Last updated: March 15, 2026
What is the Drug Identified by NDC 51407-0461?
NDC 51407-0461 corresponds to Lenvatinib (marketed as Lenvima), a kinase inhibitor approved for the treatment of differentiated thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma. It is supplied by Eisai Inc. The drug inhibits multiple receptor tyrosine kinases, including VEGFR, FGFR, and PDGFR, which contribute to tumor angiogenesis.
Market Landscape
Market Size and Growing Segments
- The global oncology drug market exceeds $170 billion as of 2022.
- Lenvatinib's approved indications target niche oncology markets, with estimated sales of approximately $1.5 billion in 2022.
- The growing incidence of hepatocellular carcinoma and renal cell carcinoma fuels demand. The American Cancer Society reports about 54,000 new kidney cancers and 42,230 new liver cancers in the U.S. in 2023.
Competitive Positioning
- Lenvatinib faces competition from drugs like Sorafenib, Pazopanib, and Cabozantinib.
- It offers an oral administration route and a broader indication profile, which supports its market share.
- Key competitors' 2022 sales: Sorafenib (~$1.8B), Cabozantinib (~$850M), Pazopanib (~$600M).
Regulatory Status and Market Access
- Approved in multiple regions, including FDA (2015), EMA, and Japan.
- Reimbursement depends on regional health authorities; US Medicare and private insurers generally reimburse at favorable rates.
Current Pricing Dynamics
List and Net Prices
- The average wholesale price (AWP) for Lenvatinib is approximately $11,500 per 28-tablet pack.
- Average sales price (ASP) in the U.S. hovered around $10,800 per month in 2022.
- Price discounts for payers can reduce patient out-of-pocket costs to between $2,000 and $4,000 per month.
Price Trends
- No significant recent price increases; initial launch prices have stabilized.
- Price reductions projected in some markets due to increased generic competition expected after patent expirations around 2028.
Patent and Exclusivity Timeline
- Patents expire in 2028, with exclusivity extensions potentially granted based on additional indications or formulations.
- Patent protections prevent generic entry until expiration, supporting current pricing.
Price Projections (2023-2030)
| Year |
Estimated Price Range (per month) |
Key Assumptions |
| 2023 |
$9,500 – $11,000 |
No new competitors; stable demand |
| 2024 |
$9,300 – $11,000 |
Slight market share erosion for generics in advanced markets |
| 2025 |
$9,000 – $10,500 |
Entry of early generics in select regions |
| 2026 |
$8,500 – $10,000 |
Increased generic approvals, some price erosion |
| 2028 |
$7,000 – $9,500 |
Patent expiry; generic penetration begins |
| 2029 |
$6,500 – $9,000 |
Growing generic market share |
| 2030 |
$6,000 – $8,500 |
Market stabilizes with multiple generic options |
Key Influencing Factors
- Patent expiration and generic entry.
- Regional pricing and reimbursement policies.
- Disease prevalence and new indication approvals.
- Competition from emerging therapies, including immuno-oncology agents and combination regimes.
Opportunities & Risks
- Introducing new formulations or combination therapies could sustain pricing.
- Patent challenges or legal disputes might accelerate generic entry.
- Increasing biosimilar and generic competition may depress prices, especially after 2028.
- Market expansion into new indications could bolster revenue streams.
Summary
Lenvatinib (NDC 51407-0461) remains a high-value, branded oncology drug with stable pricing in its current indications. Anticipated patent expiration in 2028 indicates potential for significant price erosion, with generic entry projected to reduce average wholesale prices by approximately 20-30% within three years post-patent expiry. Market growth will depend on expanding indications, competitive dynamics, and regional reimbursement policies.
Key Takeaways
- The drug is a leading therapy for specific cancers, with 2022 sales around $1.5 billion.
- Current pricing remains stable but will face considerable pressure after 2028 due to patent expiry.
- Market expansion hinges on regulatory approvals for new indications and partnership strategies.
- Competition from generics could halve prices within 5 years post-patent.
- Price reductions and market share erosion are expected as biosimilars and generics increase.
FAQs
1. When is patent expiry for NDC 51407-0461?
Patent protections expire in 2028, allowing generic entrants thereafter.
2. How does competition affect the drug’s price in the coming years?
Price is expected to decline 20–30% within three years after patent expiry, driven by generic competition.
3. Are there any ongoing or upcoming regulatory changes impacting pricing?
No immediate regulatory changes; however, regional reimbursement policies and new indication approvals may influence market access.
4. Can combination therapies extend market exclusivity?
Potentially, if formulation patents are obtained or new indications are approved, delaying generic market entry.
5. What regional factors impact the drug’s pricing?
Reimbursement policies, healthcare infrastructure, and patent laws vary; US and European markets tend to sustain higher prices than emerging markets.
References
[1] American Cancer Society. (2023). Cancer Facts & Figures 2023.
[2] IQVIA. (2022). National Prescription Audit.
[3] U.S. Food and Drug Administration. (2015). Lenvatinib approval notice.
[4] Evaluate Pharma. (2022). Oncology market forecasts.
