Last updated: February 25, 2026
What Is NDC 65862-0083?
NDC 65862-0083 refers to a specific pharmaceutical product registered with the National Drug Code (NDC) system. This code corresponds to Nivolumab (Opdivo) 240 mg, powder for concentrate for solution. It is an immune checkpoint inhibitor used primarily for oncology indications, including non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma.
Market Overview
Market Size and Growth
The global oncology drug market, including immunotherapies like Nivolumab, is projected to reach approximately $229 billion by 2027, with a CAGR of 8.5% from 2020 to 2027 (Fortune Business Insights, 2021). Nivolumab remains a leading product within this segment due to expanding indications and ongoing clinical trials.
Key Competitors
| Drug Name |
Mechanism |
Indications |
Market Share (2022) |
| Nivolumab |
PD-1 immune checkpoint inhibitor |
Melanoma, NSCLC, RCC, Hodgkin lymphoma |
Approximately 35% |
| Pembrolizumab |
PD-1 inhibitor |
Similar to Nivolumab |
Approximately 30% |
| Atezolizumab |
PD-L1 inhibitor |
Lung cancer, bladder, others |
Approximately 10% |
Prescription Trends
- In the U.S., Nivolumab prescriptions increased by 14% year-over-year (IQVIA, 2022).
- Off-label usage accounts for roughly 15% of prescriptions, influencing overall revenue.
Regulatory and Reimbursement Environment
- FDA approvals extend to combinational regimens, increasing its market applicability.
- Medicare and private insurers reimburse Nivolumab at prices with average compendial list prices around $14,000 per 240 mg dose (ASCO, 2022).
Price Dynamics and Projections
Current Pricing
| Pricing Aspect |
Details |
| List Price (per 240 mg dose) |
$14,000 |
| Average Selling Price (ASP) |
$12,500 (estimated; varies by provider) |
| Reimbursement Rate |
Up to 100% subject to insurance policies |
Influencing Factors
- Patent status: Active patents until at least 2028 inhibit generic competition.
- Biosimilar entry: FDA-approved biosimilars are expected from multiple competitors by 2025, which could reduce prices by 20-40%.
- Market expansion: Indications beyond approved uses (e.g., new tumor types) could sustain or increase prices.
- Manufacturing costs: Economies of scale lower production costs, potentially stabilizing pricing even amid biosimilar competition.
Price Projection Scenarios (2023-2028)
| Year |
Base Case Price |
Price with Biosimilar Competition |
Price with Expanded Indications |
| 2023 |
$14,000 |
$11,200 (20% reduction) |
$14,000 |
| 2024 |
$13,800 |
$10,400 (26% reduction) |
$14,000 |
| 2025 |
$13,500 |
$8,400 (40% reduction due to biosimilars) |
$13,800 |
| 2026 |
$13,200 |
$8,400 |
$13,800 |
| 2027 |
$12,900 |
$8,400 |
$13,800 |
| 2028 |
$12,500 |
$8,400 |
$13,800 |
Strategic Insights
- Biosimilar impact expected to prompt steep price reductions starting in 2025.
- Expansion of approved indications can sustain revenues despite biosimilar entry.
- Price erosion from biosimilars will pressure profit margins but could facilitate broader market access.
Key Takeaways
- NDC 65862-0083 (Nivolumab 240 mg) is a leading immunotherapy module with a growing market.
- Current list pricing remains around $14,000 per dose, with ASPs slightly lower.
- Patent exclusivity supports pricing through 2028, with biosimilar competition likely to induce a 20-40% price reduction from 2025 onward.
- Market expansion into new cancer indications could sustain value amid biosimilar entry.
- Insurance reimbursement practices significantly impact actual treatment costs represented in the market.
FAQs
1. How will biosimilar approval influence Nivolumab's pricing?
Biosimilars' regulatory approval typically leads to price reductions of 20-40%. Competition may push list prices downward, but existing patents provide a window of pricing stability until around 2028.
2. Are there cost advantages for healthcare providers with biosimilars?
Yes. Biosimilars often cost 20-30% less than originators, reducing treatment expenses and increasing accessibility.
3. Which indications will likely expand Nivolumab’s market share?
Expansions into gastrointestinal cancers, head and neck cancers, and combination regimens with chemotherapy are increasing usage.
4. What is the impact of reimbursement policies on Nivolumab prices?
Reimbursement rates influence providers' actual costs and patient access, indirectly impacting the market-price dynamics.
5. How long can Nivolumab maintain premium pricing?
Patent exclusivity until at least 2028, combined with expanding indications, supports premium pricing until bioscalars are broadly available.
References
- Fortune Business Insights. (2021). Oncology Drugs Market Size, Share & Industry Analysis, 2020-2027.
- IQVIA. (2022). Prescription drug market trends report.
- American Society of Clinical Oncology (ASCO). (2022). Drug pricing and reimbursement data.
