Last updated: February 17, 2026
What Is NDC 51407-0032?
NDC 51407-0032 identifies Lenvatinib (Lenvima), a kinase inhibitor marketed by Eisai, primarily used to treat thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma. Approved by the FDA in 2015, it has expanded indications, including endometrial carcinoma and other solid tumors under accelerated approval pathways.
Market Overview
Market Size and Growth
- The global oncology drug market approaches $200 billion annually, with targeted therapies like Lenvatinib representing a significant segment.
- Lenvatinib's sales reached approximately $1.3 billion in 2022, with a compound annual growth rate (CAGR) of approximately 23% since 2018, driven by increased indications and ongoing clinical trials.
Competitive Landscape
- Key competitors include Sorafenib (Nexavar), Cabozantinib (Cabometyx), and Regorafenib (Stivarga).
- Lenvatinib differentiates with its efficacy in multiple tumor types and favorable side-effect profile, but pricing pressure persists due to biosimilars and generics entering some markets.
Pricing Trends and Projections
Current Pricing
- The average wholesale price (AWP) in the U.S. for Lenvatinib (per 4 mg tablet) is approximately $124.
- Monthly treatment cost ranges from $12,000 to $15,000, depending on dosing and insurance coverage.
- The list price for a 28-day supply (based on typical dosing of 24 mg daily) is approximately $35,000–$40,000.
Price Drivers
- Patent exclusivity until 2030 provides pricing stability.
- Increasing adoption for additional indications expands the market.
- Biosimilar and generic competition is minimal currently, supporting higher prices.
Future Price Projections (2023–2028)
| Year |
Expected Average Wholesale Price (AWP) |
Key Factors |
| 2023 |
~$125 per 4 mg tablet |
Stable patent protection, steady demand |
| 2024 |
~$127 per 4 mg tablet |
Slight inflation adjustments, clinical trial approvals |
| 2025 |
~$130 per 4 mg tablet |
Potential early biosimilar entry in select markets |
| 2026 |
~$132 per 4 mg tablet |
Market expansion, new indication approvals |
| 2027 |
~$135 per 4 mg tablet |
Patent expiry approaches in some regions; price stabilization |
| 2028 |
~$137 per 4 mg tablet |
Biosimilar market entry, price competition begins |
Market Opportunities and Risks
Opportunities
- Additional indications, including lung and gastric cancers.
- Expanded geographical approvals in Europe, Asia, and emerging markets.
- Combination therapies that improve efficacy could lead to increased demand.
Risks
- Patent expiration and biosimilar development could pressure prices.
- Development of new targeted therapies with better efficacy or safety profiles.
- Regulatory restrictions or unfavorable reimbursement policies.
Key Takeaways
- NDC 51407-0032 corresponds to Lenvatinib, a key drug in targeted oncology therapy with a sales trajectory exceeding $1.3 billion in recent years.
- The drug's market growth hinges on expanding indications, geographic expansion, and minimal current biosimilar competition.
- Price projections suggest modest increases aligned with inflation and market expansion, though biosimilar entries could destabilize pricing approaching 2027–2028.
- Patent protection remains until 2030, supporting current premium pricing.
- Market risks include biosimilar competition and evolving regulatory landscapes.
FAQs
1. How does the price of Lenvatinib compare globally?
Prices vary significantly; in Europe, prices are approximately 20–30% less due to pricing regulation, whereas in emerging markets, costs can be substantially lower.
2. What are the main drivers of Lenvatinib sales growth?
Expansion of approved indications, increased global approvals, and ongoing clinical trials bolster demand.
3. When will biosimilar competition likely impact pricing?
Biosimilars could enter the market between 2025 and 2027, depending on patent litigation and regulatory approvals.
4. Are there significant regulatory hurdles for expanding Lenvatinib indications?
Yes. Additional approvals require clinical evidence demonstrating safety and efficacy, which involves time and investment.
5. What is the outlook for Lenvatinib in combination therapies?
Combining Lenvatinib with immune checkpoint inhibitors like pembrolizumab shows promise, potentially expanding usage and boosting long-term revenues.
References
- IQVIA. "Global Oncology Market Analysis," 2022.
- FDA. Lenvatinib (Lenvima) Approval and Indications, 2015–2022.
- EvaluatePharma. "Oncology Drug Sales Data," 2022.
- IMS Health. "Pharmaceutical Price Trends," 2023.
- MarketWatch. "Biosimilar Launches and Patent Expirations," 2023.
