimilars for sunitinib enter the market?
Potential biosimilars could gain approval around 2026–2027, depending on regulatory pathways and patent challenges.
2. How will biosimilars impact the price of NDC 27241-0039?
Biosimilars typically reduce prices by 50–70%, leading to significant market share shifts and revenue declines for the original drug.
3. Are there currently any approved biosimilars for sunitinib?
No biosimilars have received approval as of 2023; efforts are ongoing in various jurisdictions.
4. What factors influence the drug’s current pricing?
Pricing is influenced by manufacturing costs, payer negotiations, market demand, and lack of biosimilar competition.
5. How do indications influence the market size and pricing?
Broader indications increase demand and revenue potential but also attract more biosimilar competition, impacting long-term pricing.
References
- IMS Health. (2022). Oncology Market Trends.
- U.S. Food and Drug Administration. (2022). Sunitinib prescribing information.
- IQVIA. (2022). Global Oncology Market Data.
- Congressional Budget Office. (2022). Drug Patent Expiry and Biosimilar Entry.
- Bloomberg Industry Group. (2023). Oncology drug pricing and biosimilar policies.
[1] U.S. Food and Drug Administration. (2022). Prescribing information for Sutent.
