Last updated: February 27, 2026
What is NDC 46122-0701?
NDC 46122-0701 is the National Drug Code identified for Lenvatinib Mesylate (Lenvima), used primarily to treat thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Current Market Landscape
Market Size and Usage
- Estimated US sales (2022): $700 million.
- Approved indications: Differentiated into thyroid, liver, and kidney cancers; expanding to other tumor types.
- Key competitors: Sorafenib, cabozantinib, nivolumab.
- Patient population: Approximately 20,000 to 25,000 patients in the US receive Lenvatinib therapy annually.
- Pricing context: Historically, launch price of Lenvatinib varied between $11,000 and $13,000 per month.
Pricing Trends
| Year |
Monthly Price |
Notes |
| 2018 |
$12,500 |
Launch year; initial pricing |
| 2019 |
$12,200 |
Slight reduction after initial uptake |
| 2020 |
$11,900 |
Price stabilization |
| 2021 |
$11,500 |
Slight downward trend |
| 2022 |
$11,300 |
Price continues decline; competition increases |
Market Dynamics
- Reimbursement landscape: Managed care favors negotiated discounts.
- Market penetration: Growing, but constrained by competition and dosing limits.
- Patent and exclusivity: Patent protections extend into 2027 with pending formulations and indications.
Price Projections (2023-2027)
Assumptions
- Routine annual price reductions of 1-2% driven by competition and biosimilar entries.
- Introduction of biosimilars or generic versions expected around 2026.
- Increased competition from other kinase inhibitors and immunotherapies.
Projected Price Trajectory
| Year |
Estimated Monthly Price |
Description |
| 2023 |
$11,000 |
Slight dip due to competitive pressures |
| 2024 |
$10,700 |
Increasing biosimilar presence |
| 2025 |
$10,400 |
Approaching generic market entry |
| 2026 |
$8,000–$9,000 |
Biosimilars/generics intro; potential pricing discounts |
| 2027 |
$8,000–$9,000 |
Stabilization of biosimilar prices |
Market Share Impact on Price
- Brand dominance: Initially retains 70-80% market share before biosimilar entry.
- Post-biosimilar: Brand share declines to 30-50%, pressure on pricing.
Investment and R&D Considerations
- Lenvatinib remains a substantial revenue generator until biosimilar competition expands.
- Value of pipeline candidates: New formulations and combination therapies could sustain pricing.
- Pricing strategies: Price erosion risks prompt payers to favor lower-cost alternatives over the forecast period.
Key Takeaways
- NDC 46122-0701, Lenvatinib, maintains high prices with gradual declines.
- Market size in the US stands near $700 million annually, with growth limited by competition.
- Biosimilar entry around 2026 will catalyze significant price erosion.
- Upward pricing flexibility is constrained by increased regulatory and payer pressure.
- R&D efforts focused on combination therapies could offset pricing pressures.
FAQs
Q1. What factors influence the future price of NDC 46122-0701?
Price is driven by competition from biosimilars, generic entries, and payer negotiations.
Q2. When are biosimilars expected to enter the market?
Biosimilar versions could launch as early as 2026, depending on regulatory approval timelines.
Q3. How does the market size affect pricing?
A larger patient population sustains higher prices, but growth is limited by clinical uptake and competitor drugs.
Q4. What are the main therapeutic competitors?
Sorafenib, cabozantinib, nivolumab, and emerging immunotherapies.
Q5. How might new indications impact pricing?
New approved indications can extend exclusivity and sustain higher prices temporarily but may also dilute market share.
Sources:
- IQVIA. (2022). U.S. Prescription Drug Market Data.
- SSR Health. (2022). Prescription Price Trends.
- FDA. (2022). Approved indications for Lenvatinib.
- Evaluate Pharma. (2022). Oncology drug forecast.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies.
