Last updated: February 20, 2026
What is NDC 45802-0490?
NDC 45802-0490 corresponds to Lenvatinib mesylate, marketed under the brand name Lenvima. Approved by the FDA for thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma, Lenvatinib is an oral tyrosine kinase inhibitor used primarily in oncology.
Market Landscape
Therapeutic Area and Market Size
Lenvatinib operates within the cancer therapy segment, competing with drugs like sorafenib, cabozantinib, and pazopanib. The global oncology drug market, valued at approximately USD 200 billion in 2022, shows increased demand for targeted therapies.
Market Drivers
- Rising incidence of thyroid, liver, and kidney cancers.
- Adoption of targeted therapy and precision medicine.
- Approval of expanded indications, including combination therapies.
Competitive Environment
| Drug Name |
Indication |
Annual Sales (2022) |
Market Share (2022) |
| Lenvatinib (Lenvima) |
Thyroid, liver, kidney cancers |
USD 1.2 billion |
12% |
| Sorafenib |
Liver, kidney, thyroid cancers |
USD 0.9 billion |
9% |
| Cabozantinib |
Medullary thyroid, kidney, liver |
USD 0.8 billion |
8% |
| Pazopanib |
Kidney, soft tissue sarcoma |
USD 0.6 billion |
6% |
Market Trends
- Increasing approval for new combinations with immunotherapies.
- Growing use in earlier-line therapies.
- Expansion into additional indications under clinical trials.
Price Projections
Current Pricing
Wholesale acquisition cost (WAC) for Lenvatinib averages around USD 13,000 per month (2023). Insurance and pharmacy discounts reduce net prices.
| Price Element |
Cost |
| WAC |
USD 13,000/month |
| Average net price |
USD 10,000/month (after discounts) |
Projected Pricing Trends (2023-2028)
| Year |
Expected WAC |
Expected Net Price |
Rationale |
| 2023 |
USD 13,000 |
USD 10,000 |
Stable pricing; steady demand |
| 2024 |
USD 13,200 |
USD 10,200 |
Slight inflation, demand growth |
| 2025 |
USD 13,400 |
USD 10,400 |
Slight price increases, competition pressures |
| 2026 |
USD 13,600 |
USD 10,600 |
Introduction of biosimilars or generics (if approved) |
| 2027 |
USD 14,000 |
USD 11,000 |
Market adjustments, potential new indications |
| 2028 |
USD 14,500 |
USD 11,500 |
Continued inflation, expanded use |
Price Drivers
- Entry of biosimilar or generic versions could reduce prices by 20-30% within 3–5 years.
- Increased adoption in combination therapies may support higher pricing or volume.
- Regulatory decisions influencing label expansions can impact demand and prices.
Revenue Projections
Assuming a conservative annual volume growth of 8% and current net price, revenues could evolve as follows:
| Year |
Estimated Patient Treatments |
Total Revenue (USD billions) |
| 2023 |
10,000 |
USD 1.2 |
| 2024 |
10,800 |
USD 1.3 |
| 2025 |
11,664 |
USD 1.4 |
| 2026 |
12,597 |
USD 1.5 |
| 2027 |
13,605 |
USD 1.6 |
| 2028 |
14,693 |
USD 1.7 |
Note: These figures depend heavily on market penetration, payer policies, and competition.
Regulatory and Patent Outlook
- Patent expiration anticipated around 2028, potentially opening the market to generics.
- Ongoing clinical trials may extend patent exclusivity through new indications or formulations.
- Regulatory decisions on combination therapies can influence market size.
Key Takeaways
- Lenvatinib maintains a relevant share in the targeted cancer therapy market, with consistent revenue projections.
- Market growth is driven by increasing cancer incidences and expanding indications.
- Price stability is expected through 2025, with potential for decreases post-patent expiry.
- Competition from biosimilars and generics could significantly impact prices and market share.
- Monitoring regulatory developments related to label expansion and new indications remains essential.
FAQs
1. How will patent expiration impact the market for NDC 45802-0490?
Patent expiration around 2028 could enable biosimilar versions, leading to price reductions of 20–30% and increased competition.
2. Are there upcoming indications that could boost demand?
Yes, clinical trials are exploring combinations with immunotherapies and expanding into additional cancers, which could increase usage.
3. How does price compare to similar drugs?
Lenvatinib's current net monthly price (~USD 10,000) is comparable to sorafenib and cabozantinib, with slight variations based on insurance rebates and discounts.
4. What are the primary factors influencing future prices?
Market penetration, competition from biosimilars, regulatory approvals, and demand for combination therapies.
5. How significant is the impact of biosimilar competition?
Biosimilars could reduce prices by 20–30%, potentially eroding profit margins and market share for the branded drug within 3–5 years.
References
[1] IQVIA. (2023). Global Oncology Market Data.
[2] FDA. (2021). Lenvatinib (Lenvima) approval documents.
[3] EvaluatePharma. (2022). Oncology drug market report.
