Last updated: February 20, 2026
What Is NDC 50102-0228?
NDC 50102-0228 refers to a specific pharmaceutical product identified by the National Drug Code (NDC). Based on the NDC directory, this code corresponds to Nivolumab (Opdivo), an immune checkpoint inhibitor used primarily in oncology.
Market Overview
Indications and Approved Uses
Nivolumab targets PD-1 receptors to facilitate immune response against cancers. Approved indications include:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Hodgkin lymphoma
- Other solid tumors
Competitive Landscape
Key competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi). Market share is concentrated among these products, with Nivolumab holding a significant portion in several indications.
Sales Data
In 2022, global sales of Nivolumab reached approximately $7 billion, with U.S. sales accounting for roughly 60%. Florida-based Bristol-Myers Squibb (BMS) develops and markets Opdivo.
Market Drivers
- Expansion of approved indications
- Increasing prevalence of target cancers
- Adoption of immunotherapy as first-line treatment
- Cost-effectiveness driven by durable responses
Market Constraints
- High drug cost (~$150,000 per year per patient)
- Potential biosimilar entries
- Pricing pressures from payers
- Regulatory challenges
Price Analysis
Current Pricing
- List price per 40 mg vial: approximately $4,700
- Typical dosing: 240 mg every 2 weeks (approximate cost per dose: $28,200)
- Annual treatment cost for standard protocols: $300,000–$450,000 depending on dosing and duration
Reimbursement Landscape
Reimbursement varies significantly. Medicare, Medicaid, and private insurers negotiate discounts, rebates, or formulary premiums, often reducing the net price by 30–50%.
Price Trends
- Slight downward pressure over last three years
- Attempts to improve affordability through value-based pricing
- Biosimilar development expected to reduce prices by 20–30% per dose
Future Market and Price Projections
Market Growth Forecasts
- Compound annual growth rate (CAGR): 8% over 2023-2028
- Projected 2028 global sales: approximately $12 billion
- U.S. market share expected to stabilize at 60% of global sales
Price Trajectory
- Short-term: stable list prices but increased discounts and rebates
- Medium-term: biosimilar entry anticipated by 2025-2026 may lower prices 20–30%
- Long-term: patent expirations and competition could reduce prices by 25–50% over the next decade
Key Factors Influencing Price Changes
- Biosimilar approvals and market entry
- Policy reforms driven by cost control efforts
- Expansion of indications, potentially increasing volume but decreasing average price
- Manufacturer strategies, including value-based contracts
Summary Table
| Aspect |
Data |
Trend / Projection |
| Global sales (2022) |
~$7 billion |
Growing at 8% CAGR |
| U.S. sales (2022) |
~$4.2 billion |
Stable, dominant market share |
| List price per dose |
~$28,200 |
Slight decline expected upon biosimilar entry |
| Estimated biosimilar impact |
20–30% price reduction |
By 2026 |
| Additional discounts & rebates |
30–50% |
Ongoing trend |
Key Takeaways
- Nivolumab (NDC 50102-0228) is a leading immunotherapy with a significant market presence, driven by expanding indications.
- The drug commands high list prices but faces downward pricing pressure from biosimilars and payer negotiations.
- Sales are projected to grow at a mid-single-digit rate globally, with U.S. sales remaining dominant.
- Prices are expected to decline by up to half over the next decade due to biosimilar competition and policy measures.
- The competitive landscape emphasizes the importance of innovation, value-based pricing, and market expansion.
FAQs
1. When will biosimilars for Nivolumab enter the market?
Biosimilar approvals are anticipated around 2025-2026, depending on regulatory decisions and patent litigations.
2. How does the pricing of Nivolumab compare to its competitors?
Its list price is similar to pembrolizumab but generally higher than upcoming biosimilars. Actual net prices depend on discounts and rebates.
3. What is the primary driver for future price reductions?
The entry of biosimilars combined with cost-control policies drives downward pressure on prices.
4. Will increasing indications lead to higher overall sales despite price declines?
Yes, expanded indications may increase volume, offsetting price reductions and stabilizing revenue growth.
5. How are payers influencing the drug’s pricing and utilization?
Payers utilize formulary placements, prior authorization, and value-based contracts to control costs and ensure appropriate use.
References
- IQVIA. (2022). Pharmaceutical Market Reports.
- FDA. (2022). Biosimilar Product Approvals.
- Bristol-Myers Squibb. (2022). Opdivo Pricing and Market Data.
- MarketWatch. (2023). Immunotherapy Market Trends and Forecasts.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies and Pricing Data.
[Note: All data points are based on public industry sources and projections as of 2023.]
