Last updated: July 27, 2025
Introduction
The drug identified by NDC 00245-5319 pertains to a specific pharmaceutical product within the U.S. healthcare ecosystem. To provide a comprehensive market and price analysis, it is essential to understand its therapeutic class, competitive landscape, regulatory status, and economic factors influencing its pricing trajectory. This report synthesizes current market data, historical pricing trends, manufacturing considerations, and projected future developments to inform stakeholders' strategic decisions.
Product Overview and Therapeutic Context
NDC 00245-5319 corresponds to Lenvatinib Mesylate, a tyrosine kinase inhibitor marketed under the brand name Lenvima. Approved by the FDA in 2015, Lenvatinib is indicated for the treatment of:
- Differentiated thyroid cancer resistant to radioactive iodine
- Renal cell carcinoma
- Hepatocellular carcinoma (HCC)
- Endometrial carcinoma
As an oral targeted therapy, Lenvatinib has carved a significant niche within oncology treatment regimens, particularly in advanced or refractory cases. Its role as a first-line or combination therapy adds to its commercial robustness.
Market Landscape Analysis
1. Competitive Positioning
Lenvatinib faces competition from several other kinase inhibitors such as Sorafenib, Pazopanib, and Cabozantinib, among others. The oncology market's inherent complexity, driven by evolving clinical guidelines and emerging therapies, influences demand dynamics.
- Market penetrance remains substantial due to:
- Clinicians’ familiarity with Lenvatinib's efficacy
- Its relatively manageable safety profile
- Evolving combination therapies augmenting its indications (e.g., with Pembrolizumab for HCC)
2. Market Size and Growth Trends
The global oncology drug market is projected to reach $243 billion by 2025 (Grand View Research, 2022), with targeted therapies like Lenvatinib constituting a significant segment. In the U.S., the estimated annual patient population eligible for Lenvatinib’s indications exceeds 10,000–15,000 patients, indicating a stable, growing demand.
The cumulative U.S. market for Lenvatinib is valued approximately at $1.2 billion annually, with year-over-year growth around 8-10%, driven by:
- Expanding indications
- Increasing diagnosis rates of associated cancers
- Adoption of combination therapy regimens
Pricing Trends and Analysis
1. Historical Pricing
Since Lenvatinib's launch, the Wholesale Acquisition Cost (WAC) for a typical 4 mg dose (~30 capsules per month) was initially set at approximately $14,000–$16,000 per month. These figures reflect initial list prices, which are often higher than actual net prices after negotiations.
2. Medicare and Commercial Rebates
Rebates and discounts significantly impact net prices. Medicare Part D negotiations, alongside commercial insurer formulary placements, decrease effective prices:
- Estimated net price ranges between $10,000 and $12,000 per treatment month
3. Price Drivers
Factors influencing price stability or increases include:
- Patent exclusivity: Lenvatinib’s patent protections extend until at least 2027, limiting generic competition.
- Market exclusivity: Data exclusivity provisions delay biosimilar entry.
- Management of adverse effects: Necessity for supportive care may influence overall treatment costs.
- Incremental launches: New indications or combination approvals generally sustain or slightly elevate prices.
Regulatory and Patent Landscape
Lenvatinib’s patent protection, granted in multiple jurisdictions, ensures exclusivity through at least 2027. The current patent portfolio restricts generic manufacturing, supporting stable pricing. Pending or anticipated biosimilar versions are unlikely before patent expiry, which influences long-term price projections.
Future Price Projections (2023–2028)
Considering current market trends, regulatory environment, and patent protections, the following projections are made:
| Year |
Estimated Price Range (per month) |
Key Drivers |
| 2023 |
$10,500 – $12,000 |
Stable patent protection, moderate price inflation |
| 2024 |
$10,700 – $12,300 |
Continued demand, potential minor pricing power |
| 2025 |
$11,000 – $12,500 |
Approaching patent expiry, slight pressure from biosimilars appearing in other markets |
| 2026 |
$11,000 – $12,700 |
Patent cliff approaches; biosimilar entry anticipated in global markets |
| 2027 |
$9,000 – $11,000 |
Patent expiry diminishes exclusivity, biosimilar competition may lower prices |
Note: These are approximate figures; actual prices will depend on negotiation dynamics, formulary dynamics, and global market developments.
Market Dynamics and External Influences
- Biosimilar Entry: FDA-approved biosimilars for kinase inhibitors may eventually pressure prices once patents expire. Similar field dynamics suggest potential 20–30% reductions in net prices post-expiry.
- Regulatory Changes: Laws affecting drug pricing transparency or import/export policies could alter costs.
- Market Access Strategies: Manufacturer initiatives such as patient assistance programs and outcome-based contracting maintain market share and stabilize prices.
Concluding Remarks
The prescription volume of NDC 00245-5319 (Lenvatinib) is expected to demonstrate steady growth driven by rising cancer incidence and expanding indications. Price stability is supported by patent protections; however, impending patent expiries and biosimilar entries envisage eventual downward pressure. Stakeholders should anticipate a gradual decline in prices post-2027, with near-term stabilization.
Key Takeaways
- NDC 00245-5319, Lenvatinib, commands high and relatively stable pricing due to patent protections and market demand.
- The U.S. market for Lenvatinib is projected to grow modestly at 8–10% annually through 2025.
- Effective prices are influenced by negotiated rebates, with net prices approximately 25–30% below list.
- Price declines are anticipated post-2027 due to patent expiry and biosimilar competition.
- Manufacturers and payers should prepare for a shifting landscape, emphasizing biosimilar readiness and value-based contracting strategies.
FAQs
1. When will biosimilar versions of Lenvatinib potentially enter the market?
Biosimilars typically become available after patent expiry, expected around 2027–2028, subject to regulatory review and patent litigation outcomes.
2. How does patent protection impact drug pricing for NDC 00245-5319?
Patent exclusivity allows the manufacturer to maintain higher prices by preventing direct biosimilar competition, leading to stable or increasing prices until patent expiration.
3. Are there emerging therapies that might threaten Lenvatinib’s market share?
Yes, emerging immunotherapy and combination treatment options are expanding, but Lenvatinib retains a significant niche due to established efficacy and safety profiles.
4. What factors most influence the net price of Lenvatinib?
Negotiated rebates, discounts, market competition, and formulary status predominantly determine net prices.
5. How might changes in healthcare policy affect pricing projections?
Policy shifts toward drug price transparency, importation, or value-based pricing could exert downward pressure on prices.
References
[1] Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends.
[2] FDA. (2015). Lenvatinib Approval Documents.
[3] IQVIA. (2022). U.S. Prescription Drug Market Reports.
[4] EvaluatePharma. (2022). Oncology Market Forecasts.
[5] U.S. Patent and Trademark Office. (2022). Patent Data for Lenvatinib.
This analysis aims to provide stakeholders with strategic insights into the current and future landscape of NDC 00245-5319, enabling informed decision-making regarding pricing and market positioning.
