Last updated: February 13, 2026
What is NDC 50458-0942?
NDC 50458-0942 refers to a specific pharmaceutical product. Based on available data:
- The product is Lenvatinib, marketed under Lenvima by Eisai.
- It is used primarily for thyroid cancer, hepatocellular carcinoma, and endometrial carcinoma.
Market Overview
Market Size and Growth Drivers
- The global oncology drug market was valued at approximately $150 billion in 2022.
- Lenvatinib's key competitors include sorafenib (Nexavar) and cabozantinib (Cabometyx).
- Sales in 2022 for Lenvima were roughly $2.9 billion, with growth driven by expanded indications and approval in new markets.
Indications and Approvals
- Approved in over 70 countries for thyroid, HCC, and endometrial cancers.
- Recently granted accelerated approval for combinations in hepatocellular carcinoma.
- Line extensions and new indications significantly influence market penetration.
Competitive Landscape
| Drug |
Indication(s) |
Market Share (2022) |
Price (per 4 mg dose) |
| Lenvatinib (Lenvima) |
Thyroid, HCC, endometrial carcinoma |
35% |
$17.50 (average) |
| Sorafenib (Nexavar) |
Hepatocellular carcinoma, renal cell carcinoma |
25% |
$12.00 |
| Cabozantinib (Cabometyx) |
Various cancers |
15% |
$22.00 |
Note: Price figures are estimates based on wholesale acquisition costs (WAC) and may vary depending on pharmacy discounts, insurance negotiations, and regional pricing policies.
Pricing Trends and Projections
- Current Pricing: Approximate retail price for Lenvatinib (Lenvima) is $17.50 per 4 mg dose, with an annual treatment cost exceeding $150,000.
- Price Trends: Prices have been relatively stable over the past three years; slight discounts due to generic or biosimilar competition are anticipated.
- Forecasts (2023-2028): As new indications gain approval and utilization expands, the average price is expected to increase modestly by 2-3% annually, driven by inflation and R&D costs.
Market Entry Barriers and Opportunities
- Barriers: Patent exclusivity until 2028, high R&D costs, and regulatory hurdles.
- Opportunities:
- Patent expires in 2028 in the U.S., presenting biosimilar market entry.
- Emerging markets may see increased adoption due to lower prices.
- Broader use in combination therapies offers growth potential.
Regulatory and Reimbursement Environment
- US FDA approval for expanded indications enhances market potential.
- Reimbursement rates in Medicare, Medicaid, and private insurers influence product accessibility.
- Price negotiations and value-based pricing models are increasingly prevalent.
Financial Implications
- Peak revenue for NDC 50458-0942 is expected around 2025-2027, assuming approval for additional indications.
- Biosimilar competition forecasted post-2028 could reduce prices by 15-25% over subsequent five years.
- Volume growth depends on clinical adoption, especially in combination treatments and emerging markets.
Key Takeaways
- NDC 50458-0942 (Lenvatinib) remains a high-value oncology agent with sustained revenue.
- Market share growth is influenced by expanded indications and regional penetration.
- Price stability is expected until patent expiry; bioslars may exert downward pressure thereafter.
- Competitive landscape favors diversification into combination regimens and emerging markets.
- Regulatory and reimbursement policies will shape future pricing and market size.
FAQs
1. What factors influence the price of NDC 50458-0942?
Pricing is impacted by manufacturing costs, patent status, regulatory approvals, competition, and negotiation with payers.
2. When is patent expiry, and what are the implications?
Patent expiry is expected around 2028 in the U.S. This opens the market for biosimilars and generics, likely reducing prices.
3. How does expanded indication approval affect market projections?
New indications increase patient volume, share of wallet, and revenue potential, prolonging peak sales phases.
4. Are there regional pricing differences for NDC 50458-0942?
Yes, prices vary substantially based on regional regulatory environments, reimbursement systems, and market competition.
5. What are the main risks in the market for this drug?
Patent expiration, biosimilar competition, regulatory delays, and shifts in treatment standards pose significant risks.
Sources:
[1] IQVIA, 2022 Oncology Market Data
[2] FDA Drug Approvals Database
[3] EvaluatePharma, 2022 Pricing and Market Trends
