Last updated: March 1, 2026
What is NDC 68682-0272?
The NDC 68682-0272 corresponds to Lenvatinib Mesilate (Lenvima), a prescription medication approved for the treatment of differentiated thyroid carcinoma, unresectable hepatocellular carcinoma, renal cell carcinoma, and other cancers in some formulations. It is marketed primarily by Eisai Inc.
Market Size and Demand Drivers
Market Scope
- Indications: Lenvatinib is primarily used in oncology for advanced thyroid cancer, hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC).
- Patient Population: US estimates indicate:
- Approximately 600,000 cases of differentiated thyroid cancer annually.
- Around 40,000 new cases of hepatocellular carcinoma per year.
- Roughly 76,000 cases of renal cell carcinoma.
- Market penetration varies by indication, with higher adoption in late-line therapies and in combination regimens.
Key Competitors
| Drug Name |
Indication |
Market Share (2022) |
Price Range (per unit) |
| Lenvatinib (Lenvima) |
Thyroid, HCC, RCC |
35% |
$10,000 - $13,000 |
| Sorafenib |
HCC, Renal cell carcinoma |
25% |
$9,500 - $12,000 |
| Cabozantinib |
RCC, thyroid cancer |
15% |
$11,000 - $14,000 |
| Other agents |
Various |
25% |
Varies |
Revenue Estimates
In 2022, US sales for Lenvatinib approximated $800 million, driven by increased adoption and combination therapy approvals. Peak sales could surpass $1.2 billion by 2027 if off-label use and expanded indications materialize.
Pricing Trends
- Lenvatinib prices have remained relatively stable since approval, with minor fluctuations based on formulary negotiations.
- For oncology drugs, list prices range from $10,000 to $13,000 per month.
Price Projections
Short-term (Next 1-2 Years)
- Prices are expected to stay flat or slightly decrease due to pressure from payers and increased biosimilar competition.
- Contractual discounts and rebates predominate, lowering effective prices by 10-20%.
Medium-term (3-5 Years)
- Introduction of biosimilars or generics could reduce prices by 30-50%.
- Expansion into combination regimens may influence price trajectories positively, with new formulations potentially commanding premium prices.
Factors Affecting Pricing
| Factor |
Impact |
| Biosimilar availability |
Downward pressure on list prices |
| Payer negotiations |
10-20% discounts on list prices |
| Expanded indications |
Opportunity for higher pricing, especially in combination therapies |
| Regulatory approvals |
Affect market penetration and pricing dynamics |
Regulatory and Policy Context
- The FDA approved Lenvatinib for multiple indications, including an orphan disease designation for some.
- CMS and private payers impose formulary restrictions and require prior authorization, influencing market access and price realizations.
Conclusion
The market for NDC 68682-0272 (Lenvatinib) remains sizable with steady revenue generation. Pricing is stabilizing but faces pressure from biosimilar entries and negotiations. Future volume increases are likely through expanded indications and combination therapies. Effective management of payer relationships and innovation in formulations will shape prices in the coming years.
Key Takeaways
- Current US market value approximates $800 million annually.
- Prices range from $10,000 to $13,000 per month; discounts lower effective prices.
- Biosimilars could reduce prices by up to 50% over the next 3-5 years.
- Market expansion depends on indication approvals and combination therapy adoption.
- Payer negotiations and regulatory decisions will significantly influence future pricing and access.
FAQs
1. What are the primary indications for NDC 68682-0272?
Lenvatinib treats differentiated thyroid carcinoma, unresectable hepatocellular carcinoma, and renal cell carcinoma.
2. How does biosimilar entry affect Lenvatinib’s price?
Biosimilars can lower prices by reducing list prices by up to half, depending on market competition and healthcare payer policies.
3. What is the typical monthly acquisition cost for Lenvatinib?
Between $10,000 and $13,000, with effective prices lowered by discounts and rebates.
4. Are there upcoming regulatory changes that could impact pricing?
Potential FDA approvals for additional indications or new formulations could influence market dynamics and prices.
5. How does payer negotiation impact Lenvatinib’s market access?
Rebates and formulary restrictions can lower the effective reimbursement, influencing net prices and sales volume.
References
- IQVIA. (2022). US Oncology Market Data.
- FDA. (2022). Lenvatinib (Lenvima) Approval History.
- Center for Medicare & Medicaid Services. (2022). Drug Reimbursements and Policies.
- EvaluatePharma. (2022). Oncology Drug Market Projections.
- Wolters Kluwer. (2022). Pharmaceutical Pricing and Reimbursement Trends.
[1] FDA. (2022). Lenvatinib (Lenvima) approval history. https://www.fda.gov/drugs/resources-information-approved-drugs/lenvatinib-lenvima
[2] IQVIA. (2022). US Oncology Market Data.
[3] EvaluatePharma. (2022). Oncology Drugs Market Projections.
[4] CMS.gov. (2022). Drug Reimbursements Policies.
[5] Wolters Kluwer. (2022). Pharmaceutical Price Trends.
