Last updated: March 19, 2026
What is NDC 60846-0801?
NDC 60846-0801 refers to a specific pharmaceutical product listed in the U.S. National Drug Code system. Based on available public resources, it corresponds to Lenvatinib mesylate (Lenvima), used primarily for the treatment of thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Market Size and Demand Drivers
1. Therapeutic Area and Oncology Niche
Lenvatinib is a multi-kinase inhibitor impacting tumor angiogenesis and proliferation. Since its FDA approval in 2015, sales volume has increased due to expanding indications.
2. Key Indications and Approvals
| Indication |
FDA Approval Year |
Market Impact |
| Differentiated thyroid carcinoma |
2015 |
First approval; high unmet need |
| Hepatocellular carcinoma |
2018 |
Boosted sales; expanding use |
| Renal cell carcinoma |
2019 |
Increased adoption |
3. Market Size and Revenue
The global oncology drug market reached $153 billion in 2022. Lenvatinib’s specific sales are estimated at approximately $1.2 billion in 2022, mainly in the U.S. and Europe.
4. Competitive Landscape
Lenvatinib competes with drugs such as Sorafenib, Everolimus, Cabozantinib, and newer agents in combination regimens. Patent exclusivity extends until 2027, after which biosimilar or generic versions could enter.
Current Pricing and Cost Structure
1. Average Wholesale Price (AWP)
| Formulation |
Typical Weekly Cost |
Notes |
| 4 mg capsules |
~$4,900 |
Depending on dosage schedule |
| 10 mg capsules |
~$9,300 |
Higher strength, similar per-unit cost |
2. Reimbursement and Payer Trends
Commercial plans and Medicare Part D cover Lenvatinib with prior authorization. The average patient out-of-pocket is approximately $300-$800/month. Insurance coverage, copay assistance programs, and negotiation terms influence the net price manufacturers realize.
3. Cost Factors for Manufacturers
Raw material costs, manufacturing complexity, quality controls, and regulatory compliance dominate cost structures. The active pharmaceutical ingredient (API) cost, estimated at 20% of the final price, varies by supplier and scale.
Price Projections and Market Trends
1. Short-term (2023-2025)
Price levels are expected to remain stable due to patent exclusivity and limited biosimilar competition. Retail prices could see slight increases (2-3%) driven by inflation and supply chain costs.
2. Mid-term (2026-2030)
Patent expiry in 2027 opens market to biosimilars or generics, likely reducing prices by 30-50%. Entry of biosimilars will lead to competition-based price erosion.
3. Long-term (2030 and beyond)
Post-patent, wholesale prices may stabilize at 50-70% lower than current levels, assuming biosimilars dominate the market and payers negotiate aggressively.
4. Potential Price-Influencing Factors
- Regulatory changes: Accelerated approvals and biosimilar pathways could influence pricing.
- Market competition: New combination therapies may shift market share.
- Therapeutic advances: Improvement in patient outcomes or new indications can impact demand and pricing.
Regulatory and Policy Impact
The baseline for price progression assumes no major shifts in U.S. policy or healthcare reimbursement frameworks. Price controls or value-based pricing models could either moderate or accelerate decline post-patent.
Summary of Key Data
| Metric |
Value |
| 2022 global sales |
~$1.2 billion |
| Current wholesale price per capsule |
~$4,900 (4 mg), ~$9,300 (10 mg) |
| Patent expiry |
2027 |
| Estimated biosimilar entry price reduction |
30-50% below current prices |
| Expected price decline post-2027 |
50-70% |
Key Takeaways
- NDC 60846-0801 (Lenvatinib) has shown growing sales driven by expanded indications.
- Price stability is expected until patent expiry in 2027.
- After patent expiry, biosimilar entry could reduce wholesale prices significantly.
- Market share will depend on the pace of biosimilar approval and utilization trends.
- Cost pressures and regulatory policy changes will influence future pricing.
FAQs
Q1: When will biosimilars for lenvatinib likely enter the market?
A1: Biosimilar development is ongoing; approval expected post-2027 when patent protection expires.
Q2: How might changes in healthcare policies impact the drug's price?
A2: Price caps, value-based pricing, or increased biosimilar use could both lower costs and influence market dynamics.
Q3: What are the main competitive advantages of lenvatinib?
A3: Multiple approved indications, once-daily dosing, and demonstrated efficacy in various cancers.
Q4: How does the current patent landscape influence pricing?
A4: Patent protection until 2027 supports premium pricing; expiry triggers price reductions.
Q5: What are the key risks to market share for lenvatinib?
A5: Late market entry of biosimilars, new combination therapies, or safety concerns.
Sources:
[1] IQVIA. (2022). Global Oncology Market Overview.
[2] U.S. Food and Drug Administration. (2015). Lenvatinib NDA approval documents.
[3] FDA. (2018). Hepatocellular carcinoma indication expansion.
[4] EvaluatePharma. (2022). Drug sales and patent expiry projections.
[5] Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for oncology drugs.
