Last updated: March 13, 2026
What Is NDC 46122-0244?
NDC 46122-0244 refers to a specific medication listed in the National Drug Code (NDC) directory. This code corresponds to a branded or generic pharmaceutical product. Based on available data, this NDC is identified as Lenvatinib mesylate, marketed under the brand Lenvima.
Market Overview
Indications and Usage
Lenvatinib is an oral multikinase inhibitor approved for advanced or metastatic thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma in adult patients. Its primary therapeutic markets include oncology segments focused on targeted cancer therapy.
Market Size
The global market for kinase inhibitors like Lenvatinib has experienced consistent growth. As of 2022, the global oncology drug market was valued at approximately USD 165 billion and projected to grow at a CAGR of 8.5% through 2030 [1].
Lenvima-specific sales in 2022 were estimated at approximately USD 850 million in the United States, reflecting increased adoption in multiple indications and expanded label approvals [2].
Market Dynamics
- Growing cancer incidence: An aging population and increased screening lead to higher diagnosis rates.
- Emerging indications: Additional approvals, including for hepatocellular carcinoma (HCC) and endometrial carcinoma, expand market share.
- Competitive landscape: Key competitors include sorafenib (Nexavar), pazopanib (Votrient), and newer agents like cabozantinib (Cabometyx).
Regulatory and Reimbursement Environment
Reimbursement policies vary by region, impacting market penetration. In the U.S., coverage is reinforced by Medicare and private insurers. Price negotiations and formulary placements influence access.
Pricing Trends and Projections
Current Pricing
| Region |
Average Wholesale Price (AWP) per 30-day supply |
Notes |
| United States |
USD 13,500–14,500 |
List prices; actual patient prices vary. |
| Europe |
EUR 11,000–EUR 13,000 |
Subject to national pricing policies. |
| Canada |
CAD 17,500–CAD 19,000 |
Reflects exchange rate and regional policies. |
Price Components
- Wholesale acquisition cost (WAC): Reflects manufacturer’s list price before discounts.
- Net price: Actual paid amount after rebates, discounts, and negotiations.
- Patient out-of-pocket: Varies based on insurance coverage and assistance programs.
Key Price Drivers
- Generic Entry: Expected within 5-7 years post patent expiry, placing downward pressure on prices.
- Market Access: Payer negotiations and formulary placements can lead to significant discounts.
- Supply chain factors: Manufacturing costs and supply stability influence pricing.
Price Projections (Next 5 Years)
| Year |
Estimated Average Price per 30-day Supply |
Basis for Projection |
| 2023 |
USD 13,500–14,500 |
Current list prices. |
| 2024 |
USD 12,500–13,500 |
Anticipated negotiations and emerging competition. |
| 2025 |
USD 11,500–12,500 |
Increased market penetration and early biosimilar developments. |
| 2026 |
USD 10,500–11,500 |
Potential generic availability; discounts rise. |
| 2027 |
USD 9,500–10,500 |
Biosimilar market entry reduces prices further. |
Competitive and Patent Landscape
- Patent protections: Filed patents extend until 2027–2029, depending on the jurisdiction.
- Biosimilars: European markets have seen biosimilar development; U.S. biosimilar approval is pending.
Investment and R&D Considerations
- Continued clinical trials may expand indications, supporting long-term revenue.
- Patent expiry timelines are crucial for strategic planning.
- Price sensitivity and payer policies will influence revenue streams.
Key Takeaways
- NDC 46122-0244 (Lenvatinib) has established a substantial market share within oncology.
- The global oncology market is expected to grow at a CAGR of approximately 8.5% through 2030.
- Current list prices range between USD 13,500 and USD 14,500 per month; prices are expected to decline gradually due to generic competition.
- Price projections indicate reductions to USD 9,500–10,500 by 2027, contingent on biosimilar market developments.
- Patent expirations in the late 2020s will likely accelerate price erosion, emphasizing the importance of pipeline development and market expansion.
FAQs
Q1: When is patent protection for NDC 46122-0244 expected to expire?
Patent protection extends until approximately 2027-2029, varying by jurisdiction.
Q2: What indications drive the current demand for Lenvatinib?
Demand is driven by approvals for thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Q3: How do biosimilars impact future pricing?
Biosimilar entry is expected to lower prices, especially post-patent expiry, with reductions potentially exceeding 30%.
Q4: What are the main competitors to Lenvatinib?
Sorafenib (Nexavar), pazopanib (Votrient), and cabozantinib (Cabometyx) are primary competitors.
Q5: How do regional pricing policies influence market values?
Pricing negotiations, reimbursement policies, and regulatory environments significantly affect drug prices and market access.
References
[1] Grand View Research. (2022). Oncology Drug Market Size, Share & Trends.
[2] EvaluatePharma. (2022). Oncology Market Data and Sales Reports.
