Last updated: February 22, 2026
What is the drug associated with NDC 10147-0571?
NDC 10147-0571 corresponds to Lenvatinib mesylate (Lenvima), an oral kinase inhibitor approved for multiple cancer indications. It is primarily indicated for thyroid cancer, hepatocellular carcinoma, renal cell carcinoma, and endometrial carcinoma.
How large is the current market for Lenvatinib?
The global oncology drug market exceeds $150 billion annually. Lenvatinib's contribution centers on its niche in targeted therapies. In 2022, the drug generated approximately $1.2 billion in U.S. sales, with global revenue estimated around $1.8 billion. Sales growth has averaged 20% annually since 2020, driven by expanding indications and increased adoption.
Key market segments:
- Thyroid cancer: The original approved indication.
- Hepatocellular carcinoma (HCC): Approved in 2018; driven by rising HCC incidence.
- Renal cell carcinoma (RCC): Approved in 2019; growing use in advanced RCC.
- Endometrial carcinoma: Approved in combination with pembrolizumab in 2021.
What are the competitive dynamics?
Lenvatinib faces competition from other tyrosine kinase inhibitors (TKIs).
| Drug |
Indications |
2022 Global Sales |
Market Share (%) |
| Lenvatinib |
Thyroid, HCC, RCC, Endometrial |
$1.8B |
25% |
| Sorafenib |
HCC, RCC |
$1.4B |
20% |
| Lenvatinib + Pembrolizumab |
Endometrial cancer |
N/A |
8% (combined) |
| Other TKIs (e.g., Axitinib, Pazopanib) |
Various |
$4.0B total |
47% (combined) |
The drug's position benefits from multiple approvals but faces competition from newer agents with similar or broader activity.
What are the key factors influencing price projections?
1. Current Pricing
- Wholesale Acquisition Cost (WAC): Approx. $12,000 per 28-day supply.
- Post-rebate/net prices likely 20-30% lower.
- Average patient annual cost: ~$45,000.
2. Market Penetration Trends
- In the U.S., payer coverage is robust with median patient access expanding.
- The number of treated eligible patients in the U.S. was approximately 15,000 in 2022, projected to grow 10% annually over the next five years due to expanded indications.
3. Regulatory and Patent Landscape
- Patent protections extend through 2027 in the U.S.
- Biosimilar or generic entrants are not applicable; prices unlikely to significantly fall before patent expiry.
4. Pricing Policies and Insurance Coverage
- Payer negotiations and specialty drug management influence net prices.
- Introduction of value-based arrangements may cap expenditures.
5. Market Dynamics
- Emerging combination therapies (e.g., with pembrolizumab) may influence monotherapy sales.
- Pricing adjustments often follow competition and reimbursement policies.
What are the projections for future prices?
| Year |
Estimated WAC per 28-day supply |
Expected Sale Price (after discounts) |
Comments |
| 2023 |
$12,000 |
~$8,400 |
Stable pricing; growing volume |
| 2025 |
$12,500 |
~$8,750 |
Slight increase, inflation adjustment |
| 2030 |
$13,000 |
~$9,100 |
Marginal increase; patent exclusivity remains |
Prices are expected to remain relatively stable until patent expiration in 2027, barring regulatory changes. Cost containment efforts, such as biosimilar development, could pressure prices post-patent.
How will the market evolve?
The expansion of indications and adoption rates should support revenue growth. However, competitive pressures from other TKIs and combination regimens, along with evolving reimbursement landscapes, may influence future pricing strategies.
Summary of risks and opportunities:
- Risks: Patent expiry leading to biosimilar entry; competitive drug innovations; payer pushback on high prices.
- Opportunities: Expansion into new indications; combination therapies confirming efficacy; negotiated value-based pricing models.
Key Takeaways
- The NDC 10147-0571 corresponds to Lenvatinib (Lenvima), with a current global revenue of approximately $1.8 billion.
- Current wholesale prices are around $12,000 per 28-day supply, with net prices likely 20-30% lower.
- The market is expanding due to additional approved indications and increased patient access, with annual sales growth of 10-20%.
- Prices are projected to remain stable through 2025, with slight increases aligned with inflation and market dynamics.
- The impending patent expiry in 2027 presents risks of competitor entry and price erosion.
Frequently Asked Questions
1. What are the primary indications for Lenvatinib?
Thyroid cancer, hepatocellular carcinoma, renal cell carcinoma, and endometrial carcinoma.
2. When are biosimilars or generics expected for Lenvatinib?
Patent protections expire in 2027 in the U.S., opening potential for biosimilar development.
3. How does Lenvatinib compare price-wise to its competitors?
It is broadly comparable, with annual treatment costs around $45,000. Competitors like sorafenib and axitinib have similar price ranges.
4. What factors influence future price trends?
Patent status, market expansion, competition, and reimbursement policies.
5. How might combination therapies impact the market?
They can increase overall sales but may pressure monotherapy prices and shift market dynamics towards broader regimens.
References
[1] IQVIA. (2022). Oncology Market Data.
[2] FDA. (2018). Lenvatinib Approval for HCC.
[3] EvaluatePharma. (2022). Oncology Drug Market Trends.
