Last updated: March 9, 2026
What Is NDC 65162-0228?
NDC 65162-0228 identifies a specific drug product registered in the United States. This NDC (National Drug Code) corresponds to Lenvatinib Mesylate, marketed under the brand name Lenvima. Approved by the FDA in 2015, Lenvatinib is a tyrosine kinase inhibitor used primarily to treat thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Market Overview
Current Market Size
The global market for kinase inhibitors, including Lenvatinib, reached approximately USD 7.8 billion in 2022. The U.S. accounts for over 40% of this figure, making it the dominant regional market.
In the United States, sales of Lenvatinib (Lenvima) in 2022 totaled approximately USD 1.2 billion, driven by its approved indications and expanding label.
Key Market Drivers
- Expansion of Indications: Additional approvals for different cancer types, including endometrial carcinoma, increased the number of eligible patients.
- Growing Prevalence: Increasing incidence rates of thyroid, liver, and kidney cancers sustain demand.
- Combination Therapy Approvals: Use with pembrolizumab for endometrial carcinoma in 2021 expanded treatment options.
- Pricing Strategy: Premium pricing remains justified by efficacy and limited competition.
Competitive Landscape
Major competitors include:
- Sorafenib (Nexavar): Approved for liver and kidney cancers; USD 500 million in U.S. sales (2022).
- Sunitinib (Sutent): Broad anti-cancer activity; USD 600 million in U.S. sales.
- Cabozantinib (Cabometyx): Recently gained approvals; USD 900 million in 2022.
- Regorafenib (Stivarga): Approval for several cancers; sales approximate USD 400 million.
Market share distribution in the US (2022):
| Drug |
Estimated Market Share |
Sales (USD millions) |
| Lenvatinib |
20% |
USD 240 |
| Sorafenib |
15% |
USD 180 |
| Sunitinib |
20% |
USD 240 |
| Cabozantinib |
25% |
USD 300 |
Price Analysis and Projections
Current List Price
The average wholesale price (AWP) for Lenvatinib in the U.S. is approximately USD 17,000 per month per patient. This translates to an annual treatment cost of roughly USD 204,000.
Cost Factors Influencing Price
- Patent Protections: Patent protection delays biosimilar entry until 2027.
- Market Exclusivity: Data exclusivity until 2025 sustains premium pricing.
- Manufacturing Costs: Estimated at 10-15% of retail price, influenced by raw materials and manufacturing scale.
- Reimbursement Dynamics: Coverage varies by payer, affecting net pricing.
Price Trajectory
- 2023-2025: Prices are expected to remain stable, with minimal downward pressure due to lack of biosimilar competition.
- Post-2025: Entry of biosimilars could reduce prices by 20%-40% over the subsequent 2-3 years.
- Long-term: Assuming patent expiry in 2027, multiple biosimilar entries could further lower prices, with estimates showing potential reductions to USD 10,000-12,000 per month.
Forecast Summary
| Year |
Estimated Average Monthly Price |
Expected Licensing or Biosimilar Entry |
Notes |
| 2023 |
USD 17,000 |
No biosimilars |
Patent protection in effect |
| 2024 |
USD 17,000 |
No biosimilars |
Reinforces value argument |
| 2025 |
USD 16,500 |
Biosimilar filings expected |
Data exclusivity expires |
| 2026 |
USD 15,000 |
Biosimilar market debut |
Price competition intensifies |
| 2027+ |
USD 12,000 |
Multiple biosimilars enter |
Price erosion stabilizes at lower levels |
Regulatory and Policy Impacts
- FDA Approvals: Expansion of indications can support higher pricing temporarily.
- Pricing Regulations: CMS and commercial payers increasingly enforce negotiations.
- Biosimilar Entry: EMA and FDA approval pathways open avenues for cost competition.
Key Opportunities and Risks
- Opportunities: Market expansion through new indications; combination therapies; partnerships for biosimilar development.
- Risks: Patent challenges; biosimilar competition; pricing caps in public markets.
Key Takeaways
- NDC 65162-0228 (Lenvatinib) is a high-revenue drug with limited near-term competition.
- Current annual treatment prices approximate USD 204,000.
- Market share in the US is around 20%, totaling USD 240 million in sales.
- Price reductions are expected post-2025 due to biosimilar entry, with projections indicating a decrease to USD 12,000/month by 2027.
- Expansion of indications and combination therapies are primary growth drivers.
FAQs
Q1: When will biosimilars for Lenvatinib likely enter the market?
A1: Biosimilar approval is expected around 2027, following patent expiry and regulatory processes.
Q2: How will biosimilar competition affect pricing?
A2: Biosimilars could reduce prices by 20%-40%, potentially lowering treatment costs to USD 10,000-12,000 per month.
Q3: What are the primary growth areas for Lenvatinib?
A3: Expansion into additional cancer indications and use in combination therapies, especially with immune checkpoint inhibitors.
Q4: Are there legal challenges affecting patent protections?
A4: Patent litigations are common; some may threaten exclusivity but currently, protections extend to 2027.
Q5: How does current reimbursement influence market dynamics?
A5: Reimbursement levels affect net pricing and access, with payers increasingly leveraging negotiations for discounts.
References
[1] IQVIA. (2023). Pharmaceutical Market Reports.
[2] FDA. (2022). Drug Approvals and Indications.
[3] EvaluatePharma. (2023). Global Oncology Market Analysis.
[4] U.S. Patent and Trademark Office. (2022). Patent Status for Lenvatinib.
[5] CMS.gov. (2023). Reimbursement Policies for Oncology Drugs.
