Last updated: February 27, 2026
What is NDC 57664-0690?
NDC 57664-0690 corresponds to Stivarga (regorafenib), an oral kinase inhibitor indicated for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma. It is marketed by Bayer and approved by the FDA in 2012.
Current Market Landscape
Market Size and Adoption
- Global sales: Approximately $800 million in 2022, reflecting steady growth driven by approved indications.
- Market penetration: Higher in the U.S., with increasing adoption in Europe and Asia-Pacific.
- Patient population:
- Colorectal cancer: ~135,000 new cases annually in the U.S.
- GIST: ~5,000 cases annually.
- HCC: ~42,000 cases annually.
Not all patients are eligible; estimates suggest that 60-70% of metastatic cases may receive regorafenib as line of therapy.
Competition
Key competitors include:
- Regorafenib (Stivarga): First-in-class.
- Lenvatinib: Approved for HCC.
- Sorafenib: Approved for HCC and renal cell carcinoma.
- Cabozantinib: Approved for GIST and HCC.
Market share is roughly split, with Stivarga holding approximately 50%, depending on the region.
Pricing Benchmarks
- U.S. price: Approx. $11,000 per month for a typical 40 mg daily dose.
- International prices: Vary from $5,000 to $9,000, often lower due to reimbursement policies.
Reimbursement and Access
- Coverage supported by Medicare, Medicaid, and private insurers.
- Cost-effectiveness thresholds vary, influencing formulary placement.
Price Projections and Future Outlook
Factors Influencing Price Trends
- Patent exclusivity: Patents extend until at least 2025, barring patent challenges or extensions.
- Generics: No generics available currently; biosimilar options unlikely due to small molecule status.
- Market competition: Entry of next-generation kinase inhibitors may pressurize prices.
- Pricing policies: Increasing emphasis on value-based pricing could impact revenue.
Projected Price Stability
- Base case: Maintain current retail price of $11,000/month through 2025.
- Slight decline predicted: 2%-3% annually, driven by payer pressure and potential biosimilar entry in adjacent markets.
- Price adjustments due to inflation, manufacturing costs, or updated reimbursement policies are expected to stay within a 1%-2% range annually.
Revenue Outlook (2023-2027)
| Year |
Estimated Global Sales |
Key Drivers |
Price Adjustment |
| 2023 |
$820 million |
Stable patent, steady adoption |
0%-1% increase |
| 2024 |
$835 million |
Budgets tightening, price sensitivity |
0%-1% increase |
| 2025 |
$850 million |
Patent expiry approaches, biosimilar threat |
0%-2% decrease |
| 2026 |
$820 million |
Biosimilar entry, competition |
2%-3% decrease |
| 2027 |
$800 million |
Market saturation reaches maximum |
2%-3% decrease |
Key Risks and Opportunities
- Risks:
- Patent expiration reduces pricing power.
- Clinical trial outcomes may expand or restrict indications.
- Regulatory changes influence reimbursement policies.
- Opportunities:
- New formulations (e.g., combination therapy) may command premium pricing.
- Expansion into emerging markets could increase sales volume.
- Companion diagnostics could improve cost-effectiveness and support higher prices.
Summary
Stivarga (regorafenib) commands a high market share in metastatic colorectal cancer, GIST, and HCC treatments. Its price is established at approximately $11,000/month in the U.S., with global variations. Market dynamics suggest stable pricing through 2024, followed by potential declines driven by patent expiry and increased competition. Revenue projections indicate gradual erosion unless new indications, formulations, or market expansion are achieved.
Key Takeaways
- The current price of NDC 57664-0690 is approximately $11,000/month in the U.S.
- Patents extend until at least 2025; biosimilars are unlikely soon.
- Market growth remains steady but faces pressure from generics and competitive therapies.
- Facing patent expiry, prices are projected to decline 2%-3% annually starting in 2025.
- Expansion into emerging markets and new indications may offset some price erosion.
FAQs
1. How does the patent status affect future pricing for NDC 57664-0690?
Patent exclusivity supports high pricing; expiration in 2025 likely will lead to price reductions due to biosimilar or generic competition.
2. Are there any approved biosimilars for regorafenib?
No. Biosimilars are not available for regorafenib because it is a small-molecule kinase inhibitor, making biosimilar development less feasible.
3. How do international reimbursement policies impact pricing?
Pricing is significantly lower outside the U.S., often due to negotiated rebates and price controls, impacting global revenue projections.
4. What competitive therapies could influence the market?
Lenvatinib and cabozantinib are key competitors that could erode market share, especially if they demonstrate superior efficacy or safety profiles.
5. Can regulatory changes alter the pricing trajectory?
Yes. Reimbursement policies, value-based pricing models, and approval of complementary diagnostics can influence revenue and pricing strategies.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2012). FDA approval for Stivarga.
[3] Bayer. (2022). Stivarga product information.
[4] EvaluatePharma. (2022). World Market Forecasts.
[5] CMS. (2022). Reimbursement policies for oncology drugs.
