Last updated: April 5, 2026
What is the drug associated with NDC 60505-6146?
NDC 60505-6146 identifies Lenvatinib Mesylate, marketed under the brand name Lenvima. It is a tyrosine kinase inhibitor approved for the treatment of various cancers including thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma.
Market Overview
Commercial Landscape
- Indications: Lenvatinib's primary approved uses cover differentiated thyroid carcinoma, hepatocellular carcinoma, renal cell carcinoma, and certain endometrial cancers.
- Market Players: Prime competitors include sorafenib, sunitinib, pazopanib, and cabozantinib.
- Market Size (2022): Estimated global sales of Lenvatinib approximated $1.2 billion, with North America accounting for roughly 60%.
Regulatory and Patent Status
- Patent Expirations: Patent protection originally extended to 2025; patent litigation and exclusivity periods may influence market entry.
- Regulatory Approvals: Initially approved by FDA in 2015; indications expanded post-approval, influencing sales dynamics.
Key Market Drivers
- Incidence of targeted cancers is rising globally.
- Growing awareness and acceptance of oral targeted therapies.
- Expansion of indication approvals.
Market Challenges
- High treatment costs.
- Competitive landscape with established TKIs.
- Patent challenges and biosimilar development.
Price Projections (2023-2028)
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately $11,820 per 30-count, 4 mg tablets (~$295 per tablet).
- Per Treatment Course: Varies by indication and dosage; average treatment course ranges from 3 to 6 months.
Projected Trends
| Year |
Estimated Wholesale Price (per 30-count) |
Key Factors |
| 2023 |
$11,820 |
Current pricing; high cost due to innovation. |
| 2024 |
$11,200 – $12,000 |
Slight price decrease anticipated with patent challenges and biosimilar entry. |
| 2025 |
$10,500 – $11,500 |
Possible price reductions due to biosimilar approvals and increased competition. |
| 2026 |
$9,800 – $11,000 |
Market stabilization; biosimilars gain market share. |
| 2027 |
$9,200 – $10,500 |
Continued biosimilar penetration; pricing pressure persists. |
| 2028 |
$8,500 – $10,000 |
Further biosimilar entry; potential for price stabilization at lower levels. |
Influencing Factors
- Biosimilar Development: Biosimilar versions expected to enter the market by 2025-2026, exerting downward pressure on prices.
- Market Penetration: Increased adoption in combination therapies could maintain higher prices.
- Reimbursement Policies: Changes in insurance strategies and payer negotiations may influence net prices.
- Regulatory Changes: Additional indications or expanded approvals may temporarily increase demand and price points.
Competitive and Market Share Analysis
| Competitor |
Market Share (2022) |
Indications |
Price Range (per month) |
| Sorafenib (Nexavar) |
30% |
Liver, renal, thyroid cancers |
~$10,300 |
| Sunitinib (Sutent) |
25% |
Renal, gastrointestinal tumors |
~$10,700 |
| Pazopanib (Votrient) |
15% |
Renal, soft tissue sarcoma |
~$8,800 |
| Cabozantinib (Cabometyx) |
10% |
Renal, liver, thyroid cancers |
~$12,000 |
| Lenvatinib (Lenvima) |
20% |
Thyroid, liver, renal |
~$11,800 |
Key Takeaways
- The global market for Lenvatinib is mature, with a current value near $1.2 billion.
- Price projections indicate a gradual decline driven by biosimilar competition and market saturation.
- Patent expiry and biosimilar approvals forecast significant price reductions starting in 2025.
- Continued innovation and expanded indications could sustain higher prices temporarily.
- Competition from other TKIs remains stiff, influencing pricing strategies and market share.
FAQs
1. When are biosimilars for Lenvatinib expected to be approved?
Expected approvals are around 2025-2026, considering development timelines and regulatory review periods.
2. How does biosimilar competition impact pricing?
Biosimilar entry typically causes a 20-40% decrease in list prices, depending on market conditions and adoption rates.
3. What are the primary indications for Lenvatinib that influence its market?
Differentiated thyroid carcinoma, hepatocellular carcinoma, renal cell carcinoma, and some endometrial cancers.
4. How does Lenvatinib's price compare with other TKIs?
It is priced similarly to sunitinib and cabozantinib, generally between $10,000 and $12,000 per month.
5. Are there upcoming regulatory changes that could influence market dynamics?
Potential approval of new indications and biosimilar competitors could reshape the competitive landscape and pricing.
Sources:
[1] IQVIA. (2022). Global Oncology Market Data.
[2] U.S. Food and Drug Administration. (2015). Lenvatinib (Lenvima) approval documentation.
[3] Evaluated price listings from Red Book and CMS pricing databases.
[4] Market research reports from MedTrack and EvaluatePharma.
