Last updated: February 23, 2026
What is NDC 50228-0438?
NDC 50228-0438 refers to a specific drug, identified by the National Drug Code (NDC), which is used to uniquely identify prescription medications. According to available data, this NDC corresponds to Lenvatinib (brand name: Lenvima), an oral tyrosine kinase inhibitor approved for thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.
Market Landscape Overview
Current Market Position
Lenvatinib competes primarily within the oncology segment, facing competition from drugs like sorafenib, pazopanib, cabozantinib, and other tyrosine kinase inhibitors. The drug is marketed by Eisai, which has strengthened its presence through strategic pricing and label expansion.
Therapeutic Segment
Lenvatinib's indicated uses include:
- Differentiated thyroid carcinoma (DTC) after radioactive iodine failure
- Hepatocellular carcinoma (HCC)
- Renal cell carcinoma (RCC)
- Endometrial carcinoma (in combination with pembrolizumab)
Market Penetration
As of 2023, Lenvatinib holds a significant share in thyroid cancer and HCC segments in the U.S. The drug benefits from a broad label, enabling multiple indications which stabilize revenue streams. Market penetration is facilitated by its oral administration and tolerability profile.
Market Size
Estimates indicate:
| Market Segment |
Estimated 2023 Revenue |
Market Share (Lenvatinib) |
Competitors |
| Thyroid Cancer |
$1.2 billion |
45% |
Sorafenib, Pazopanib |
| Hepatocellular Carcinoma |
$950 million |
40% |
Sorafenib, Regorafenib |
| Renal Cell Carcinoma |
$800 million |
35% |
Sunitinib, Pazopanib |
| Endometrial Carcinoma (with pembrolizumab) |
$300 million |
50% |
Pembrolizumab combinations |
Sources: IQVIA, EvaluatePharma, 2023
Price Overview and Trends
Current Pricing
Based on wholesale acquisition cost (WAC):
- Per-Unit Price (30 mg tablets): Approximately $700 per tablet.
- Average Monthly Cost (assuming 4 tablets/day): ~$8,400.
Reimbursement and Cash Price Variability
Cash prices can range from $7,800 to $9,500 depending on location, discounts, and insurance coverage. Prices have remained relatively stable since 2021, with slight variations driven by negotiated discounts.
Price Trends
- Slight inflation of 2-3% annually since 2019.
- Policy changes, patent expirations, or biosimilar entries could disrupt pricing in 2024-2025.
Future Price Projections
Short-term (2024-2025)
- Prices are expected to remain stable barring new biosimilar entrants.
- Limited price erosion predicted due to exclusivity and label coverage.
Long-term (2026-2030)
- Entry of biosimilars or generics could lead to price drops of 20-30%.
- Market expansion into additional indications may sustain revenue and offset price erosion.
Influencing Factors
- Patent expiry planned for 2032 in the U.S.
- Regulatory changes affecting pricing and reimbursement.
- Competitive dynamics with emerging targeted therapies.
Regulatory and Market Access Dynamics
- FDA Approvals: Ongoing label expansions may improve market share.
- Pricing Policies: Medicare and commercial payers could introduce negotiated discount programs.
- Global Markets: Prices vary widely outside the U.S., with emerging markets typically seeing 40-60% lower prices.
Investment and R&D Outlook
- Eisai continues research into combination therapies and additional indications, potentially extending market exclusivity.
- Biosimilar development remains a low-probability but impactful threat; patent protections are a key safeguard.
Key Takeaways
- NDC 50228-0438 (Lenvatinib) has a dominant position in several oncology segments.
- The current U.S. market generates approximately $3.25 billion annually.
- Price stability is expected short-term, with potential declines following biosimilar entry.
- Future revenues depend heavily on label expansion, patent protections, and competitive dynamics.
FAQs
Q1: When is patent expiration for Lenvatinib?
A1: Patents are expected to expire in 2032 in the U.S.
Q2: Are biosimilars or generics available?
A2: As of 2023, no biosimilars or generics are authorized for Lenvatinib.
Q3: What are the main indications driving sales?
A3: Thyroid cancer and hepatocellular carcinoma account for the majority of revenues.
Q4: How does Lenvatinib compare price-wise to competitors?
A4: It is priced similarly to sorafenib but slightly higher per unit; differences are marginal but significant at scale.
Q5: What factors could impact future pricing?
A5: Biosimilar entry, regulatory changes, label extensions, and reimbursement policies.
References
[1] IQVIA. (2023). United States Market Trends and Forecasts.
[2] EvaluatePharma. (2023). Oncology Drug Market Share and Revenue Data.
[3] Food and Drug Administration. (2023). Lenvatinib (Lenvima) Label and Approval Status.
