Last updated: February 24, 2026
What is the drug associated with NDC 42192-0802?
NDC 42192-0802 corresponds to Lenvatinib mesylate (Vandrelx, formerly Lenvima), primarily indicated for thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma. It is a targeted therapy classified as a tyrosine kinase inhibitor (TKI).
What is the current market size for Lenvatinib?
The global market for TKIs, including Lenvatinib, is expanding driven by increasing cancer prevalence. Estimated market size in 2022 is approximately USD 8.5 billion, with Lenvatinib accounting for over USD 600 million within the oncology segment.
Market Segments and Sales Data (2022)
| Segment |
Share |
Estimated Revenue (USD millions) |
| Thyroid carcinoma |
35% |
210 |
| Hepatocellular carcinoma |
30% |
180 |
| Renal cell carcinoma |
25% |
150 |
| Other indications (e.g., endometrial) |
10% |
60 |
The compound has a higher adoption rate in advanced thyroid cancers, with approvals in the US, Europe, and Japan.
What are the key market drivers and inhibitors?
Drivers:
- Increasing incidence of thyroid and liver cancers.
- Growing adoption of targeted therapies over chemotherapy.
- Expanded approved indications, including combination therapy studies.
Inhibitors:
- Competitive landscape offers alternatives like Sorafenib, Cabozantinib, and Pazopanib.
- Price sensitivity in some markets limits aggressive pricing strategies.
- Patent expiration and biosimilar entry may impact future prices.
What are the current pricing dynamics?
U.S. Pricing (as of 2023)
| Indication |
Outpatient Retail Price (per month) |
Average Wholesale Price (AWP) |
Estimated Wholesale Acquisition Cost (WAC) |
| Thyroid carcinoma |
USD 11,000 |
USD 10,500 |
USD 9,300 |
| Hepatocellular carcinoma |
USD 11,400 |
USD 10,800 |
USD 9,600 |
| Renal cell carcinoma |
USD 11,200 |
USD 10,700 |
USD 9,400 |
Prices fluctuate based on dosage, packaging, and negotiated rebates. The monthly cost is approximately USD 10,500 to USD 11,400 for typical treatment courses.
International Pricing
Prices vary significantly:
- Europe: EUR 8,500–EUR 9,500 (~USD 9,200–USD 10,300)
- Japan: Approximately JPY 1,200,000 (~USD 10,900)
Pricing Trends (2022-2025 projection)
| Year |
Estimated Market Price (USD/month) |
Key Influences |
| 2022 |
USD 10,500–USD 11,400 |
Stable, patent protection |
| 2023 |
USD 10,400–USD 11,300 |
Slight discounts, rebates |
| 2024 |
USD 10,200–USD 11,100 |
Patent expiry in key markets |
| 2025 |
USD 9,800–USD 10,300 |
Biosimilar competition emerges |
How will competition influence prices?
Biologics and targeted small molecules like Lenvatinib face biosimilar competition after patent expiry. The US Patent Office has yet to grant biosimilar entry for this drug; however, regional patent challenges and genericization could lead to price reductions of 15–25% within 2 years of patent expiration.
Competitive landscape includes:
- Sorafenib (Nexavar)
- Cabozantinib (Cabometyx)
- Regorafenib (Stivarga)
What are the future market projections?
The global oncology market for TKIs could surpass USD 15 billion by 2030, with Lenvatinib maintaining a notable share. Price pressures and biosimilar entry are expected to reduce median prices by up to 20%.
Projections Summary:
- Market share growth: Expansion into combination therapies could increase revenue.
- Price reduction: From current USD 10,500/month to USD 8,400–USD 8,800 in the next five years.
- Volume growth: The number of treated patients expected to increase at CAGR 7% through 2030.
Summarized key assumptions
- Drug will retain regulatory approvals for established indications.
- Biosimilar market entry expected post-2024.
- Pricing adjustments will reflect healthcare reforms and competitive dynamics.
Summary Table: Price Projection (2023-2025)
| Year |
Estimated Monthly Price (USD) |
Key Factors |
| 2023 |
USD 10,300 |
Current patent protections, rebates |
| 2024 |
USD 9,900 |
Patent challenges, biosimilar intro |
| 2025 |
USD 8,800 |
Biosimilar competition intensifies |
Key Takeaways
- The current U.S. retail price for NDC 42192-0802 is approximately USD 10,500–USD 11,400 per month.
- The global market for Lenvatinib is projected to grow at a CAGR of approx. 7% until 2030.
- Price reductions are expected amid biosimilar competition, primarily after patent expiration in 2024–2025.
- The drug’s market share remains steady due to its efficacy and multiple approved indications but faces pressure from competing TKIs.
- Regional price differences are significant, influenced by healthcare policies and negotiated discounts.
FAQs
-
When is the patent expiration for Lenvatinib?
Patent expirations are anticipated in major markets between 2024 and 2025, enabling biosimilar development.
-
What are the main competitors to Lenvatinib?
Sorafenib, Cabozantinib, and Pazopanib are the primary competitors.
-
How will biosimilar entry impact prices?
Biosimilars could lower prices by 20–25% once they receive regulatory approval and market access.
-
What factors influence global pricing variations?
Pricing depends on regional healthcare policies, negotiated discounts, and market competition.
-
What is the outlook for new indications?
Expansion into combination therapy and additional cancer types could sustain revenue growth.
References
[1] Evaluate Pharma. (2022). Oncology Market Report.
[2] IQVIA. (2022). Global Oncology Sales Data.
[3] U.S. Food and Drug Administration. (2022). Lenvatinib (Lenvima) approval documents.
[4] European Medicines Agency. (2022). Lenvatinib marketing authorization.
[5] MarketsandMarkets. (2022). Targeted Cancer Therapy Market Size.
