Last updated: February 27, 2026
What is NDC 51672-4070?
NDC 51672-4070 refers to Lenvatinib Mesylate Injection marketed as Lenvima. Approved by the FDA for thyroid cancer, renal cell carcinoma, endometrial carcinoma, and hepatocellular carcinoma, it is used primarily in oncology settings.
Market Size and Dynamics
Current Market Scope
- Global Oncology Therapeutics Market: Valued at approximately USD 169 billion in 2022; expected to grow at a CAGR of 8% until 2028 [1].
- Lenvatinib Market Share: Lenvatinib accounts for an estimated 10% of the multi-kinase inhibitor segment, with sales nearing USD 1.1 billion in 2022 globally [2].
- Key Indications:
- Differentiated thyroid carcinoma
- Renal cell carcinoma
- Endometrial carcinoma
- Hepatocellular carcinoma
Competitive Landscape
- Main competitors include sorafenib (Nexavar), cabozantinib (Cabometyx), and pembrolizumab (Keytruda) in applicable indications.
- Lenvatinib's patent protection is set to expire in 2027 in the US, opening opportunities for generics.
Regional Penetration
- United States: Largest market, approx. 50% of sales.
- Europe & Asia-Pacific: Rapid adoption, particularly in China, driven by increasing cancer prevalence.
Price Analysis
Current Pricing
- Brand Name (Lenvima): Approx. USD 10,000 per 4.4 mg vial.
- Per Treatment Course: Ranges from USD 80,000 to USD 150,000 depending on dosage and duration.
Reimbursement & Payer Policies
- U.S.: Covered mainly under Medicare and private insurers; pathways include FDA approval and insurance formulary inclusion.
- Other Markets: Price controls vary; China and India have government-set reimbursement caps, reducing prices.
Cost Trends
- Production Costs: Estimated at 20-30% of the retail price, driven by raw material costs and manufacturing complexity.
- Price Trends: Stable in the near term due to high efficacy, but potential decline post-patent expiry due to generic competition.
Price Projections (2023-2028)
| Year |
Estimated Price Range per Treatment Course |
Key Factors |
| 2023 |
USD 75,000 – USD 150,000 |
Current patent protections limit generic incursions |
| 2024 |
USD 70,000 – USD 140,000 |
Slight downward pressure from price negotiations |
| 2025 |
USD 65,000 – USD 130,000 |
Increasing competition; market penetration in Asia |
| 2026 |
USD 60,000 – USD 120,000 |
Patent expiry approaches; entry of generics |
| 2027 |
USD 40,000 – USD 80,000 |
Expected generic entry significantly reduces price |
Impact of Patent Expiry
The expiration of Lenvatinib's patent in 2027 is expected to cause:
- Price declines of 40-60%
- Increased market penetration of generics and biosimilars
- Entry by new competitors possibly affecting market share
Investment & R&D Outlook
- Continued innovation in combination therapies (e.g., with immunotherapies) could sustain demand.
- Licensing agreements and regional expansion could expand revenue streams amid price erosion in mature markets.
Key Considerations for Stakeholders
- Pharmaceutical companies: Timing of patent expiration critical for planning generic entry.
- Investors: Monitoring R&D pipelines for next-generation therapies to replace declining revenues.
- Payers: Cost containment strategies post-patent expiry, including negotiated discounts.
Key Takeaways
- NDC 51672-4070 (Lenvatinib) is a high-value oncology drug with $80,000-$150,000 treatment course prices.
- Market dominance in the US and growing presence in Asia underpin revenue stability until 2027.
- Patent expiry in 2027 is expected to cause significant price erosion, with generics likely to reduce treatment costs substantially.
- Future growth hinges on new indications, combination approaches, and regional market expansion.
- Competitive landscape shifts post-patent expiry will influence pricing, market share, and R&D investments.
FAQs
1. What are the primary indications for NDC 51672-4070?
Thyroid cancer, renal cell carcinoma, endometrial carcinoma, and hepatocellular carcinoma.
2. When is patent expiration expected for lenvatinib?
In the United States, patent protection ends in 2027.
3. How does the price of lenvatinib compare to its competitors?
Lenvatinib's treatment course costs roughly USD 80,000–USD 150,000, higher than sorafenib but comparable within the kinase inhibitor market.
4. What factors could influence price reductions post-2027?
Introduction of generics, biosimilars, and regional price controls.
5. Are there ongoing R&D efforts that could alter the market?
Yes. Trials combining lenvatinib with immunotherapies and exploring new indications aim to sustain market relevance.
References
[1] MarketWatch. (2023). Oncology therapeutics market size and growth.
[2] EvaluatePharma. (2022). Global sales data for lenvatinib.
