Last updated: February 20, 2026
What is the Drug Associated with NDC 00904-7417?
The National Drug Code (NDC) 00904-7417 corresponds to Keytruda (pembrolizumab), a PD-1 inhibitor developed by Merck. Approved initially in 2014, Keytruda is prescribed for multiple cancers, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and others.
Market Landscape Overview
Keytruda is a leading immune checkpoint inhibitor with a dominant market position. As of 2022, it holds the largest share among PD-1/PD-L1 inhibitors globally, surpassing competitors such as Opdivo (nivolumab) and Tecentriq (atezolizumab). The drug's key differentiator is its broad label approvals across numerous indications, including first-line treatment.
Market Size (2022-2023)
| Region |
Market Size (USD billion) |
Market Growth (CAGR 2022-2027) |
| United States |
9.2 |
10% |
| Europe |
3.8 |
8% |
| Asia-Pacific |
1.5 |
14% |
| Rest of World |
0.7 |
12% |
Total global revenue for pembrolizumab products approached USD 15 billion in 2022, reflecting its centrality in immuno-oncology.
Competitive Position
| Drug |
Market Share (2022) |
Indication Coverage |
Pricing Tier |
| Keytruda |
65% |
30+ indications, including front-line lung, melanoma |
Premium |
| Opdivo |
20% |
Major indications, including melanoma and lung |
Premium |
| Tecentriq |
10% |
Bladder, lung, and triple-negative breast cancer |
Premium |
The dominance of Keytruda is driven by its extensive approvals and robust safety profile. Its market share has remained stable despite increasing competition.
Price Projections and Cost Trends
Current Pricing Data
-
Average Wholesale Price (AWP): USD 10,000—USD 12,000 per 200 mg vial (as of 2023, varies by payer)
-
Per-Patient Cost (per cycle): USD 5,000—USD 16,000, depending on dosage and indication
Historical Price Trends
| Year |
Average Price (USD) per Vial |
Notes |
| 2014 |
USD 12,600 |
Launch price |
| 2018 |
USD 11,000 |
Price stabilization |
| 2022 |
USD 10,500 |
Slight decrease, competitive pressure easing |
Future Price Predictions (2023-2027)
Factors influencing price movements include:
- Market competition: Entry of biosimilars and new PD-1 inhibitors can pressure prices.
- Manufacturing costs: Slight reductions anticipated with process improvements.
- Regulatory and payer dynamics: Price negotiations, value-based pricing, and reimbursement policies.
Projected Average Vial Price (2025): USD 9,500—USD 10,500
Per-Patient Cost (2025): USD 4,750—USD 13,125
The pricing trend indicates modest downward pressure, with stabilization expected around USD 9,500 per vial by 2025, pending no major patent litigations or biosimilar launches in the US.
Regulatory and Patent Considerations
Keytruda's original composition patent expired in the US in 2028, but Merck has multiple formulation, method-of-use, and combination drug patents extending protection until at least 2030. Biosimilar entry in the US is anticipated between 2028-2030, potentially impacting pricing and market share.
Market Entry Barriers
- Regulatory hurdles: Extensive clinical studies required for biosimilar approval.
- Market dynamics: Existing payer contracts favor keytruda; switching costs are high.
- Intellectual property: Patent litigation can delay biosimilar availability.
Key Takeaways
- Keytruda commands a dominant share in the immuno-oncology market with USD 15 billion annual revenue.
- The global market is expected to grow at approximately 10% annually until 2027.
- Price per vial is projected to decline gradually, stabilizing around USD 9,500 by 2025.
- Biosimilar competition, patent expirations, and changing reimbursement policies will influence prices.
- Merck's strategic focus on expanding indications sustains its market position and revenues.
FAQs
1. What are the main factors affecting Keytruda pricing?
Market competition, biosimilar development, manufacturing costs, and payer negotiations influence pricing.
2. When are biosimilars expected to enter the US market?
Between 2028 and 2030, depending on patent litigation, regulatory approvals, and market conditions.
3. How does Keytruda’s market share compare to competitors?
It holds approximately 65% of the PD-1/PD-L1 inhibitor market in 2022, with competitors like Opdivo at 20%.
4. What is the primary driver for Keytruda’s revenue growth?
Expansion of approved indications and increased adoption in first-line treatment settings.
5. How might future regulatory changes impact pricing?
Stricter cost negotiations and value-based reimbursement policies could lead to further price reductions.
References
- IQVIA. (2023). Global oncology market data.
- Merck. (2022). Keytruda product label.
- EvaluatePharma. (2022). Oncology drug market trends.
- FDA. (2023). Biosimilar development and approval timelines.
- Center for Drug Evaluation and Research. (2022). Intellectual property and biosimilar pathways.
