Last updated: February 24, 2026
What is NDC 00781-6184?
NDC 00781-6184 is a specified drug product identified by the National Drug Code (NDC), used for pharmaceutical tracking and billing. This code corresponds to Lenvatinib mesylate (brand: Lenvima), a targeted cancer therapy used primarily for thyroid cancer, hepatocellular carcinoma, and other solid tumors.
Market Overview
Therapeutic Area and Indications
- Indications: Thyroid carcinoma, hepatocellular carcinoma, endometrial carcinoma, renal cell carcinoma.
- Mechanism: Tyrosine kinase inhibitor (TKI) targeting VEGFR, FGFR, PDGFR-alpha, RET, and Kit.
- Market Size (2022): Estimated global sales of Lenvatinib reached approximately $1.2 billion. U.S. sales accounted for roughly 45% of this figure, driven by increased adoption post-FDA approval (2021 for hepatocellular carcinoma).
Competitive Landscape
- Main competitors: Sorafenib (Nexavar), Pazopanib (Votrient), Cabozantinib (Cabometyx), and Regorafenib (Stivarga).
- Market share trends: Lenvatinib holds approximately 35-40% of the current TKI franchise for certain indications, with growth fueled by expanding label indications and ongoing clinical trials.
Distribution and Usage
- Patients: Estimated 7,000-8,500 patients in the U.S. for approved indications.
- Prescription patterns: Steady increase seen over the last three years, with a shift towards earlier use due to compelling efficacy data.
Pricing Analysis
Current Pricing
- Average Wholesale Price (AWP): Estimated at approximately $10,000 per month per patient, based on recent wholesale acquisition cost reports and pharmacy pricing data as of Q1 2023.
- Actual reimbursement rates: Typically 15-20% below AWP, with Medicare and private insurers paying between $8,000 and $8,500 per month per patient.
Cost Breakdown
- Per-unit cost: Lenvatinib is supplied in 4 mg and 10 mg capsules, with annual costs exceeding $100,000 per patient.
- Manufacturing cost: Estimated to be below $5,000 per patient per year, considering active pharmaceutical ingredient (API) costs, formulation, and packaging.
Price Drivers
- Patent exclusivity until at least 2030.
- Rare disease status in certain indications.
- Physician and payer acceptance influenced by clinical benefits and competition.
Price Projections (Next 5 Years)
| Year |
Estimated Wholesale Price (Monthly) |
Remarks |
| 2023 |
$10,000 |
Baseline, current market price |
| 2024 |
$9,800 |
Slight decrease expected due to payer negotiations |
| 2025 |
$9,600 |
Market saturation limits growth; efficiency improvements |
| 2026 |
$9,400 |
Potential generic entry delayed by patent protection |
| 2027 |
$9,200 |
Continued market stabilization |
Assumptions
- No significant patent challenges or generic entry before 2030.
- Moderate price erosion due to increased competition and biosimilar pathways.
- Inflation-adjusted growth in patient pool by 3-5% annually, driven by new indications and expanded clinical use.
Regulatory and Policy Impact
- Patent exclusivity: Extends to 2030, barring patent challenges.
- Pricing regulations: No immediate domino effect from policies like Medicare negotiations, but potential future pressure could lower reimbursement or influence wholesale prices.
- Biosimilar development: No biosimilars eligible, as Lenvatinib is a small molecule, not biologic, and patents for formulation and API protect market entry.
Key Market Opportunities and Risks
Opportunities
- Expansion into additional indications, such as prostate cancer or neuroendocrine tumors.
- Combination therapies that improve outcomes.
- Increased access through insurance coverage expansions.
Risks
- Competitive erosion from new therapies within TKIs or immunotherapeutics.
- Pricing pressure from payers due to cost-effectiveness debates.
- Patent challenges or regulatory delays affecting profitability.
Key Takeaways
- NDC 00781-6184 (Lenvatinib) operates within a a multi-billion dollar global cancer treatment market.
- Current pricing is around $10,000/month, with slight declines projected over the next five years.
- Patent protection extends until at least 2030, limiting generic competition and supporting relatively stable prices.
- Growth is driven by expanded indications and evolving combination regimens.
- Potential market disruptions include biosimilar competition and policy-driven price pressures.
FAQs
Q1: Will Lenvatinib’s price decrease significantly with patent expiration?
A: Likely, though patent protections extend until 2030, delaying generic entry and major price reductions.
Q2: How does Lenvatinib compare price-wise to similar therapies?
A: It is roughly on par with other TKIs, such as Sorafenib and Cabozantinib, which typically cost $9,000 to $11,000 per month.
Q3: Are new indications expected to impact revenue projections?
A: Yes, approval for additional cancers could increase patient volume and sales.
Q4: What factors could influence future pricing trends?
A: Regulatory changes, biosimilar developments, payer negotiations, and clinical trial outcomes.
Q5: How vulnerable is the market to biosimilar competition?
A: Limited, since Lenvatinib is a small molecule with patent protection, but competition from other TKIs remains significant.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2021). Lenvatinib (Lenvima) Approval and Indications.
[3] EvaluatePharma. (2023). Global Oncology Drug Market Analysis.
[4] CMS.gov. (2022). Reimbursement Policies for Cancer Therapies.
