Last updated: February 27, 2026
What is NDC 16571-0134?
NDC 16571-0134 corresponds to Lenvatinib mesylate (brand name: Lenvima). It is an oral tyrosine kinase inhibitor approved for thyroid cancer, hepatocellular carcinoma, renal cell carcinoma, and endometrial carcinoma. Its primary indication involves targeted therapy in oncology.
Market Size and Trends
Current Market Environment
- The global oncology drug market exceeded USD 160 billion in 2022, with targeted therapies representing a significant segment.
- Lenvatinib's primary competitors include sorafenib, cabozantinib, and other kinase inhibitors.
- In 2022, the global sales of Lenvatinib approximated USD 1.2 billion, driven by high-volume indications such as thyroid and liver cancers.
Market Drivers
- Rising prevalence of thyroid, liver, and kidney cancers.
- Growing adoption of targeted therapies.
- Expansion into additional indications, including combination regimens.
- Increased approval in Asian markets (notably China and Japan).
Market Challenges
- Competition from alternative TKIs.
- Patent expirations in some jurisdictions.
- Pricing pressures from payers, especially in Europe and the US.
Regulatory and Market Access Status
| Region |
Approval Status |
Key Regulatory Milestones |
| US |
Approved since 2015 |
FDA approval for thyroid and liver cancers |
| Europe |
Approved since 2017 |
EMA approval for thyroid carcinoma |
| Japan |
Approved since 2014 |
PMDA approval for multiple indications |
| China |
Approved since 2018 |
NMPA approval for hepatocellular carcinoma |
Price Trends and Projections
Current Pricing Overview
- The average wholesale price (AWP) for Lenvatinib in the US: USD 11,000 – USD 13,000 per month (per 4 mg capsule).
- Typically, a treatment course (~12 months) costs USD 132,000 – USD 156,000.
Pricing Factors
- Market access negotiations influence net prices.
- Price discounts through specialty pharmacies and reimbursement agreements.
- In emerging markets, prices tend to be 50-70% lower than US levels.
Price Projection Assumptions
- The US list price remains stable or marginally decreases due to payer pressure.
- International prices may decline by 5-10% annually as generic competition emerges and biosimilars are considered or as pricing negotiations tighten.
- Potential new indications or combination therapies could increase demand, supporting price stability or slight increases.
| Year |
US List Price (Per 30-day supply) |
Global Average Price (USD) |
Comments |
| 2023 |
USD 12,000 |
USD 8,000 – 10,000 |
Stable, with potential minor reductions |
| 2025 |
USD 11,500 |
USD 7,000 – 9,500 |
Competitive pressures and market expansion |
| 2027 |
USD 11,000 |
USD 6,500 – 9,000 |
Biosimilar competition, negotiating stronger |
Potential Impact of Biosimilars and Generics
- Patent expiry anticipated around 2027-2028 in the US.
- Biosimilars or generic versions could reduce prices by 20-50%.
- Price erosion could accelerate with regulatory and market entry of biosimilars, likely decreasing US list prices to USD 8,000 – USD 10,000 per month by 2028.
Key Market Opportunities and Risks
Opportunities
- Expansion into additional tumor types or combination regimens.
- Increased penetration in Asian markets.
- Price optimization through value-based agreements.
Risks
- Regulatory delays or rejections for new indications.
- Market erosion from biosimilars.
- Pricing constraints driven by healthcare policy reforms.
Key Takeaways
- The global market for Lenvatinib is currently valued around USD 1.2 billion, with steady growth driven by expanded indications and regional expansion.
- US list prices are approximately USD 12,000 per month; international prices are lower and may decline gradually.
- Patent expiries and biosimilar entry around 2027-2028 could significantly reduce prices.
- Demand stabilization or growth depends on approval of new indications and successful market penetration in key regions like Asia.
- Pricing strategies will need to adapt to regulatory, competitive, and payer pressures.
FAQs
Q1: What are the main competitors of NDC 16571-0134?
Sorafenib, cabozantinib, and other kinase inhibitors.
Q2: How soon could biosimilars impact pricing?
Biosimilar entry is expected around 2027-2028 in the US, potentially reducing prices by up to half.
Q3: What factors influence Lenvatinib's price in different markets?
Regulatory approvals, negotiation power of payers, regional healthcare policies, and competition.
Q4: Are new indications likely to sustain or increase prices?
Yes, if approved, new indications and combination therapies can increase demand, supporting sustained or higher prices.
Q5: What is the outlook for price declines in mature markets?
Prices are expected to decrease gradually, especially post-patent expiry, due to biosimilar competition and payer negotiations.
References
- U.S. Food and Drug Administration. (2015). Lenvatinib Approval Summary. [Online].
- European Medicines Agency. (2017). Lenvatinib (Lenvima): Summary of Product Characteristics.
- IQVIA. (2022). Global Oncology Market Review.
- Pharmacoeconomics & Outcomes News. (2023). Oncology drug price trends.
- IQVIA. (2023). Biosimilar market forecasts and patent expiry projections.
Note: Pricing data are indicative; actual prices vary by payer, region, and negotiated discounts.
