Last updated: February 20, 2026
What is NDC 68180-0947?
NDC 68180-0947 corresponds to Lenvatinib Mesylate capsules, marketed under the brand Lenvima. Approved by the FDA for specific cancer treatments, including differentiated thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Market Overview
Therapeutic Area and Market Dynamics
Lenvatinib competes within the targeted cancer therapy segment, characterized by high adoption for intractable cancers. The global oncology drug market reached approximately $175 billion in 2022, with targeted therapies comprising roughly 28% of sales.
Lenvatinib's markets include the US, Europe, and select Asian countries, emphasizing patients with advanced or metastatic disease. Growth is driven by expanding indications, combination therapies, and ongoing clinical trials.
Key Competitors
| Drug Name |
Indications |
Annual Global Sales (2022) |
Comments |
| Sorafenib |
Renal cell, hepatocellular carcinoma |
~$800 million |
First-mover in similar indications |
| Cabozantinib |
Thyroid, renal, hepatocellular |
~$1.2 billion |
Competitor with broader indications |
| Regorafenib |
Colorectal, gastrointestinal stromal tumors |
~$600 million |
Similar targeted kinase inhibitor |
Market Drivers and Barriers
Drivers:
- Expanding approved indications
- Increasing prevalence of target cancers
- Preference for oral therapies over infusion-based treatments
- Positive clinical trial outcomes supporting combination regimens
Barriers:
- Patent expirations for older TKIs
- High development costs
- Competitive landscape with multiple options
- Reimbursement challenges in some regions
Price Analysis
Current Pricing
Analysis of retail and wholesale acquisition costs (WAC):
| Region |
Average Wholesale Price per 30-capsule bottle |
Notes |
| United States |
~$12,000 |
Approximate WAC for 4 mg capsules (~240 mg total) |
| Europe |
€8,500 |
Similar dosing but lower price points |
| Canada |
CAD 15,200 |
Slightly higher than US prices |
Note: Actual patient-paid prices vary due to insurance, discounts, and rebates.
Pricing Trends
- The initial US WAC for Lenvima was set around $12,000 in 2020.
- Price adjustments have been minimal, around 2-3% annually, reflecting limited generic competition due to patent protections.
- In markets like Europe, prices are often negotiated with health authorities, leading to lower nominal prices.
Patent and Exclusivity Status
Patent expiry scheduled for 2030, with potential for data exclusivity until 2035. This limits generic entry during the forecast period but allows for biosimilar competition later.
Price Projections (2023–2028)
| Year |
Estimated WAC for 30-capsule bottle |
Factors Influencing Price |
| 2023 |
$12,000 |
No significant change; price plateau |
| 2024 |
$12,300 |
Slight inflation adjustment |
| 2025 |
$12,600 |
Continued inflation; potential demand-driven price adjustments |
| 2026 |
$12,900 |
Patent protections prevent generics; steady pricing |
| 2027 |
$13,200 |
Market stabilization; generic competition unlikely before 2030 |
| 2028 |
$13,600 |
Price increases align with inflation |
Notes: Prices assume no major changes in regulation, patent status, or clinical policies.
Commercial Outlook
- The lack of generic competition keeps prices stable.
- Expansion of indications and combination therapies could increase demand and justify modest price increases.
- Payers may push for discounting or value-based agreements, affecting net pricing.
- Post-2030, biosimilar or generic entries could significantly reduce prices, potentially by 50% or more.
Key Takeaways
- NDC 68180-0947 (Lenvatinib) currently maintains a stable retail price around $12,000 per bottle.
- Market growth is driven by expanding indications and preference for oral targeted therapies.
- Competition from similar TKIs is significant, but patent protections keep prices high until at least 2030.
- Price projections suggest modest annual increases aligned with inflation, with potential for decreases post-patent expiration.
FAQs
Q1: When does patent exclusivity for Lenvatinib expire?
A1: Expected in 2030, potentially extending to 2035 with data exclusivity.
Q2: Are biosimilars or generics available for Lenvatinib?
A2: Not currently; patent protections prevent generic entry until 2030.
Q3: How do prices in the US compare to Europe?
A3: US prices (~$12,000) are higher than negotiated European prices (~€8,500), owing to different pricing and reimbursement systems.
Q4: What factors could influence future price reductions?
A4: Entry of biosimilars post-2030, regulatory changes, or reimbursement negotiations.
Q5: How does the clinical pipeline impact the market?
A5: Positive trial results and expanded approvals could increase demand, potentially stabilizing or raising prices temporarily.
References
[1] Evaluate Pharma. (2022). Global Oncology Market Forecast.
[2] IQVIA. (2022). Worldwide Oncology Market Data.
[3] FDA. (2018). Lenvatinib [Lenvima] Approval Summary.
[4] ASCO. (2022). Targeted Therapy Market Trends.
