Last updated: February 23, 2026
What is NDC 16571-0173?
NDC 16571-0173 refers to Lenvatinib mesilate 4 mg tablets, marketed as Lenvima. It is an oral tyrosine kinase inhibitor approved for treating thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Market Size and Demand Drivers
Indications and Market Penetration
- Thyroid cancer: Approved since 2015, captures a niche but growing cohort due to rising incidence.
- Hepatocellular carcinoma (HCC): Approved in 2018; HCC globally affects over 800,000 annually, amplifying demand.
- Renal cell carcinoma: Approved in 2019; worldwide RCC cases approximate 403,000 per year (GLOBOCAN, 2020).
Competitive Landscape
- Competes with agents like sorafenib, cabozantinib, and axitinib.
- Market share is influenced by efficacy, side effect profiles, and regulatory approvals.
Sales Data (2021-2022)
| Year |
Estimated Global Sales (USD Millions) |
Comments |
| 2021 |
450 |
Steady growth amid COVID-19 disruptions |
| 2022 |
510 |
Post-pandemic recovery, expanded indications |
Growth Drivers
- Increasing prevalence of targeted therapies.
- Expanding approval in additional markets.
- Introduction of generic versions may impact revenue.
Price Analysis
Current Pricing
- List price per 4 mg tablet (U.S.): Approximately USD 80–120.
- Estimated annual wholesale cost per patient: USD 11,520–USD 17,280, assuming 120 tablets per year.
Pricing Trends
- Brand name: Maintains premium pricing amid limited generic competition.
- Post-patent expiry: Expect price erosion of 30-50%, leading to potential USD 4,000–8,500 per patient annually.
Regulatory and Policy Impact
- Price negotiations vary by country, influencing net costs.
- Policies promoting biosimilars and generics likely to reduce prices over 3–5 years.
Price Projections (Next 3–5 Years)
| Year |
Estimated Price Range (USD per tablet) |
Assumptions |
| 2023 |
80–120 |
Stable brand pricing, limited generic entries |
| 2024–2025 |
50–90 |
Entry of generics in multiple markets, price competition |
| 2026–2028 |
30–70 |
Broader biosimilar availability, stricter cost controls |
Revenue Impact
- Current annual global sales valued at USD 510 million.
- Price downward pressure could lower revenues by 20–40% if generic penetration accelerates.
Factors Influencing Market and Prices
- Patent status: Patents expire in late 2025 in the U.S., enabling generics.
- Regulatory approvals: Additional indications in emerging markets expand market size.
- Insurance coverage: Reimbursement policies affect out-of-pocket costs and market access.
Key Takeaways
- NDC 16571-0173 (Lenvatinib) commands high prices driven by efficacy and limited competition.
- Market size expands with new indications and geographic penetration.
- Post-patent expiry, prices are expected to decline significantly due to generic entry.
- Total revenue remains vulnerable to biosimilar and generic competition, especially after 2025.
- Price erosion could reduce annual revenues by up to 40% over the next five years.
FAQs
1. When will generics enter the market for NDC 16571-0173?
Patent protection in the U.S. expires in late 2025, enabling generics to enter within a year or two thereafter.
2. How will biosimilars influence prices?
Though biosimilars are less common for small molecules like lenvatinib, generic versions will likely lead to steeper price reductions, especially in regulated markets.
3. What are the primary drivers for market growth?
Increasing incidence of target cancers, regulatory approvals of new indications, and expanding geographic access.
4. How do insurance policies impact pricing?
Reimbursement policies and formulary placements influence net prices and access, especially in healthcare systems with strict cost controls.
5. What markets will have the fastest price declines?
The U.S. and Europe, due to early patent expiries and robust biosimilar markets, will see the largest price reductions in the coming years.
References
[1] GLOBOCAN 2020. International Agency for Research on Cancer. "Globocan 2020: Cancer Burden Data."
[2] IQVIA. 2022 Pharmaceutical Sales Data.
[3] US Food and Drug Administration. Lenvatinib approval and patent status.
