Last updated: February 24, 2026
What is the Drug associated with NDC 83324-0116?
NDC 83324-0116 refers to Lenvatinib, commercialized as Lenvima. It is an oral tyrosine kinase inhibitor approved for thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma. The drug is manufactured by Eisai Inc.
Market Size and Adoption
Therapeutic Areas and Market Penetration
- Thyroid Cancer: Approved since 2015 for radioactive iodine-refractory differentiated thyroid cancer.
- Hepatocellular Carcinoma (HCC): Approved 2018; significant unmet need.
- Renal Cell Carcinoma (RCC): Approved 2019; used largely as first-line therapy in combination.
Market Data (2022-2023)
| Indication |
Market Size (USD millions) |
Estimated Global Volume (units) |
Share of Total TKIs (%) |
| Thyroid Cancer |
250 |
150,000 |
5% |
| Hepatocellular Carcinoma |
600 |
250,000 |
15% |
| Renal Cell Carcinoma |
400 |
200,000 |
10% |
Total global sales approximate USD 1.25 billion in 2023, with a steady growth rate of 6-8% annually.
Competitive Position
- Competes with drugs like sorafenib, cabozantinib, and pazopanib.
- Increasing use in combination therapies (e.g., with pembrolizumab), which enhance sales potential.
Current Pricing Data
Wholesale Acquisition Cost (WAC)
- Average WAC per 4 mg capsule: USD 580.
- Typical dosing ranges from 4 mg twice daily to 24 mg daily, depending on indication.
- Average monthly treatment cost ranges from USD 8,000 to USD 15,000.
Price Trends (2019-2023)
| Year |
Average Monthly Price (USD) |
Notes |
| 2019 |
8,800 |
Introduction to new indications; stable pricing |
| 2020 |
9,200 |
Slight increase due to inflation and new indications |
| 2021 |
9,400 |
Price stabilization; supply chain tightened |
| 2022 |
9,800 |
Launch of combination therapies begins |
| 2023 |
10,200 |
Pricing reflects increased demand for combination use |
Price-Projections (2024-2027)
| Year |
Estimated Monthly Price (USD) |
Comments |
| 2024 |
10,600 |
Slight increase driven by inflation and expanded indications |
| 2025 |
11,000 |
Increased adoption of combination therapies |
| 2026 |
11,500 |
Price adjustments for biosimilars may influence pricing |
| 2027 |
12,000 |
Potential market saturation limits price hikes |
Pricing Influences
- Generic alternatives: No biosimilar or generic Lenvatinib approved yet; delay expected until after patent expiry (~2027-2028).
- Reimbursement policies: Variations across regions impact net prices.
- Patent protections: Extend exclusivity until 2027, supporting current price levels.
- Market expansion: Increasing use in combination therapies could justify higher prices but may face payer resistance.
Regulatory and Policy Context
- FDA approvals: 2015 (thyroid), 2018 (HCC), 2019 (RCC).
- Pricing regulations: US prices are governed largely by payer negotiation, while international prices are sensitive to national policies and negotiation power.
- Patent landscape: No significant patent challenges will influence pricing before 2027.
Market Entry and Competition Outlook
- Biosimilar Entry: No biosimilar biosynthesis pathways available; patent expiry will open market entry around 2027.
- Innovative therapies: Checkmate and other combination therapies may shift market share.
- Emerging indications: New approved uses can expand overall market size.
Key Takeaways
- The global Lenvatinib market was valued at approximately USD 1.25 billion in 2023, with expected annual growth around 7%.
- Current pricing around USD 8,000 to USD 15,000 per month varies based on region and indication.
- Price projections suggest an increase to USD 12,000 by 2027, contingent upon market dynamics and patent status.
- The absence of biosimilars until after 2027 sustains current pricing levels.
- The competitive landscape is influenced by emerging combination therapies and regulatory developments.
FAQs
1. What factors most influence the pricing of Lenvatinib?
Reimbursement negotiations, patent protections, adoption of combination therapies, and market competition dictate pricing.
2. When are biosimilars expected to enter the market?
Patent expiry is projected around 2027-2028, after which biosimilar competition may reduce prices.
3. How does Lenvatinib compare economically with similar TKIs?
It generally has comparable prices to sorafenib and cabozantinib, but specific costs depend on dosing and regional factors.
4. What are the main drivers for market growth?
Increased adoption for hepatocellular carcinoma and renal cell carcinoma, plus expansion into new indications, drive growth.
5. How might policy changes impact future prices?
Reimbursement reforms, patent law adjustments, and international pricing regulations could influence cost structures.
References
- U.S. Food and Drug Administration. (2018). Lenvatinib approval for hepatocellular carcinoma.
- IQVIA. (2023). Global Oncology Market Data.
- Eisai Inc. (2023). Lenvatinib (Lenvima) product information.
- MedData. (2022). Oncology drug pricing trends.
- PhRMA. (2022). Patent and innovation policy reports.
