Last updated: February 19, 2026
What Is the Drug Product Corresponding to NDC 69543-0375?
NDC 69543-0375 is assigned to Lenvatinib mesylate in a 4 mg capsule, marketed as Lenvima. Approved by the FDA in 2015, Lenvatinib is a kinase inhibitor indicated for thyroid cancer, hepatocellular carcinoma, renal cell carcinoma, and other neoplasms.
Market Size and Key Players
Geographic Scope
The primary markets are the United States, European Union, Japan, and other developed nations.
Patient Demographics
Estimated U.S. patient population:
| Indication |
Estimated Patients |
Source |
| Thyroid Cancer (radioiodine-refractory) |
12,000 |
American Thyroid Association (2022) |
| Liver Hepatocellular Carcinoma |
40,000 |
American Cancer Society (2022) |
| Renal Cell Carcinoma |
73,750 |
National Cancer Institute (2022) |
Market Penetration
In 2022, Lenvima delivered approximately $750 million globally, with the U.S. accounting for nearly 60% of sales.
Competitive Landscape
Major competitors include:
- Sorafenib (Nexavar)
- Sunitinib (Sutent)
- Cabozantinib (Cabometyx)
- Regorafenib (Stivarga)
Lenvatinib maintains a significant share due to broad indications, despite competition.
Pricing Overview and Trends
U.S. Price Point
- List price per 4 mg capsule: approximately $11.00–$15.00.
- Estimated average wholesale price (AWP): $12.50 per capsule.
- Patient out-of-pocket costs vary based on insurance, typically ranging from $50–$200 per month after insurance subsidies.
Revenue Projection Assumptions
- Market Growth Rate: 5% CAGR from 2023-2028, driven by rising cancer incidences, expanding indications, and increased adoption.
- Price Trends: Slight increases of 1–2% annually, influenced by inflation, new formulations, and market dynamics.
- Market Share: Expected stabilization at roughly 20–25% of the oncology kinase inhibitor market.
5-Year Price Projection
| Year |
Estimated Wholesale Price per Capsule |
Projected Revenue |
Notes |
| 2023 |
$12.50 |
$750 million |
Baseline, 100% market share of current indications |
| 2024 |
$12.75 |
$787.5 million |
Slight price increase |
| 2025 |
$13.00 |
$826 million |
Market expansion continues |
| 2026 |
$13.25 |
$866 million |
Entry of biosimilars or generics (if applicable) |
| 2027 |
$13.50 |
$911 million |
Increased competition, price pressure |
Note: Exact projections depend on regulatory changes, patent status, and market dynamics.
Patent and Regulatory Status
- Patent protection: Patents protecting Lenvatinib expire in 2032 in the U.S.
- Next-generation formulations or biosimilars may enter the market post-2032, impacting pricing.
Policy and Market Dynamics Impacting Price
- Pricing regulations: U.S. policy debates could influence drug reimbursement and pricing.
- Healthcare reforms: Shifts toward value-based care may pressure pricing.
- Biosimilar entry: The introduction of biosimilars could lead to downward price adjustments.
Summary
Lenvatinib (NDC 69543-0375) is a key player in the oncology landscape with steady demand driven by multiple indications. Its current price point in the U.S. is approximately $12.50 per capsule, with moderate upward price pressures anticipated over the next five years. Market growth is supported by expanding indications and increasing global cancer rates. Competition chiefly from sorafenib, sunitinib, and other TKIs remains significant, but Lenvatinib maintains a substantial market share due to broad indications.
Key Takeaways
- The global Lenvatinib market was approximately $750 million in 2022.
- Average U.S. wholesale price: $12.50 per 4 mg capsule.
- Expected CAGR (2023–2028): 5%, with price increases of 1–2% annually.
- Patent protection extends to 2032, after which biosimilars may influence prices.
- Competitive landscape includes sorafenib and sunitinib.
FAQs
1. How does Lenvatinib compare with its competitors?
Lenvatinib offers broader indications than some competitors like Sorafenib but faces competition in specific indications like hepatocellular carcinoma.
2. What factors could lower Lenvatinib’s future prices?
Introduction of biosimilars, healthcare policy reforms, and increased market competition.
3. Is there potential for new indications to expand the market?
Yes. Trials are ongoing for additional cancers, which could increase demand.
4. How does insurance coverage influence consumer costs?
Insurance coverage reduces out-of-pocket costs, boosting adherence and sales volume.
5. What is the significance of patent expiration for pricing?
Patent expiry in 2032 could lead to biosimilar entry, increasing price competition and reducing costs.
References
[1] American Cancer Society. (2022). Cancer statistics.
[2] American Thyroid Association. (2022). Patient estimates.
[3] IQVIA. (2022). Market data for oncology drugs.
[4] U.S. Food and Drug Administration. (2015). Lenvatinib approval document.
