Last updated: March 9, 2026
What is NDC 67457-0196?
NDC 67457-0196 is a specific drug product identified via the National Drug Code (NDC) system. According to available databases, this NDC corresponds to Lenvatinib Mesylate (brand name: Lenvima). It is approved by the FDA for the treatment of differentiated thyroid carcinoma, hepatocellular carcinoma, renal cell carcinoma, and other indications.
Market Overview
Historical Sales Data
Lenvatinib's sales have increased steadily over recent years:
| Year |
Estimated US Sales (USD millions) |
Notes |
| 2020 |
950 |
Increased adoption across indications |
| 2021 |
1,200 |
Expanded approval for additional cancer types |
| 2022 |
1,350 |
Entry into new markets, slight growth |
Key Drivers
- Expanded indications: Approval for additional cancer types increases patient pool.
- Market penetration: Increasing adoption in oncology clinics.
- Pricing strategies: Premium pricing maintained for targeted oncology therapies with limited competition.
Competitive Landscape
Major competitors include:
| Drug Name |
Mechanism |
Approximate 2022 US Sales |
Indications |
| Sorafenib |
Kinase inhibitor |
$950 million |
Hepatocellular carcinoma, renal cell carcinoma |
| Regorafenib |
Kinase inhibitor |
$600 million |
Gastrointestinal stromal tumors, hepatocellular carcinoma |
| Cabozantinib |
Tyrosine kinase inhibitor |
$1 billion |
Kidney and liver cancers |
Lenvatinib's sales account for approximately 30-40% of frontline kinase inhibitor sales in its primary indications.
Current Market Position
Lenvatinib holds a significant share in the frontline treatment space for hepatocellular carcinoma and thyroid cancers. It is considered a preferred agent due to its efficacy profile and dosing convenience.
Price Projections
Current Pricing
Gross Wholesale Acquisition Cost (WAC):
| Formulation & Pack |
Price per Dose (USD) |
Monthly Cost (USD) |
Notes |
| 4 mg capsules |
$100 |
$3,000 |
Based on average wholesale prices |
| 10 mg capsules |
$250 |
$7,500 |
Higher-dose formulations available |
Average Treatment Costs:
- In the US, the average monthly cost for Lenvatinib treatment ranges between $7,000 and $8,000, depending on dosage adjustments and insurance coverage.
Price Projection Assumptions
- Market penetration growth: 3-5% annually driven by expanded indications.
- Price stability: Slight increases (~2% annually) due to inflation and capped pricing strategies.
- Competitive pressure: Moderate, with no major generics expected before 2025.
5-Year Revenue Forecast
| Year |
Projected US Sales (USD millions) |
Assumptions |
| 2023 |
1,500 |
Continued market share growth, stable pricing |
| 2024 |
1,575 |
Slight price increase, increased adoption |
| 2025 |
1,650 |
Approaching patent expiry, potential biosimilar threat |
| 2026 |
1,600 |
Biosimilar entry begins, price competition increases |
| 2027 |
1,550 |
Market saturation, price reductions |
Patent and Regulatory Landscape
- Patent protection extends until approximately 2025, with potential for biosimilar competition beginning thereafter.
- The FDA approved Lenvatinib in 2015; regulatory flexibility for extension based on new indications or formulations is limited.
Market Entry and Development Risks
- Patent expiry poses substantial generic and biosimilar competition risks.
- New combinations or formulations could introduce competition or expand market share.
- Regulatory delays or adverse outcomes could impact pricing and sales.
Key Takeaways
- The drug's US market sales are growing modestly, with an average annual revenue near $1.5 billion.
- Pricing remains stable but faces potential downward pressure with biosimilar entry post-2025.
- The outlook hinges on continued indication approvals and market access expansion.
- Patent expiration marks a pivotal transition point, likely reducing prices significantly.
FAQs
-
What are the primary indications for NDC 67457-0196?
Lenvatinib is approved for differentiated thyroid carcinoma, hepatocellular carcinoma, renal cell carcinoma, and certain endometrial cancers.
-
When is patent expiration projected?
Patent protection is expected to expire around 2025, after which biosimilars may enter the market.
-
How does the drug compare with competitors in pricing?
Pricing is comparable to similar kinase inhibitors, with treatment costs averaging $7,000–$8,000 monthly.
-
What factors could influence future sales?
Additional indications, regulatory changes, competition from biosimilars, and pricing adjustments.
-
What is the forecast for biosimilar entry?
Biosimilars are likely to launch between 2025 and 2027, leading to increased competition and price reduction.
References
[1] FDA Drug Database. (2023). Lenvatinib (Lenvima). https://www.accessdata.fda.gov
[2] IQVIA. (2022). US Oncology Market Reports.
[3] EvaluatePharma. (2022). World Market Outlook for Oncology Drugs.
[4] Medicare & Medicaid Services. (2023). Drug Utilization Data.
[5] PatentScope. (2022). Lenvatinib patent filings and expirations.
