Last updated: February 15, 2026
What Is NDC 51991-0005?
NDC 51991-0005 is a drug identified by the National Drug Code (NDC). As of the latest data, it is labeled as Lenvatinib mesilate. Lenvatinib is an oral tyrosine kinase inhibitor used primarily for treating differentiated thyroid carcinoma, unresectable hepatocellular carcinoma, and certain types of kidney cancer. It was approved by the FDA in 2015.
Market Size and Demand Trends
Current Market Size
- The global oncology drugs market reached approximately $160 billion in 2022, with targeted therapies like Lenvatinib capturing a significant share.
- The U.S. market for Lenvatinib was estimated to generate approximately $2 billion annually in 2021-2022, according to IQVIA data.
- The drug is widely prescribed for thyroid, liver, and renal cancers, with a growing patient population driven by increased cancer diagnoses.
Key Market Drivers
- Rising incidence of thyroid, liver, and kidney cancers.
- Expanding approval indications for Lenvatinib.
- Increased adoption of oral targeted therapies over intravenous options.
- Aging population globally, contributing to higher cancer prevalence.
Competitive Landscape
- Direct competitors include Sorafenib, Pazopanib, Cabozantinib, and other tyrosine kinase inhibitors.
- Lenvatinib's brand name is Lenvima (by Eisai).
- Patents for Lenvatinib are set to expire or have expired in key markets by 2027, opening opportunities for generics.
Regulatory and Patent Status
- U.S. patent protections are expected to expire between 2025 and 2027.
- The manufacturer, Eisai, holds exclusivity agreements and orphan drug designations that extend commercial rights.
- Pending or granted biosimilar applications in the U.S. and EU could influence pricing and market share.
Pricing Trends and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $10,000 per month for a typical dose.
- Average retail price: Ranges from $9,500 to $11,000 per month.
- Commercial insurance reimbursements are slightly lower, often around $8,500 to $10,000 per month.
Price Trends
- Over the past five years, Lenvatinib prices have remained stable with minor fluctuations.
- Pricing pressure arises from impending patent expirations and competition from biosimilars.
- Manufacturers have employed rebates and patient assistance programs to maintain market share.
Projected Price Declines
| Year |
Estimated Average Monthly Price |
Comments |
| 2023 |
$10,000 |
Current pricing level |
| 2024 |
$9,800 |
Slight discount due to market dynamics |
| 2025 |
$9,200 |
Anticipated patent expiration and generic entry |
| 2026 |
$8,500 |
Increased competition, biosimilars entering market |
| 2027 |
$7,500 |
Widespread generic/biosimilar availability |
Assumptions
- Patent cliff timing aligns with regulatory filings.
- Biosimilar approvals and market entry occur according to regulatory schedules.
- Payor negotiations continue to exert pressure on drug prices.
Revenue and Market Share Outlook
- 2023-2024: Dominated by branded Lenvima, with a moderate decline expected.
- 2025-2027: Marked market share erosion as biosimilars and generics penetrate, reducing revenues for the originator.
- Post-2027: Prices could stabilize at lower levels, with generics capturing the majority of the market.
Key Factors Impacting Market and Price
- Regulatory approvals of biosimilars in major markets (U.S., EU, Japan).
- Patent litigation outcomes influencing exclusivity duration.
- Healthcare policies aimed at reducing drug costs.
- Advancements in competing therapies with superior efficacy or safety profiles.
- Generic manufacturing costs influencing break-even points for new entrants.
Key Takeaways
- Market size for NDC 51991-0005 (Lenvatinib) in oncology is approximately $2 billion in the U.S., with potentially higher global figures.
- Price stability has persisted in recent years but is expected to decline significantly due to patent expirations and biosimilar competition.
- Pricing projections suggest a 25-30% decrease within the next two years, reaching an average of $7,500 per month by 2027.
- Regulatory and patent landscapes will largely determine the timing and magnitude of price reductions.
- Market share will shift from branded to generic therapeutics post-patent expiry, affecting revenue streams and profitability.
FAQs
1. When is patent expiration for Lenvatinib in the U.S.?
Patent protections are expected to expire around 2025-2027, subject to legal challenges and extensions.
2. What are the key competitors to Lenvatinib?
Sorafenib, Pazopanib, Cabozantinib, and emerging biosimilars.
3. How will biosimilar entry affect prices?
Biosimilars typically reduce prices by 20-40%, increasing market competition and lowering overall drug expenditure.
4. What is the outlook for future indications of Lenvatinib?
Additional approvals, including for endometrial carcinoma and lung cancers, could expand demand.
5. How do reimbursement policies impact prices?
Reimbursement negotiations and payer formularies influence actual usable prices, often leading to discounts from list prices.
References
[1] IQVIA Institute for Human Data Science. "The Global Use of Medicine in 2022."
[2] FDA. "Lenvatinib (Lenvima) Approvals and Indications."
[3] MarketWatch. "Oncology Drugs Market Trends."
[4] EvaluatePharma. "2022 Data on Oncology Drug Pricing."
[5] Statista. "Main Competitors and Market Shares in Tyrosine Kinase Inhibitors."
