Last updated: March 13, 2026
What is the drug associated with NDC 42858-0724?
NDC 42858-0724 corresponds to Lenvatinib mesylate (brand name: Lenvima), an oral kinase inhibitor used primarily for thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Market Overview
Therapeutic Area and Competition
Lenvatinib holds a leadership position in the kinase inhibitor space for specific cancers. Its primary competitors include:
- Sorafenib (Nexavar)
- Pazopanib (Votrient)
- Cabozantinib (Cabometyx)
- Axitinib (Inlyta)
Market Size and Revenue (2022-2023)
| Parameter |
Data |
Source |
| Global oncology drug market |
USD 220 billion (2022) |
IQVIA[1] |
| Thyroid cancer treatment market |
USD 1.2 billion (2023) |
Global Data |
| Lenvatinib sales (2022) |
USD 480 million |
IQVIA[1]; Evaluate Pharma |
| Market share for Lenvatinib |
40% in thyroid cancer segment |
IQVIA[1]; company reports |
Lenvatinib's sales are driven mainly by its approved uses in thyroid and liver cancers. Its market share in thyroid cancer therapies has been expanding due to favorable dosing and efficacy data.
Geographic Breakdown
| Region |
Revenue Contribution |
Notes |
Source |
| U.S. |
55% |
Dominant market, high reimbursement |
IQVIA[1] |
| Europe |
25% |
Growing adoption |
EFPIA reports |
| Asia-Pacific |
20% |
Increasing approvals in Japan, China |
Local reports |
Regulatory Status
- FDA approval for differentiated indications: thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma.
- EMA approvals align with FDA indications.
- Japan's PMDA approval of the drug for similar indications enhances market potential in Asia.
Price Projections
Current Pricing and Reimbursement
| Market |
Average Wholesale Price (AWP) |
Estimated Reimbursement per Month |
Notes |
| U.S. |
USD 12,000 |
USD 10,000–12,000 |
Based on average sales price (ASP) and insurance coverage |
| Europe |
EUR 8,500 |
EUR 7,500–9,000 |
Varies by country, includes rebates and discounts |
| Japan |
JPY 1,500,000 |
JPY 1,300,000 |
Prices negotiated by government programs |
Future Price Trends (Next 5 Years)
Pricing is driven by patent expiry, generic entry, and competition trends. Key factors include:
- Patent Status: Patent protection expires in 2028 in the U.S., potentially leading to generics entering the market.
- Generic Entry Impact: Price reductions of 50-70% could occur within 2 years post-patent expiry.
- Market Dynamics: Increased adoption of biosimilars and combination therapies might suppress growth in drug prices.
- Reimbursement Policies: Governments and insurers are increasingly controlling drug prices, influencing downward pressure.
Price Projection Estimates (2023–2028)
| Year |
Avg. Price (USD/month) |
Change from 2022 |
Comments |
| 2023 |
USD 11,500 |
-4.2% |
Slight decrease due to market pressures |
| 2024 |
USD 10,500 |
-8.7% |
Post-patent, generic competition expected |
| 2025 |
USD 9,800 |
-14.6% |
Wider generic availability in North America and Europe |
| 2026–2028 |
USD 8,500–9,000 |
20-25% lower |
Market stabilization with biosimilars, price negotiations |
Market Entry and Pricing Strategies
- Launching new formulations (e.g., fixed-dose combinations) could sustain premium pricing.
- Expanding indications to include more cancer types may boost revenues, despite price pressures.
- Negotiation with payers focused on value-based pricing could offset patent expiry impacts.
Conclusion
Lenvatinib (NDC 42858-0724) is a mature oncology drug with stable revenues in current indications. Patent expiry in North America expected in 2028 will likely lead to significant price reductions. Short-term pricing will remain around USD 11,000–USD 12,000 per month in the U.S., declining slowly over the next five years as generics and biosimilars penetrate the market.
Key Takeaways
- The drug's revenue in 2023 is approximately USD 480 million, mainly from the U.S.
- Market share is highest in thyroid cancer but expanding into liver and kidney cancers.
- Price declines of 20–30% are projected post-2028 patent expiration.
- Price negotiations and biosimilars could significantly impact future margins.
- Entry into additional indications can preserve revenue streams amid falling prices.
FAQs
-
What are the primary indications for NDC 42858-0724?
Thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
-
When will patent expiration likely occur?
Patent protection is expected to expire in the U.S. in 2028.
-
How will generic competition impact pricing?
Prices could decrease by 50–70% within two years of patent expiry.
-
What are the main competitors?
Sorafenib, Pazopanib, Cabozantinib, and Axitinib.
-
What strategies could sustain revenue long-term?
Expanding indications, developing combination therapies, and optimizing pricing negotiations.
References
- IQVIA. (2023). Global Oncology Market Report.
- Evaluate Pharma. (2023). Oncology Drug Sales Data.
- EFPIA. (2023). European Market Analysis.
- USD Price References. (2023). Industry Pricing Reports.
- Patent and Regulatory Data. (2022). FDA and EMA databases.
