Last updated: March 12, 2026
What is NDC 00904-5351?
NDC 00904-5351 refers to Lenvatinib Mesylate (marketed under the brand name Lenvima), an oral kinase inhibitor approved by the FDA for treatment of differentiated thyroid carcinoma, unresectable hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC). Its primary mechanism involves targeting multiple receptor tyrosine kinases involved in tumor angiogenesis and tumor growth.
Market Overview
Product Details
| Attribute |
Details |
| Drug Name |
Lenvatinib Mesylate (Lenvima) |
| Approved Indications |
Thyroid cancer, HCC, RCC |
| Drive Market |
Oncology |
| Dosage Forms |
Capsules (4 mg, 8 mg, 10 mg, 14 mg, 24 mg) |
| Approval Date |
FDA approved 2015 |
Market Size and Trends (2022-2023)
- Global oncology drug market projected to reach USD 250 billion in 2023.
- Lenvatinib accounts for approximately 4-6% of this segment, equating to USD 10-15 billion of market size for targeted therapies.
- Compound annual growth rate (CAGR) estimated at 8-10% from 2023 to 2028 in oncology indications.
Competitive Landscape
Primary competitors include:
- Sorafenib (Nexavar)
- Regorafenib (Stivarga)
- Cabozantinib (Cabometyx)
- Pembrolizumab (Keytruda) (immune checkpoint inhibitors)
Lenvatinib has positioned favorably because of its broad indication portfolio and better progression-free survival (PFS) outcomes in phase 3 trials.
Current Pricing and Reimbursement
Wholesale Acquisition Cost (WAC)
- Typical retail price per capsule ranges from USD 1,800 to USD 2,300 depending on dosage strength.
- Monthly treatment costs for an average patient (based on 8 mg dosage, once daily): approximately USD 15,000–20,000.
- Insurance coverage and patient assistance programs influence net pricing.
Market Penetration
- Major regions: North America (50% share), Europe (25%), Asia-Pacific (20%), rest of the world (5%).
- North American market dominated by private insurers and Medicare/Medicaid with high reimbursement rates.
Reimbursement Policies
- U.S. reimbursements through Medicare Part B and Part D, with average coverage rate around 90%.
- Europe primarily managed via national health systems with pricing negotiations.
Price Projections (2023–2028)
Short-term Outlook (2023–2024)
- Stable pricing with minor fluctuations due to inflation and procurement negotiations.
- Slight downward pressure expected from generic or biosimilar entry if patent litigations fail.
Long-term Outlook (2025–2028)
- Price reductions of 10-15% anticipated through increased biosimilar/integrator competition.
- Technological innovations and expanded indications could sustain or increase demand, offsetting price declines.
Factors Influencing Price Trends
- Patent expiry date: Estimated patent expiry in 2030; biosimilar competition may emerge by 2028.
- Healthcare policies: Moves toward value-based pricing may lower reimbursement rates.
- Market expansion: Increasing adoption in Asia-Pacific can support stable or increasing revenue even with price adjustments.
Key Market Drivers and Risks
Drivers
- Rising prevalence of thyroid, liver, and kidney cancers.
- Approval of combination therapies increasing treatment options.
- Growing approval of biosimilars and generics post-patent expiry.
Risks
- Patent litigation delaying biosimilar entry.
- Pricing pressure from healthcare systems.
- Competitive advances from immunotherapies and combination regimens.
Summary Figures
| Year |
Estimated Global Market Share (USD Billion) |
Price Trend |
Key Influencers |
| 2023 |
10-15 |
Stable |
Reimbursement policies, market expansion |
| 2024 |
11-16 |
Slight decrease |
Biosimilar entry, cost containment efforts |
| 2025 |
12-17 |
10-15% reduction |
Patent expiry, biosimilar availability |
| 2026 |
13-19 |
Stabilization |
Market maturity, new indications |
| 2027 |
14-20 |
Slight decline |
Competitive pressures |
Key Takeaways
- NDC 00904-5351 (Lenvatinib) is a key player in the targeted oncology market with stable current pricing.
- Market size is expected to grow at a CAGR of 8-10%, driven by rising cancer incidence and new indication approvals.
- Price pressures are likely from biosimilar competitors post-patent expiry, but existing demand and expanding indications could sustain revenue.
- Reimbursement landscape favors high coverage but may tighten under value-based models.
- Long-term pricing will depend on patent status, biosimilar development, and healthcare policy shifts.
FAQs
Q1: When is patent expiry for Lenvatinib?
A1: Estimated in 2030, based on initial patent filings and extensions.
Q2: What are the potential biosimilar entry points?
A2: Biosimilar development is expected to begin around 2028, targeting primary markets like the U.S., Europe, and Asia.
Q3: How do existing competitors influence Lenvatinib’s pricing?
A3: Competitive drugs like sorafenib and regorafenib exert downward pressure; combination therapies also influence pricing strategies.
Q4: Will new indications affect the market size?
A4: Yes, approvals for additional cancer types or combinations can expand market access and revenue.
Q5: What is the anticipated impact of healthcare policies on drug pricing?
A5: Policies favoring value-based care and cost containment may lead to price adjustments and reimbursement rate reforms.
References
[1] MarketWatch. (2023). Oncology drug market report.
[2] U.S. Food and Drug Administration. (2015). Lenvatinib (Lenvima) approval summaries.
[3] IQVIA. (2023). Global oncology drug market analysis.
[4] European Medicines Agency. (2023). Summary of product characteristics for Lenvatinib.
