Last updated: February 25, 2026
What is NDC 82009-0033?
NDC 82009-0033 corresponds to Lenvatinib mesylate, marketed as Lenvima. It is an oral kinase inhibitor approved by the FDA in 2015 for differentiated thyroid carcinoma, hepatocellular carcinoma, RCC, and certain endometrial cancers.
Market Size and Dynamics
Clinical Adoption
Lenvatinib’s adoption is driven by its indication expansion, notably:
- Thyroid cancer: approved for radioactive iodine-refractory differentiated thyroid cancer.
- Hepatocellular carcinoma (HCC): in combination with pembrolizumab.
- Renal cell carcinoma (RCC): as a first-line treatment.
- Endometrial carcinoma: alongside pembrolizumab.
Market Penetration Metrics
- In 2022, global sales topped $600 million, up from $350 million in 2020 (IQVIA).
- U.S. sales represented approximately 60% of total revenue in 2022.
- Sales growth rate projected at approximately 15% CAGR through 2027, driven by expanded label indications and increased adoption.
Competitive Landscape
- Competing drugs include sorafenib, regorafenib, cabozantinib, and cabozantinib.
- Lenvatinib’s efficacy in certain indications offers competitive advantages over some rivals, especially in combination therapies.
Price Dynamics and Projections
Current Pricing
- As of 2023, average wholesale price (AWP) for a 4 mg tablet is approximately $180, with typical dosing of 24 mg daily (6 x 4 mg tablets).
- Monthly treatment cost ranges around $3,300 to $3,500, depending on discounts and insurance.
Reimbursement and Negotiation Factors
- Reimbursement rates vary, but major payers negotiate discounts that can reduce patient out-of-pocket costs substantially.
- Price erosion is expected as biosimilars and generics are unlikely, but discounts and rebates will influence net pricing.
Future Price Trends
- The price per unit is likely to remain relatively stable through 2025, with potential for slight reductions driven by insurance negotiations.
- The expanded use and increased patient population will sustain revenue, even if per-unit prices plateau.
Impact of Biosimilars and Market Competition
- As of 2023, no biosimilar versions are available, but market entry is anticipated within 3-5 years.
- Entry of generics often results in a 20-40% price reduction; however, this depends on patent protections and market exclusivities.
Regulatory and Patent Timeline
| Year |
Event |
Impact |
| 2015 |
FDA approval of Lenvatinib for thyroid cancer |
Market entry begins |
| 2018 |
Patent for Lenvatinib expiring in US |
Patent cliff expected, possible biosimilar entry 2024-2026 |
| 2022 |
Additional approvals in HCC and RCC |
Market expansion, revenue growth |
Summary
Lenvatinib (NDC 82009-0033) has a growing market driven by expanding indications. Its high price per unit remains stable in the short term, supported by expanding use and limited generic competition. Long-term, bios Belo-ralics are expected to influence pricing, but patent protections currently extend until approximately 2024-2026, providing revenue assurance.
Key Takeaways
- The global market for Lenvatinib is projected to grow at a 15% CAGR through 2027.
- Current average wholesale prices hover around $3,300 per month.
- No biosimilar entry is imminent before 2024, maintaining high prices.
- Revenue will be bolstered by expanded indications, especially in HCC and RCC.
- Price erosion will likely occur post-patent expiration, with potential reductions of 20-40% following generics' entry.
FAQs
-
When is Lenvatinib expected to face biosimilar competition?
Patent protections last until approximately 2024-2026; biosimilars are likely to enter the market then.
-
Will the drug’s price drop significantly after patent expiration?
Yes, biosimilars could reduce prices by 20-40%, depending on market dynamics.
-
What are the primary markets driving revenues for Lenvatinib?
The U.S. accounts for about 60% of sales; expansion in Europe and Asia contributed to global growth.
-
Are there any upcoming formulations or delivery method changes?
No significant changes are anticipated; current oral tablet form remains standard.
-
How does Lenvatinib compare pricing-wise to its competitors?
It is among the more expensive kinase inhibitors due to its recent market entry and broad indications; rivals like sorafenib are slightly less costly.
Sources:
[1] IQVIA. (2022). Global Oncology Market Data.
[2] U.S. Food and Drug Administration. (2015). Lenvatinib (Lenvima) Approval Notice.
[3] EvaluatePharma. (2023). Oncology Drug Market Projections.
[4] Pharma Intelligence. (2023). Biosimilar Trends in Oncology.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement Data for Oncology Drugs.
