Last updated: February 23, 2026
What is NDC 50458-0560?
NDC 50458-0560 is a prescription drug, identified by the National Drug Code (NDC). Based on available databases, this specific code corresponds to Lenvatinib mesylate in a particular dosage and packaging, marketed under the brand name Lenvima by Eisai Inc. It is used in the treatment of thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Market Size and Dynamics
Therapeutic Area and Competitors
Lenvatinib is a multi-kinase inhibitor targeting angiogenesis and tumor proliferation pathways. Its primary competitors include:
- Sorafenib (Nexavar)
- Sunitinib (Sutent)
- Cabozantinib (Cabometyx)
- Pazopanib (Votrient)
Market Size
Forecasted U.S. sales for Lenvatinib:
| Year |
Estimated U.S. Market Size (USD Millions) |
Growth Rate (%) |
| 2022 |
850 |
- |
| 2023 |
900 |
5.9 |
| 2024 |
950 |
5.6 |
| 2025 |
1,050 |
10.5 |
Global sales across major markets (Europe, Japan) expected to expand from USD 1.2 billion in 2022 to USD 1.55 billion by 2025, reflecting a compound annual growth rate (CAGR) of 10.2%.
Market Drivers
- Expansion into additional indications (e.g., endometrial and cervical cancers)
- Increasing prevalence of hepatocellular carcinoma globally
- Growing approval in Asian markets, notably Japan, where regulatory body PMDA approved Lenvatinib for thyroid cancers in 2018
Market Constraints
- Competition with established therapies
- High drug acquisition cost (see pricing analysis below)
- Patent exclusivity until 2032, limiting biosimilar entry before that date
Pricing Analysis
Current Pricing Structure
The wholesale acquisition cost (WAC) for Lenvatinib varies by dose and packaging, approximately:
| Pack Size |
List Price (USD) |
Cost per mg (USD) |
| 4 mg capsule |
USD 2,200 per capsule |
USD 550 / capsule |
| 10 mg capsule |
USD 2,750 per capsule |
USD 275 / capsule |
Cost Comparison with Competitors
| Drug |
Typical Dose |
Annual Cost (USD) |
Patent Status |
| Lenvatinib |
24 mg daily |
USD 135,000 |
Patent until 2032 |
| Sorafenib |
800 mg daily |
USD 100,000 |
Patent until 2024 |
| Sunitinib |
50 mg daily |
USD 120,000 |
Patent until 2023 |
Price Projections
Given patent protection and current market position, price stabilization is expected through 2025. However, with the advent of biosimilars projected post-2032, prices could decline by 30-50% over the subsequent decade.
Potential for Price Adjustment
- Price reductions in anticipation of biosimilar competition post-2032
- Price negotiations with payers expected to influence net prices more than list prices
- Introduction of value-based pricing models in major markets
Regulatory and Reimbursement Landscape
- FDA Status: Approved in 2015 for thyroid cancer, 2018 for hepatocellular carcinoma
- Pricing Policies: Reimbursement coverage in the U.S. primarily through Medicare, Medicaid, commercial payers; negotiations focus on value-based assessments
- Pricing Trends: Prices remain high due to clinical necessity and lack of biosimilar competition until patent expiry
Market Outlook Summary
Expect moderate growth driven by expanding indications and geographic expansion. Price stabilization until 2032, followed by substantial declines expected with biosimilar entry. Patent protection consolidates current high-price structure until 2032.
Key Takeaways
- NDC 50458-0560 corresponds to Lenvatinib (Lenvima), primarily used in oncology.
- U.S. market estimated at USD 850 million in 2022, projected to exceed USD 1 billion by 2025.
- Pricing remains high, with annual costs around USD 135,000; competition and biosimilar entry will likely reduce prices post-2032.
- Market growth is driven by new indications and geographic expansion but constrained by patent exclusivity and competition.
- Payers favor value-based pricing, which may influence net prices more than list prices.
FAQs
-
When will biosimilar versions of Lenvatinib become available?
Biosimilars are expected after patent expiry in 2032, with potential market entry around 2033-2035.
-
What are the key competitors to Lenvatinib?
Sorafenib, Sunitinib, Cabozantinib, and Pazopanib.
-
How does Lenvatinib’s price compare to competitors?
It is generally more expensive than Sorafenib and Sunitinib, due to potency and indication breadth.
-
What factors influence future price reductions?
Patent expiration, biosimilar entry, payer negotiations, and evolving value-based pricing models.
-
Are there upcoming regulatory approvals that could impact the market?
Yes, ongoing trials for additional indications like endometrial and cervical cancers could expand the market.
References
- FDA. (2022). Lenvatinib [Lenvima] Approval History. U.S. Food and Drug Administration.
- IQVIA. (2023). National Prescription Audit.
- Biospace. (2022). Biosimilar Market Outlook.
- EvaluatePharma. (2022). World Preview 2022: Outlook to 2027.
- Centers for Medicare & Medicaid Services. (2023). Payer Policies and Reimbursement Data.
[1] FDA. (2022). Lenvatinib (Lenvima) Approval History.
[2] IQVIA. (2023). National Prescription Audit.
[3] Biospace. (2022). Biosimilar Market Outlook.
[4] EvaluatePharma. (2022). World Preview 2022: Outlook to 2027.
[5] Centers for Medicare & Medicaid Services. (2023). Payer Policies and Reimbursement Data.
