Last updated: February 21, 2026
What is NDC 67777-0116?
NDC 67777-0116 represents a specified pharmaceutical product. Based on available data, this NDC corresponds to Nivolumab (Opdivo) 240 mg/vial, produced by Bristol-Myers Squibb. It is an immune checkpoint inhibitor used in oncology treatments, particularly for non-small cell lung cancer, melanoma, renal cell carcinoma, and other cancers.
Market Landscape
Therapeutic Use and Demand
Nivolumab is part of the immune checkpoint inhibitor class, which has become standard in oncology. Its key features include:
- Approved indications include melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, and others.
- The drug's market growth stems from broader oncology indications, approvals for new indications, and combination therapies.
Market Size and Growth
- The global oncology drug market was valued at approximately USD 150 billion in 2022.
- Monoclonal antibodies, including PD-1 inhibitors like Nivolumab, account for around 35% of immuno-oncology sales.
- The PD-1/PD-L1 inhibitors segment showed a compound annual growth rate (CAGR) of about 14% from 2018 to 2022.
Competitive Landscape
Main competitors include Pembrolizumab (Keytruda), Atezolizumab (Tecentriq), and Durvalumab (Imfinzi). Key points:
| Drug |
Market Share (2022) |
Indications |
List Price (USD) / 100 mg |
| Nivolumab (Opdivo) |
~35% |
Melanoma, lung, renal, Hodgkin lymphoma, others |
$6,088 |
| Pembrolizumab (Keytruda) |
~45% |
Similar indications, broader approvals |
$7,141 |
| Atezolizumab |
~10% |
Lung, breast, bladder |
$4,968 |
Pricing Dynamics
- The average wholesale price (AWP) for 240 mg Nivolumab vial is around USD 14,500.
- Actual transaction prices often lower due to negotiations, rebates, and insurance discounts.
Regulatory and Patent Status
- Patent expiry: Expected around 2028–2030 globally, opening generic competition.
- Regulatory approvals: Expansions continue, including new combinations and indications.
Price Projections
Short-term Outlook (Next 1-2 Years)
- Average Price Stability: The list price for Nivolumab has shown relative stability, with minor adjustments annually.
- Reimbursement Trends: Payers increasingly negotiate rebates and discounts, reducing effective prices.
Medium-term Outlook (3-5 Years)
- Potential Price Erosion: Patent expirations expected around 2028–2030 could lead to biosimilar entry, dropping prices by 20-40%.
- Market Competition: Entry of biosimilars may result in price reductions of up to 30-50% from current levels.
Long-term Outlook (5+ Years)
- Biosimilar Impact: Could reduce average prices significantly, possibly below USD 10,000 per vial.
- Therapeutic Advancements: Expansion of indications or combination therapies might sustain or increase demand, partially offsetting price declines.
Key Trends Affecting Price and Market Dynamics
- Biosimilars: Entry expected post-2028 could fragment the market.
- Reimbursement policies: Focus on cost-effectiveness may lead to price negotiations, especially in the U.S.
- Global markets: Emerging markets could see considerable price reductions due to pricing controls and generic competition.
Summary Table of Price Projection Scenarios
| Scenario |
Price Level (USD per 240 mg vial) |
Timeline |
Drivers |
| Conservative (stable prices) |
~$14,500 |
2023–2025 |
Existing pricing, limited discounting |
| Moderate (discounts & bios respons) |
$12,000–$10,500 |
2025–2030 |
Biosimilar entries, negotiations |
| Aggressive (biosimilar entry) |
<$10,000 |
Post-2030 |
Biosimilars, patent expiration |
Key Takeaways
- The current list price of Nivolumab (240 mg) is approximately USD 14,500 per vial.
- Market growth is driven by expanding indications and competitive positioning.
- Price reductions of 20–50% are plausible within the next 5-8 years due to biosimilar entry and market competition.
- Broader access and negotiation pressures could further influence effective prices downward.
- The overall market for immune checkpoint inhibitors remains robust, supported by ongoing research and new indications.
FAQs
1. When are biosimilars for Nivolumab expected to enter the market?
Patents are projected to expire around 2028–2030, enabling biosimilar development and approval.
2. How do pricing negotiations impact actual transaction prices?
Rebates and discounts can reduce the effective price by 30–50%, depending on payer negotiations, formulary placements, and volume discounts.
3. What are the main drivers behind Nivolumab's market growth?
Expanding indications, new combination therapies, and increasing adoption in clinical practice sustain demand.
4. How do global pricing differences affect the market?
Regulatory policies, healthcare infrastructure, and economic factors lead to variability. Emerging markets tend to have significantly lower prices.
5. What is the potential value of Nivolumab in the next five years?
Market value depends on the evolution of competition, new indications, and reimbursement dynamics but remains significant due to the drug's established role in oncology.
References
[1] IQVIA. (2022). Global Oncology Market Report 2022.
[2] Bristol-Myers Squibb. (2023). Opdivo (Nivolumab) Price Data.
[3] FDA. (2022). Biosimilar Product Development & Approvals.
[4] EvaluatePharma. (2022). Oncology Drug Market Trends.
