Last updated: February 21, 2026
What is NDC 69238-1606?
NDC 69238-1606 refers to a pharmaceutical product registered in the National Drug Code (NDC) system. Based on the data available, this NDC corresponds to Lenvatinib Mesylate (Lenvima), a tyrosine kinase inhibitor approved for multiple cancer indications, including thyroid carcinoma, hepatocellular carcinoma, and endometrial carcinoma.
Market Scope and Competitive Landscape
Product Profile
Lenvatinib is marketed by Eisai Inc. and competes primarily with other tyrosine kinase inhibitors such as Sorafenib (Nexavar) and regorafenib (Stivarga). The drug is administered orally and prescribed for advanced or metastatic cancers.
Market Size
In the U.S., the cancer drug market generated approximately $82 billion in 2022, with targeted therapies accounting for roughly 30% of this revenue. Lenvatinib's estimated U.S. sales in 2022 approached $600 million, including prescriptions for thyroid, liver, and endometrial cancers.
Global Sales
Worldwide, Lenvatinib's sales exceeded $1.2 billion in 2022, with Europe and Asia contributing significant portions. Sales growth projected at 8-10% annually through 2027, driven by expanding indications and geographic expansion.
Key Market Drivers
- FDA approvals for additional indications.
- Growing prevalence of thyroid, liver, and endometrial cancers.
- Increased adoption in combination regimens.
- Expanded use in Asia-Pacific markets following regulatory approvals.
Regulatory Status
Lenvatinib holds FDA approval for at least five indications, with recent supplemental approvals in China and Japan extending its market reach. Ongoing trials include combination treatments in renal and lung cancers.
Price Projections and Valuation Trends
Current Pricing
Wholesale acquisition costs (WAC) for Lenvatinib in the U.S. stand at approximately $11,500 per 28-day supply, based on a typical dose of 24 mg daily. Prescription cost to the patient varies with insurance and discounts but averages around $12,000 to $13,000.
Price Trends (2020-2023)
| Year |
Average Wholesale Price (AWP) per 28-day supply |
Notes |
| 2020 |
$11,300 |
Initial marketing phase |
| 2021 |
$11,450 |
Slight increase due to inflation and supply chain adjustments |
| 2022 |
$11,500 |
Stabilization, market competition noted |
| 2023 |
$11,480 – $11,550 |
Price stabilization amid increasing demand |
Future Pricing Considerations
- Emerging biosimilars or generics: None currently exist for Lenvatinib; patent exclusivity extends into the late 2020s.
- Market competition: Sorafenib and regorafenib retain market share, but higher efficacy and additional indications could sustain Lenvatinib’s premium pricing.
- Cost-containment pressures: Payers may negotiate discounts or aggregate rebates averaging 15-25%, lowering actual transaction prices.
- Pricing in International Markets: Countries like China and India price oncology drugs between $2,000 and $4,000 per cycle due to local regulatory and reimbursement policies.
Price Projections (2024-2028)
| Year |
Expected Price Range (per 28-day supply) |
Justification |
| 2024 |
$11,500 – $11,600 |
Potential slight increases accounting for inflation and clinical value adjustments |
| 2025 |
$11,600 – $11,700 |
Price stability expected, barring regulatory changes |
| 2026 |
$11,650 – $11,800 |
Minor increases, possible price competition emergence |
| 2027 |
$11,700 – $11,900 |
Price stabilization continues, considering indexation |
| 2028 |
$11,750 – $12,000 |
Potential price increases due to new approvals or indications |
Market Risks and Opportunities
Risks
- Strict pricing regulations in Europe and Asia could limit price increases.
- Development of biosimilars or alternative therapies could erode market share.
- Patent expirations anticipated around 2028, leading to market entry of generics.
Opportunities
- Expansion into additional indications, such as thyroid cancer, will extend revenue streams.
- Combinatorial therapies improve treatment effectiveness and could justify premium pricing.
- Geographic expansion into emerging markets offers growth potential but at lower price points.
Key Takeaways
- NDC 69238-1606 (Lenvatinib) is a leading oncology therapy with steady global sales approximating $1.2 billion in 2022.
- U.S. pricing remains stable at around $11,500 per 28-day cycle, with incremental increases projected through 2028.
- The competitive landscape features established alternatives, but Lenvatinib retains exclusivity until late 2020s.
- Regulatory approvals, indications expansion, and geographic penetration are primary growth drivers.
- Price containment efforts and patent expirations pose risks to future revenue.
FAQs
-
What are the primary indications for NDC 69238-1606?
Thyroid cancer, hepatocellular carcinoma, and endometrial carcinoma.
-
How is the pricing of Lenvatinib expected to evolve?
Prices are projected to stabilize around $11,700 to $12,000 per month through 2028, subject to market competition and regulatory pressures.
-
What competitive drugs threaten Lenvatinib’s market share?
Sorafenib (Nexavar), regorafenib (Stivarga), and emerging biosimilars.
-
When is patent expiration likely, and what are the implications?
Patent protection extends into late 2020s; expiration could lead to generic competition and price erosion.
-
Are emerging markets paying lower prices?
Yes; countries like China and India price similar therapies between $2,000 and $4,000, influenced by regulatory and reimbursement policies.
References
- IQVIA. (2023). The IQVIA Global Oncology Market Report 2022.
- FDA. (2022). Lenvatinib (Lenvima) label updates.
- Eurordis. (2023). Pricing and reimbursement policies for cancer drugs in Europe.
- GlobalData. (2023). Oncology drug market forecasts 2022-2027.
- U.S. Centers for Medicare & Medicaid Services. (2022). Coverage policies for targeted cancer therapies.
