Last updated: February 25, 2026
What is the Drug Associated with NDC 51407-0833?
NDC 51407-0833 corresponds to Lenvatinib Mesylate (Lenvima), a kinase inhibitor approved for the treatment of radioactive iodine-refractory differentiated thyroid cancer, renal cell carcinoma, and hepatocellular carcinoma.
Market Size and Competitive Landscape
Therapeutic Area Reach
| Indication |
Estimated 2023 Market Value |
Competitors |
| Radioactive iodine-refractory thyroid cancer |
$500 million |
Sorafenib, Pazopanib, Cabozantinib, Sorafenib |
| Renal cell carcinoma |
$4 billion |
Sunitinib, Pazopanib, Axitinib, Cabozantinib |
| Hepatocellular carcinoma |
$3.2 billion |
Sorafenib, Regorafenib, Cabozantinib |
Market Dynamics
- Lenvatinib's global sales reached approximately $1.8 billion in 2022.
- Growth driven by expanded approvals, including for endometrial carcinoma since 2019.
- Dominates in thyroid cancer where alternatives are limited; competitive pressure increases in renal and liver indications.
Key Factors Influencing Market and Pricing
Regulatory Approvals & Expansions
- FDA approved Lenvatinib in 2015.
- Expand indications in 2019 for endometrial carcinoma.
- European approvals followed in 2016 and 2020 for additional indications.
Pricing Trends
| Year |
Approximate Wholesale Price (per 4 mg dose) |
Notes |
| 2015 |
$12,500 |
Initial launch price |
| 2019 |
$12,000 |
Slight decrease in response to competition |
| 2023 |
$11,700 |
Continued slight decline, influenced by biosimilars and price negotiations |
Reimbursement & Payer Dynamics
- Commercial payers reimburse at approximately $11,700 per month (average wholesale price).
- Medicaid and Medicare reimburse at negotiated rates, often lower by 10-15%.
- Price erosion partly driven by biosimilar competition in related drug classes, though no biosimilar for Lenvatinib has launched yet.
Price Projection through 2028
| Year |
Estimated Price (per 4 mg dose) |
Key Drivers |
| 2024 |
~$11,500 |
Market stabilization, slight competitive pressures |
| 2025 |
~$11,300 |
Entry of biosimilar runoff, negotiation intensifies |
| 2026 |
~$11,000 |
Price pressures, increased generic-like competition |
| 2027 |
~$10,700 |
Further market penetration, pricing negotiations |
| 2028 |
~$10,500 |
Market saturation, biosimilar influence continues |
Forecast based on current trends suggests annual price declines of 1%–2%, influenced by market share shifts and generic pressure, although actual generic or biosimilar entries for Lenvatinib are unlikely in the near term.
Market Entry and Patent Timeline
| Year |
Key Event |
Notes |
| 2015 |
FDA approval for hepatocellular carcinoma |
Launch phase |
| 2018 |
Patent expiration for initial formulation in the U.S. |
Patent expiration expected in 2030 |
| 2023+ |
Possible biosimilar entry? |
No biosimilars launched yet; patent holdings are critical |
Commercial and Strategic Implications
- Continued revenue growth in existing indications hinges on extending approval bases.
- Price competition is limited due to lack of biosimilars.
- Future growth depends on market penetration, line extensions, and combination therapies.
Regulatory and Policy Environment
- Patent litigation remains active in some jurisdictions.
- Price control measures emerging in Europe and some U.S. states could influence revenue.
- Clinical trial results and new indications could stabilize or increase pricing power.
Summary
Lenvatinib (NDC 51407-0833) maintains a significant position within targeted oncology markets. While current pricing remains relatively stable, it faces an environment of gradual price erosion driven by competitive pressures and policy shifts. Sales are expected to grow modestly over the next five years owing to expanded indications, with gradual price declines reflecting market maturation.
Key Takeaways
- The drug generated around $1.8 billion in 2022, dominating several oncology indications.
- Price per unit has decreased marginally from $12,500 in 2015 to approximately $11,700 in 2023.
- Market growth depends heavily on approved indications and clinical outcomes.
- Biosimilar entry for Lenvatinib remains unlikely before 2030, keeping prices relatively stable.
- Future revenue depends on clinical trial success, regulatory approvals, and policy landscapes.
FAQs
1. Is there potential for price increases for Lenvatinib in the next five years?
Unlikely, due to market saturation, biosimilar threats, and policy pressure driving prices downward.
2. What are the main competitors to Lenvatinib?
Sorafenib, Pazopanib, Cabozantinib, and Sunitinib are key competitors across different indications.
3. How does regulation affect future price projections?
Pricing may be influenced by drug reimbursement policies, patent litigation, and potential biosimilar approvals.
4. When is biosimilar entry expected for Lenvatinib?
As of 2023, no biosimilar is approved. Patent expiration is anticipated around 2030, after which biosimilar entry could occur.
5. What factors could disrupt current market trends?
Breakthroughs in alternative therapies, regulatory changes, or significant clinical trial failures could alter forecasted growth and prices.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- FDA. (2015). Lenvatinib (Lenvima) Approval Announcement.
- EvaluatePharma. (2023). 2023 World Market Outlook.
- CMS. (2022). Reimbursement Rates for Oncology Drugs.
- European Medicines Agency. (2020). Lenvatinib Approval Status.
