Last updated: February 27, 2026
What is NDC 72319-0696?
NDC 72319-0696 refers to a specific drug product listed in the National Drug Code database, which tracks drug manufacturers and packaging. Based on available data, this NDC code corresponds to Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor used primarily for oncology indications.
Market Overview
Therapeutic Indications and Market Size
Nivolumab is approved for various cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and Hodgkin lymphoma. Its broad approval scope ensures consistent demand across multiple oncology segments.
Estimations place the global oncology immunotherapy market at approximately US$ 47 billion in 2022, growing at a compound annual growth rate (CAGR) of 9.2%. Nivolumab is a core product, capturing roughly 25-30% of this segment, translating to approximately US$ 11.75-14.1 billion in annual revenue.
Competitive Landscape
Main competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), durvalumab (Imfinzi), and a host of biosimilars in development.
| Drug |
Market Share (2022) |
Key Indications |
Annual Revenue (est.) |
| Nivolumab |
25-30% |
Melanoma, NSCLC, RCC, HL |
US$ 11.75-14.1 billion |
| Pembrolizumab |
40-45% |
Multiple cancers, PD-L1 high |
US$ 18-21 billion |
| Atezolizumab |
10-15% |
Bladder, lung cancers |
US$ 4.7-7 billion |
Distribution and Reimbursement
In 2022, reimbursement for nivolumab remains stable in the U.S. via Medicare, Medicaid, and private insurers, driven by its approval across high-prevalence indications like NSCLC.
Price Projections
Current Pricing
The average wholesale price (AWP) for a 240 mg vial of nivolumab in the U.S. is approximately US$ 4,200. Pricing can vary by distributor, insurance coverage, and negotiated discounts.
Short-Term Trends (Next 1-2 Years)
Prices are expected to stabilize or slightly decrease due to increased biosimilar competition and negotiated discounts. A 3-5% reduction annually is projected, driven by biosimilar entrance and market saturation.
Long-Term Forecasts (3-5 Years)
Biosimilar market entry, beginning around 2024-2025, is anticipated to induce a price decline of 15-25%. These biosimilars are projected to retail at 60-70% of the originator price, i.e., US$ 2,500-2,800 per 240 mg vial.
Factors Influencing Price Trends
- Biosimilar Competition: Multiple companies developing nivolumab biosimilars, with FDA filings expected by 2023-2024.
- Regulatory Policies: Pricing reforms and increased use of value-based pricing.
- Patent Expirations: Patent cliff for primary formulations starting in 2024, enabling biosimilar proliferation.
- Market Penetration Strategies: Price discounts to secure formulary placement.
Regulatory and Patent Landscape
Nivolumab's primary patents expire in the U.S. in 2024, allowing biosimilar entry. The FDA has approved several biosimilar candidates, including:
- Celltrion's CT-P39 (expected approval 2024)
- Coherus Biosciences' CHS-1700 (under review)
- Samsung Bioepis' SB11 (under review)
Patent litigations have delayed biosimilar launches in select markets, but the overall trend favors increased competition.
Market Growth Drivers and Barriers
Drivers:
- Increasing cancer prevalence
- Growing adoption of immunotherapy
- Expanded indications
Barriers:
- High development costs for biosimilars
- Reimbursement hesitancy
- Patent litigations delaying biosimilar launches
Key Takeaways
- Nivolumab (NDC 72319-0696) commands a substantial oncology market share.
- The global oncology immunotherapy segment exceeds US$ 47 billion in 2022.
- Current pricing for nivolumab is around US$ 4,200 per 240 mg vial.
- Biosimilar entry from 2024 is expected to reduce prices by 15-25% over the next 3-5 years.
- Market growth hinges on expanding indications and biosimilar competition, balanced against patent expirations.
FAQs
1. When will biosimilars for nivolumab become available in the U.S.?
Biosimilars are expected to gain FDA approval starting from 2024, with market entry contingent on patent litigation and approval processes.
2. How will biosimilar entry impact pricing?
Prices are likely to decline by 15-25%, aligning biosimilar prices at approximately US$ 2,500-2,800 per 240 mg vial.
3. Which indications drive the most revenue for nivolumab?
Non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma account for the majority of sales.
4. What are the main competitors to nivolumab?
Pembrolizumab (Keytruda) leads, with atezolizumab, durvalumab, and biosimilars following.
5. How is the market expected to grow over the next five years?
The oncology immunotherapy sector is projected to grow at a CAGR of around 9.2%, with nivolumab remaining a significant contributor.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2023). Biosimilar Development and Approval.
[3] EvaluatePharma. (2023). World Market Forecasts: Oncology Immunotherapies.
[4] Pharma Intelligence. (2022). Immunotherapy Competitive Analysis.
