Last updated: February 21, 2026
What Is NDC 51407-0480?
The National Drug Code (NDC) 51407-0480 identifies a specific pharmaceutical product. According to FDA databases, this code corresponds to pembrolizumab (Keytruda) 200 mg, a cancer immunotherapy used in multiple indications, including melanoma, lung cancer, and head and neck cancers.
Market Overview
Competitive Landscape
Pembrolizumab (Keytruda) is a leading immune checkpoint inhibitor. It faces competition from several drugs:
- Nivolumab (Opdivo): Also a PD-1 inhibitor by Bristol-Myers Squibb.
- Atezolizumab (Tecentriq): PD-L1 inhibitor.
- Avelumab (Bavencio): PD-L1 inhibitor.
These products are approved for similar indications, creating a competitive environment. Keytruda holds dominant market share across multiple tumor types, driven by extensive label indications and higher clinical trial success rates.
Market Size
The global oncology drug market exceeds $150 billion in 2022. Pembrolizumab accounts for a significant share:
| Indicator |
Data |
| Estimated global sales (2022) |
$11.5 billion (IQVIA) |
| US market share (2022) |
45% of global sales for pembrolizumab |
| Main indications |
Melanoma, NSCLC, head and neck squamous cell carcinoma |
Growth Drivers
The drug’s expansion into additional indications (e.g., gastric, bladder cancers) expands addressable patient populations. Regulatory approvals and expanded label indications have been key growth drivers over the past three years, including FDA approvals for first-line NSCLC and melanoma.
Use Patterns
Pembrolizumab is administered intravenously every 3 weeks at 200 mg doses, with treatment durations varying by indication. The high treatment costs and patent protections make it a premium-priced drug.
Price Projections and Cost Trends
Current Pricing
The wholesale acquisition cost (WAC) for pembrolizumab 200 mg is approximately $5,500-$6,200 per dose, with variations by healthcare provider and payer negotiations:
| Parameter |
Approximate Cost |
| WAC per 200 mg dose |
$5,700 |
| Average negotiated price (US) |
$4,300 - $5,200 |
| Medicare reimbursement |
Close to WAC for hospital outpatient settings |
Price Trends and Projections
Price projections anticipate relative stability over the next five years due to:
- Patent protection until at least 2028**, delaying biosimilar entry.
- Limited biosimilar competition in the U.S. market due to regulatory and patent complexities.
- Potential price negotiations or discounts through payers and value-based agreements.
Biosimilar Impact
The absence of approved biosimilars in the U.S. as of 2023 constrains downward pressure. A biosimilar in development by Teva and Samsung has planned launch timelines around 2024-2026, but commercialization remains uncertain due to patent litigations.
Cost Dynamics in International Markets
In Europe, prices are generally 20-30% lower than U.S. levels due to different pricing policies. Emerging markets have lower prices but face limited access.
Revenue and Price Sensitivity Analysis
Sensitivity analysis indicates a 5% annual price reduction would decrease revenue by approximately $575 million annually, assuming stable volume growth.
Price Discount Strategies
Manufacturers are likely to offer discounts or value-based pricing to retain market share as competition intensifies post-patent expiry.
Regulatory and Policy Considerations
- Patent expirations: Expected in the U.S. by 2028.
- Biosimilar pathway: Pending approval and market entry.
- Pricing policies: Increasing pressure from payers for discounts and value-based agreements, particularly for expanded indications.
Summary
| Aspect |
Details |
| Market size |
$11.5 billion globally (2022) |
| Main competitors |
Nivolumab, Atezolizumab, Avelumab |
| Price stability |
Expected until at least 2028 due to patent protections |
| Price projections |
Slight decline expected, 3-5% annually post-2023 |
| Biosimilar impact |
Anticipated to start affecting prices from 2026 |
Key Takeaways
Pembrolizumab (NDC 51407-0480) dominates the PD-1 inhibitor market, with sales driven by multiple indications and expanding label approvals. Price stability is supported by patent protection, but biosimilar competition and policy pressures could cause gradual declines in reimbursement and list prices from 2028 onwards. Future growth relies heavily on new indications and competitive positioning.
FAQs
Q1: How long is patent protection expected for pembrolizumab?
Patent protections extend until at least 2028, delaying biosimilar competition.
Q2: What is the expected market share of pembrolizumab in oncology?
It maintains approximately 45%-50% of the immunotherapy market, with sustained growth expected through new indications.
Q3: How are international prices for pembrolizumab different?
European prices are typically 20-30% lower; emerging markets have significantly lower prices but limited access.
Q4: What factors could influence price declines?
Introduction of biosimilars, payer negotiations, and expanded generic competition.
Q5: What are the primary drivers of revenue for pembrolizumab?
Growing indications, increasing patient populations, and high reimbursement levels in key markets.
References
- IQVIA. (2022). Global Oncology Market Report.
- FDA. (2023). Approved Drug Label for Pembrolizumab (Keytruda).
- PhRMA. (2022). Biologic and Biosimilar Landscape.
- European Medicines Agency. (2023). Marketing Authorization for Pembrolizumab.
- U.S. Patent and Trademark Office. (2023). Patent Expiry Data.
