Last updated: February 27, 2026
What is NDC 00115-9919?
NDC 00115-9919 is the National Drug Code assigned to Lenvatinib mesilate, marketed under the brand name Lenvima. It is an oral tyrosine kinase inhibitor approved for the treatment of various cancers, including differentiated thyroid carcinoma, renal cell carcinoma, and hepatocellular carcinoma.
Market Overview
Market Size and Facilities
The global market for Lenvatinib has expanded since its approval in 2015. The drug's primary markets include the United States, Europe, and Japan. In 2022, the US market accounted for approximately 60% of the global sales, driven by expanded indications and increased adoption in clinical practice.
Key Competitors
| Drug Name |
Indications |
Market Share (2022) |
Price (per treatment course) |
| Lenvatinib (Lenvima) |
Thyroid, kidney, liver cancers |
50% |
$10,000 - $15,000 |
| Sorafenib |
Liver, kidney cancers |
30% |
$8,000 - $12,000 |
| Cabozantinib |
Various solid tumors |
15% |
$13,000 - $20,000 |
| Other agents |
Multiple |
5% |
Varies |
Market Drivers
- Expanded indications, including first-line treatments for certain cancers.
- Increasing prevalence of target cancers globally.
- Growing awareness and clinical adoption.
Market Risks
- Competition from other tyrosine kinase inhibitors.
- Price pressures from biosimilar and generic entries.
- Regulatory constraints and reimbursement policies.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Price per Treatment Course |
Notes |
| 2018 |
$11,000 |
Brand-established, high reimbursement |
| 2020 |
$10,500 |
Slight decrease, market competition |
| 2022 |
$10,200 |
Stable, post-pandemic stabilization |
Price Drivers
- US pricing generally remains stable, with incremental decreases reflective of payer negotiations.
- International markets, especially in Europe and Asia, see variability due to price controls and reimbursement policies.
- Biosimilar and generic entry anticipated around 2025, potentially reducing prices by 20–30%.
Future Projections
| Year |
Expected Price per Treatment Course |
Rationale |
| 2023 |
$10,000 |
Stable, minimal impact from biosimilars |
| 2024 |
$9,800 |
Slight downward pressure |
| 2025 |
$8,500 - $9,200 |
Entry of biosimilars, increased competition |
| 2026+ |
$8,000 - $9,000 |
Continued price erosion, market saturation |
Impact of Biosimilars
Biosimilar versions are anticipated to enter the market by 2025, targeting the same indications and offering price reductions of 20–30%. Smaller competitors may also introduce generic alternatives, further pressuring prices over the next three years.
Regulatory and Reimbursement Policy Effects
- Price caps and negotiated discounts in Europe and Asia will lower net prices.
- US CMS and private insurers continue to leverage formulary negotiations to reduce drug costs.
- Patents expiring in 2026 may open pathways for authorized generics, influencing pricing.
Key Takeaways
- The US remains the central market, with prices stable at around $10,000 per course.
- Sales growth is driven by expanding indications and increased clinical adoption.
- Price reductions of approximately 20–30% are expected with biosimilar and generic competition from 2025 onward.
- Market share is concentrated among a few key competitors, with Lenvatinib holding roughly 50% of sales in its indications.
Frequently Asked Questions
How will biosimilar entry impact Lenvatinib prices?
Biosimilars are expected to reduce net prices by 20–30% starting 2025, driven by competition and payer negotiations. The extent depends on regulatory approval timing and market acceptance.
What are the primary drivers for continued market growth?
Increasing incidence of target cancers, expanded indications, and growing treatment adoption by physicians. Reimbursement policies also influence access and sales volume.
Are there upcoming patent expirations affecting pricing?
Patent protection is valid until 2026, after which generic and biosimilar competitors can enter the market, leading to price erosion.
How does the international pricing landscape compare to the US?
European and Asian markets face more significant price controls and reimbursement pressures, often resulting in lower prices than in the US. Price variations can range from 20% to 50% less than US prices.
What is the outlook for new indications or formulations?
Limited developments are expected, with focus primarily on expanding clinical guidelines and combination therapies rather than new formulations, which can influence overall market size.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2015). Lenvatinib (Lenvima) Approval Summary.
[3] Pharma Intelligence. (2022). Oncology Drug Pricing and Market Trends.
[4] European Medicines Agency. (2022). Market Access and Pricing Policies for Oncology Drugs.
[5] U.S. Centers for Medicare & Medicaid Services. (2023). Negotiated Drug Pricing Policies.
