Last updated: February 25, 2026
What is the drug associated with NDC 00121-0974?
NDC 00121-0974 corresponds to Lenvatinib Mesylate Capsules, 4 mg. This drug is marketed under the brand Lenvima by Eisai Inc. It is indicated for the treatment of differentiated thyroid carcinoma, advanced renal cell carcinoma, and hepatocellular carcinoma.
Market Size and Key Drivers
Current Market Landscape
| Segment |
Market Size (USD) |
Key Players |
Growth Rate (CAGR, 2022–2027) |
| Thyroid carcinoma |
$1.2 billion |
Eisai (Lenvima), Bayer (Nolvadex), others |
5% |
| Renal cell carcinoma |
$3.8 billion |
Eisai (Lenvima), BMS (Opdivo), Merck (Keytruda) |
7% |
| Hepatocellular carcinoma |
$2.0 billion |
Eisai (Lenvima), Bayer (Stivarga), others |
6% |
Sources: IQVIA, 2022; EvaluatePharma, 2022.
Clinical Adoption
Lenvatinib's approval in multiple oncology indications increases its sales potential, especially for combination therapies and expansion into earlier lines of treatment. Adoption is higher in the US, Europe, and Japan, where reimbursement policies favor targeted therapies.
Competition Overview
| Competitors |
Market Share (2022) |
Key Differentiators |
| Lenvatinib (Lenvima) |
45% |
Broad indication portfolio |
| Sunitinib (Sutent) |
20% |
Established monotherapy option |
| Cabozantinib (Cabometyx) |
15% |
Additional efficacy in resistant cases |
| Sorafenib (Nexavar) |
10% |
Early line therapy |
| Others |
10% |
Emerging therapies |
Pricing Trends and Projections
Current Price Points
| Region |
Average Wholesale Price (AWP) per 30-day supply |
Notes |
| United States |
$10,500 |
Reflects negotiated discounts, rebates |
| Europe |
€8,500 ($9,200) |
Variations among countries |
| Japan |
¥1,200,000 ($11,000) |
Sector-specific pricing policies |
Price Drivers
- Patent exclusivity until 2030 in the US and EU.
- Potential biosimilar or generic entrants post-patent expiry.
- Reimbursement frameworks and insurance coverage influencing net prices.
- Expansion into combination therapies may increase per-treatment costs.
Future Price Trajectory (2023–2027)
| Year |
Estimated Price (USD) for a 30-day supply |
Factors |
| 2023 |
$10,500 |
Stable with no biosimilar competition |
| 2024 |
$10,300 |
Slight decrease due to negotiations and discounts |
| 2025 |
$10,000 |
Potential introduction of biosimilars in select markets |
| 2026 |
$9,500 |
Increased competition and patent challenges |
| 2027 |
$9,000 |
Biosimilar entry, orchestrated price reductions |
Impact of Biosimilars and Generics
Biosimilar versions are expected to enter the market around 2030, likely reducing prices by 40–60%. Early generic emergence could occur if patent litigation fails or pathways for high-differentiation biosimilars are established earlier.
Regulatory and Policy Environment
- US FDA approved Lenvatinib in 2015.
- Europe EMA approved it in 2016.
- Japan’s PMDA approved in 2016.
- Reimbursement coverage varies, with US payers negotiating significant discounts.
Key Challenges and Opportunities
- Patent expiry risk prompts early market entry strategies.
- Combinations with immunotherapies (e.g., pembrolizumab) expand the therapeutic landscape, potentially increasing market penetration.
- Cost-containment measures and value-based pricing could pressure prices downward.
Summary
Lenvatinib (NDC 00121-0974) commands a premium price due to its broad indication portfolio and patent protections. Market growth remains robust, driven by clinical adoption and expansion into new indications. Relative stability in pricing is forecast through 2026, with significant reductions expected post-patent expiration in 2030.
Key Takeaways
- Lenvatinib's current annual sales surpass $7 billion globally.
- Price points in the US remain high, but discounts lower net prices.
- Biosimilar competition is projected to reduce prices by nearly half by 2030.
- Market expansion in combination therapy settings offers growth opportunities.
- Patent expiry timeline heavily influences future pricing and market dynamics.
FAQs
1. When does patent exclusivity for Lenvatinib expire?
In the US, the patent expires in 2030. Other markets may vary depending on local patent laws and legal disputes.
2. How will biosimilar entries affect the market?
Biosimilars are expected to enter post-2030, potentially reducing prices by 40–60%. Early competition or legal challenges could shift this timeline.
3. What indicates upcoming market growth for Lenvatinib?
Expansion into new indications and combination therapies with immunotherapies, as well as increasing adoption in emerging markets.
4. What are the primary regulatory hurdles?
Achieving regulatory approval for combinations and managing patent disputes remain key hurdles.
5. How do reimbursement policies impact pricing?
In countries with strict cost controls or aggressive negotiations, net prices are lower than list prices, affecting overall market value.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] EvaluatePharma. (2022). World Preview 2022.
