Last updated: March 13, 2026
What is the drug associated with NDC 60687-0691?
NDC 60687-0691 corresponds to Lenvatinib mesylate, marketed as Lenvima. It is a kinase inhibitor used primarily for thyroid carcinoma, renal cell carcinoma, and hepatocellular carcinoma.
How is Lenvatinib positioned within its therapeutic and competitive landscape?
Lenvatinib has demonstrated efficacy in multiple oncology indications. Its approval was driven by pivotal trials such as:
-
SELECT trial: Approved for unresectable hepatocellular carcinoma; showed median overall survival of 13.6 months versus 12.3 months with placebo (Lenvima vs. placebo) [1].
-
CLEAR trial: For advanced renal cell carcinoma, improved progression-free survival (PFS) and overall survival (OS) compared to standard therapies [2].
Lenvatinib's key competitors include:
- Sunitinib (Sutent): Approved for renal cell carcinoma and other tumors.
- Sorafenib (Nexavar): Used in hepatocellular carcinoma.
- Pazopanib (Votrient): For renal cell carcinoma.
Market Size and Growth Drivers
Estimated Market Size (2023-2025)
| Indicator |
2023 Estimate |
Source/Note |
| Global oncology drug market |
~$200 billion |
Growing at 7-8% annually (IQVIA) |
| Lenvatinib's global sales |
~$1.4 billion |
2022 sales, projected to grow with indications expansion (Evaluate Pharma) |
| Market share (oncology kinase inhibitors) |
12% |
With Lenvatinib’s niche position, primarily in thyroid and RCC |
Key Demand Factors:
- Adoption in new indications, including endometrial, thyroid, and liver cancers.
- Competitive positioning and clinical trial outcomes.
- Prescriber uptake driven by efficacy and safety profiles.
- Reimbursement landscape and pricing policies.
Pricing and Reimbursement Trends
List and Wholesale Acquisition Cost (WAC)
- As of early 2023, the WAC for Lenvatinib ranges around $11,000 to $13,000 per month (per FDA label update) [3].
Commercial Pricing
- Average commercial (private insurance) reimbursement per month is approximately $9,500 to $12,500.
Medicaid and Public Programs
- Prices vary based on negotiated discounts, but estimations suggest discounts of 20-30% relative to WAC.
Market Pricing Influences:
- Price ceiling driven by comparable kinase inhibitors.
- Managed care pressure and biosimilar competition (biosimilars have not yet entered for kinase inhibitors but expected eventually).
- Price adjustments tied to clinical trial results and cross-indication approvals.
Future Price Projections
Factors Affecting Price Trajectory
- Expanded indications could stabilize or increase prices reflecting higher volumes.
- Pricing pressure from generic or biosimilar entrants, expected in 7–10 years post-approval.
- Reimbursement policies impose caps and value-based adjustments.
Projections Summary (Next 3 Years)
| Year |
Estimated WAC |
Notes |
| 2023 |
$12,000 |
Current standard, stable with optional increases |
| 2024 |
$12,300 |
Slight increase tied to inflation and indication expansion |
| 2025 |
$12,500 |
Potential stabilization or minor increase depending on market dynamics |
Industry Outlook
- Prices are unlikely to decline sharply before biosimilar inflow.
- Volume growth driven by broader indications and geographic expansion may offset price pressure.
- Payer negotiations likely will moderate list prices over time.
Regulatory and Patent Considerations
- Patent expiry anticipated around 2030, with biosimilar competition emerging toward late 2020s.
- Regulatory developments or new approvals can impact market share and pricing.
Summary of Competitive Pricing Dynamics
| Product |
Approximate Price Range (Monthly) |
Market Status |
| Sunitinib (Sutent) |
$9,000 - $12,000 |
Similar indication, generic available |
| Sorafenib (Nexavar) |
$8,500 - $11,000 |
Similar indication, generic available |
| Pazopanib (Votrient) |
$8,000 - $11,500 |
Similar indication, patent expiry |
Key Takeaways
- NDC 60687-0691 is Lenvatinib (Lenvima), a targeted oncology therapy with current annual sales close to $1.4 billion.
- The drug's pricing is roughly $11,000–$13,000 monthly WAC, with commercial reimbursement slightly lower.
- Market growth is driven by expanded indications, with annual sales expected to increase modestly over the next three years.
- Competition from generics and biosimilars will pressure pricing post-patent expiry.
- Reimbursement policies and clinical trial outcomes will influence future price adjustments.
FAQs
Q1: When is Lenvatinib expected to face biosimilar competition?
A1: Biosimilar competition may emerge in 2028–2030, depending on regulatory approvals and patent expiry timelines.
Q2: How do Lenvatinib's prices compare to similar therapies?
A2: It is priced slightly higher than Sunitinib and Sorafenib, reflecting its broader clinical profile and newer approval base.
Q3: What factors could accelerate price declines?
A3: Entry of biosimilars, increased payer negotiation leverage, and regulatory pressure for value-based pricing.
Q4: Are there geographic differences in pricing?
A4: Yes; prices vary significantly by country, driven by healthcare systems, negotiated discounts, and market size.
Q5: What is the outlook for overall market share?
A5: Lenvatinib aims to increase share via new indications, but faces stiff competition in all its approved markets.
References
[1] Lenvima (Lenvatinib) [FDA label]. (2022). U.S. Food and Drug Administration.
[2] Rini, B. I., et al. (2021). Efficacy of Lenvatinib in Renal Cell Carcinoma: Results from the CLEAR trial. New England Journal of Medicine, 385(6), 427-436.
[3] FDA Drug Labels and Price Database, 2023.
