Last updated: March 13, 2026
What is NDC 13811-0717?
NDC 13811-0717 refers to Lenvatinib mesylate, marketed under the brand name Lenvima. It is an oral tyrosine kinase inhibitor approved for thyroid cancer, renal cell carcinoma, and hepatocellular carcinoma. Its patent expiration and biosimilar entry influence market dynamics.
Market Size and Epidemiology
Indications and Patient Population
- Thyroid Cancer: Approximately 52,000 new cases annually in the U.S. (SEER 2020)
- Renal Cell Carcinoma: Around 76,000 new cases annually (SEER 2020)
- Hepatocellular Carcinoma: 42,000 new cases annually (American Cancer Society 2021)
Market Penetration
- Lenvatinib competes with other tyrosine kinase inhibitors like Sorafenib, Cabozantinib, and Pazopanib.
- Premier drugs in indication: Sorafenib, with an annual global sales exceeding $800 million.
- Lenvatinib's market share varies across indications, roughly estimated at 25% in thyroid cancer, 15% in RCC, and increasing in hepatocellular carcinoma due to recent approvals.
Competitive Landscape
| Drug Name |
Approval Year |
Indications |
2022 Global Sales (USD Millions) |
Patent Status |
Biosimilar Entry |
| Lenvatinib (Lenvima) |
2015 |
Thyroid, RCC, HCC |
$1,200 |
Active patent until 2029 |
No |
| Sorafenib (Nexavar) |
2005 |
HCC, RCC |
$800 |
Patent expired in 2021 |
Yes (generics) |
| Regorafenib (Stivarga) |
2012 |
Colorectal, GIST |
$580 |
Patent expires 2024 |
No |
Patent landscape indicates exclusivity through 2029; biosimilar competition in the next 2-3 years expected to impact pricing.
Pricing Analysis
Current Pricing
- Average wholesale price (AWP) in the U.S.: approximately $11,000–$12,000 per month for a standard dose.
- Wholesale acquisition cost (WAC): around $10,500 per month.
- Treatment duration varies but often lasts 6–12 months depending on response.
Reimbursement and Market Factors
- Insurance coverage is largely available due to FDA approval.
- Out-of-pocket costs for patients vary based on insurance and assistance programs.
Price Trends and Projections
| Year |
Price Estimate (USD/month) |
Assumptions |
| 2023 |
$11,000 |
Stable pricing with current market strength |
| 2024 |
$10,800 |
Slight decrease anticipated due to biosimilar competition in RCC/HCC |
| 2025 |
$9,500 |
Impact of biosimilar approval, generics entering markets |
| 2026 |
$8,500 |
Further erosion, loss of exclusivity in some indications |
Note: Prices could decline further depending on biosimilar development, reimbursement policies, and market penetration.
Price Drivers and Risks
- Biosimilar Competition: Entry expected post-2024 could reduce prices by 30-50%.
- Patent Expiry: Patent expiration in 2029 limits exclusivity, increasing generic competition.
- Regulatory and Market Access: Changes in payer policies and healthcare regulations can influence net prices.
- Manufacturing Costs: R&D and manufacturing innovations could impact cost margins influencing pricing strategies.
Key Market and Price Outlook Summary
- The drug is positioned in a competitive segment with moderate market share.
- Pricing maintains a high premium, but the horizon shows gradual declines due to biosimilar growth.
- The next 2-3 years will define the impact of biosimilar entrance on unit prices.
- Long-term pricing stability depends on market exclusivity and innovation pace.
Key Takeaways
- NDC 13811-0717 (Lenvatinib) is a key player in multiple cancer indications with a projected price decline driven by biosimilar competition starting around 2024.
- Current monthly prices hover around $11,000, with slight decreases expected through 2025.
- Patent protection lasts until 2029, providing market exclusivity but constraining pricing flexibility.
- The global market share remains significant, but price erosion is imminent with biosimilar entry.
- Future pricing strategies should factor in regulatory changes, reimbursement policies, and biosimilar developments.
FAQs
Q1: When are biosimilars for Lenvatinib expected to enter the market?
A1: Biosimilar versions are likely to launch post-2024, contingent on regulatory approval and patent litigation outcomes.
Q2: What factors influence the drug’s price in the U.S.?
A2: Pricing is driven by market competition, reimbursement policies, manufacturer margins, and pharma negotiations.
Q3: How does patent expiry affect pricing strategies?
A3: Patent expiry enables biosimilar entry, prompting price reductions to maintain competitiveness.
Q4: What are comparable drugs in Lenvatinib’s indications?
A4: Sorafenib, Cabozantinib, and Pazopanib are primary competitors, with similar price frameworks and market shares.
Q5: How might future healthcare reforms impact the drug’s pricing?
A5: Reforms promoting biosimilar adoption and value-based pricing could accelerate price declines.
References
[1] American Cancer Society. (2021). Cancer facts & figures 2021.
[2] SEER Cancer Statistics Review, 2020. National Cancer Institute.
[3] EvaluatePharma. (2022). Oncology drug sales data.
[4] FDA. (2015). Lenvatinib approval documents.
[5] IMS Health. (2022). U.S. Prescription drug pricing analysis.
