Last updated: February 28, 2026
What is NDC 78206-0170?
NDC 78206-0170 corresponds to a specific formulation of Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor used primarily in oncology for treating cancers such as melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others.
Market Landscape Overview
Indications and Approved Uses
Nivolumab is approved for multiple indications, including:
- Melanoma
- NSCLC (previously used as a second-line, now approved as first-line in some cases)
- Small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Other tumor types
Market Size and Trends
The immuno-oncology market forms a segment with rapid growth. Key drivers include:
- Increasing incidence of cancers aligned with aging populations
- Broadening approved indications
- Growing adoption of immunotherapy as standard of care
In 2022, the global oncology immunotherapy market was valued at approximately $58 billion, expected to grow at a compound annual growth rate (CAGR) of 12% through 2027[1].
Competitive Landscape
Major competitors include:
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Durvalumab (Imfinzi)
Nivolumab holds a significant market share but faces pricing pressure due to competitive dynamics.
Patent and Regulatory Status
Key patents expired in the U.S. for Nivolumab in 2028; however, biologics tend to have longer exclusivity periods, and multiple biosimilars are under development.
Price Analysis
Current Pricing Structures
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Per-Procedure Cost: For nivolumab monotherapy, public payer prices are approximately $11,000 per 100 mg dose.
-
Average Treatment Course: Typically involves 4–6 cycles at 240 mg every two weeks, totaling approximately $44,000–$66,000 per patient.
-
Market Price Variability: Medicare Part B and private insurers tend to have different negotiated prices; average net prices are estimated around $8,000–$10,000 per 100 mg dose[2].
Price Trends and Projections
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Short-term (next 2 years): Prices are likely to stabilize or see slight reductions due to biosimilar entry and negotiations.
-
Mid to long-term (3-5 years): Prices may decline by 10–20%, assuming biosimilar approval and uptake, especially if patent exclusivity ends in 2028.
Biosimilar Impact
Though biosimilar versions are pending approval, their entry could decrease prices by 20–40%, similar to outcomes seen with other biologic drugs.
Price Drivers
- Patent outcomes
- Reimbursement policies
- Market competition
- manufacturing costs
Projections Summary
| Year |
Estimated Price per 100 mg Dose |
Comments |
| 2023 |
$8,000–$10,000 |
Existing market prices |
| 2024 |
$7,800–$9,800 |
Slight reductions |
| 2026 |
$7,000–$9,000 |
Biosimilar market influence |
| 2028+ |
$6,500–$8,000 |
Post-patent expiration |
Strategic Considerations
- Patent expiration in 2028: Prepare for biosimilar entry.
- Market share shifts: Align with evolving indications and combination therapies.
- Pricing negotiations: Engage with payers early to influence pricing.
Key Takeaways
- Nivolumab (NDC 78206-0170) is a leading immunotherapy with substantial current revenue.
- Market growth driven by expanding indications and cancer prevalence.
- Prices are high but likely to decline gradually due to biosimilars and competitive pressures.
- Price stabilization is expected through 2023–2024, with notable reductions possible post-2028.
- Companies should monitor biosimilar development and regulatory pathways closely.
FAQs
1. What factors influence nivolumab's price?
Pricing is affected by patent status, competition, manufacturing costs, payer negotiations, and biosimilar entries.
2. When will biosimilars for nivolumab impact prices?
Biosimilar applications are under review; anticipated approval could occur around 2028, corresponding with patent expiration.
3. How does nivolumab compare to competitors in price?
Prices are similar among immune checkpoint inhibitors; nivolumab is roughly $8,000–$10,000 per dose, comparable to pembrolizumab but with differences based on negotiated rebates.
4. What are the key markets for nivolumab?
The U.S., Europe, and emerging markets across Asia-Pacific are primary revenue sources, with the U.S. leading due to reimbursement infrastructure.
5. What is the outlook for nivolumab's market share?
It remains a top-performing immunotherapy but faces potential erosion post-2028 from biosimilars and new treatment modalities.
References
[1] Grand View Research. (2022). Oncology Immunotherapy Market Size & Trends Report.
[2] IQVIA. (2022). National Commercial and Medicare Price Data for Biologics.
