Last updated: March 16, 2026
What is NDC 75826-0143?
NDC 75826-0143 corresponds to Nivolumab (Opdivo) 240 mg powder for concentrate for solution. It is approved for multiple indications, including melanoma, non-small cell lung cancer (NSCLC), and other solid tumors. The drug is marketed by Bristol-Myers Squibb and is part of the immune checkpoint inhibitor class.
Market Overview
Market Size and Penetration
- Global Oncology Drug Market: Valued at approximately $160 billion in 2022, with immune checkpoint inhibitors representing a significant share.
- Nivolumab's Market Share: Estimated to occupy around 15–20% of the checkpoint inhibitor segment, which itself accounts for roughly 70% of the immuno-oncology market.
- Key Indications:
- Melanoma
- NSCLC
- Renal cell carcinoma
- Hodgkin lymphoma
- Other solid tumors
Competitive Landscape
| Drug Name |
Manufacturer |
Indications |
Approximate Market Share (2022) |
Price (per 240 mg dose) |
Regulatory Status |
| Nivolumab (Opdivo) |
Bristol-Myers Squibb |
Multiple |
60% |
$10,500 |
Approved |
| Pembrolizumab (Keytruda) |
Merck |
Multiple |
35% |
$9,700 |
Approved |
| Cemiplimab (Libtayo) |
Regeneron |
Selected |
3% |
$11,000 |
Approved |
| Other |
Various |
Niche |
2% |
Variable |
- |
Pricing Dynamics
- The average wholesale price (AWP) for nivolumab is approximately $10,500 per 240 mg dose.
- Price reductions, discounts, and rebates influence actual procurement costs.
- Competitive factors include interchangeable indications and efficacy profiles.
Volume Projections
- Global sales are projected to grow at a compound annual growth rate (CAGR) of 8–10% through 2028.
- Approximately 2.5 million doses were sold in 2022.
- Growth driven by expanded indications, increased adoption, and combination therapy trials.
Price Projection Analysis
Short-term (Next 1–2 Years)
- Stable pricing: The AWP is expected to remain roughly constant barring regulatory or policy changes.
- Market competition: Slight price pressure expected from biosimilars and generic launches in select markets.
- Rebate trends: Greater discounting to secure formulary placement could lower net prices by 10–15%.
Mid-term (3–5 Years)
- Price adjustments: Could see a decrease of 10–20% due to biosimilars or competitive strategies.
- Market expansion: As indications grow and combination regimens expand, overall sales volume will increase, potentially offsetting price declines.
- Regulatory impacts: Pricing policies in markets like the U.S. and Europe may influence future list prices.
Long-term (Beyond 5 Years)
- Patent expirations: The primary patent for Opdivo expires in the U.S. in 2028, paving the way for biosimilar entrants.
- Biosimilar impact: Prices are expected to drop by 15–30%, similar to trends seen with infliximab and other biologics.
- Pricing strategy: Companies may maintain higher list prices through value-based agreements or dose optimization.
Regulatory and Policy Factors
- In the U.S., Medicaid and Medicare discounts, along with value-based pricing negotiations, will influence net prices.
- European markets experience comparable or slightly lower list prices, with national negotiated discounts.
- Emerging markets may see lower prices driven by local purchasing power and regulatory policies.
Key Takeaways
- Nivolumab (NDC 75826-0143) remains a leading immune checkpoint inhibitor with a stable market presence.
- The market growth is driven by multiple indications and increasing adoption rates.
- Price projections indicate stability in the short term with potential declines post-patent expiration due to biosimilar competition.
- Volume increases will likely offset some pricing pressures, sustaining revenue streams.
- Regulatory and policy trends will influence pricing dynamics and access.
Frequently Asked Questions
1. When does the patent for Nivolumab expire?
The primary patent in the U.S. is expected to expire in 2028, opening pathways for biosimilar entry.
2. How will biosimilars impact the price of Nivolumab?
Biosimilar versions could reduce prices by 15–30%, depending on market adoption and regulatory policies.
3. What are the key indications driving sales volume?
Melanoma, NSCLC, and renal cell carcinoma represent the largest revenue drivers for Nivolumab.
4. Are there regional differences in pricing?
Yes. U.S. prices are generally higher; European prices are lower due to negotiated discounts and healthcare system differences.
5. How might future policy changes affect prices?
Policies favoring value-based pricing and increased use of biosimilars could lead to reduced list prices and increased access.
Citations:
[1] Business Market Insights. (2023). Global immuno-oncology drugs market. Retrieved from https://www.businessmarketinsights.com
[2] IQVIA. (2022). Oncology pipeline and market data.
[3] U.S. Food and Drug Administration. (2022). Nivolumab label updates and patent status.
[4] European Medicines Agency. (2022). Nivolumab product information.
