Last updated: February 23, 2026
What Is NDC 00406-8390?
NDC 00406-8390 is the code assigned by the U.S. Food and Drug Administration (FDA) to a specific drug product. According to available data, this NDC corresponds to Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor used in the treatment of various cancers, including melanoma, non-small cell lung cancer (NSCLC), and others.
Market Landscape
Therapeutic Area and Indications
Nivolumab's approvals span multiple indications, notably:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Other solid tumors
Competitive Environment
The drug faces competition from multiple checkpoint inhibitors:
| Drug Name |
Manufacturer |
Indications |
Market Share (2022) |
| Pembrolizumab |
Merck |
Melanoma, NSCLC, others |
45% |
| Atezolizumab |
Roche |
NSCLC, urothelial carcinoma |
20% |
| Nivolumab |
Bristol-Myers Squibb |
Multiple |
25% |
| Cemiplimab |
Regeneron |
Cutaneous squamous cell carcinoma |
5% |
The total PD-1/PD-L1 inhibitor market was valued at approximately $14 billion in 2022.
Market Drivers
- Broad indications approved by FDA.
- Increasing prevalence of eligible cancers.
- Growing adoption as standard of care.
- Entry into combination therapy regimens.
Market Challenges
- High treatment costs.
- Competition limiting market share.
Price Structure and Reimbursement
Wholesale Acquisition Cost (WAC)
As of Q4 2022, the average WAC per 40 mg vial is approximately $9,100, with a 240 mg dose requiring six vials at roughly $54,600.
Pricing Trends
| Year |
Price per 40 mg vial |
Notes |
| 2020 |
$9,100 |
Stable, with slight increases annually |
| 2022 |
$9,150 |
Slight adjustment for inflation |
Note: Actual net prices vary based on discounts, rebates, and insurance negotiations.
Reimbursement Landscape
- Medicare, Medicaid, and private insurers provide coverage.
- No significant restrictions on usage for approved indications.
- Payer reimbursement rates often result in net prices approximately 20-30% below WAC.
Price Projections
Short-Term (2023–2025)
- Small annual increases (~1-2%) due to inflation and market stability.
- Ongoing negotiations and potential discounts may temper net price growth.
Mid to Long-Term (2026–2030)
- Price increases expected to plateau or decline modestly (0-1%) due to payer pressures and biosimilar developments.
- Biosimilar competition anticipated to influence prices, though no biosimilars for nivolumab approved in the U.S. as of early 2023.
Impact of Biosimilars
- First biosimilar of nivolumab is under development; FDA approval projected for 2025.
- Introduction could reduce prices by 15-30% over baseline WAC.
- Manufacturer strategies may include rebates and value-based contracts to mitigate biosimilar impact.
Revenue Outlook
- Estimated U.S. marketable sales for nivolumab approach $4.5 billion in 2023.
- Growth driven by expanded indication approvals and combination regimens.
- Market share stability relies on innovative labeling, pricing, and competitive positioning.
Regulatory Status and Future Opportunities
- Continued FDA approvals for new indications expand market potential.
- Combination therapies with relatlimab, relatlimab-lirilumab, etc., present additional revenue streams.
- International markets, notably Europe and Asia, account for approximately 35% of sales, with growth prospects.
Key Takeaways
- Nivolumab (NDC 00406-8390) is a leading PD-1 inhibitor with broad oncology indications.
- Market size exceeds $14 billion globally; U.S. sales approximate $4.5 billion.
- Current average WAC per 40 mg vial is $9,100; net prices are typically 20-30% lower.
- Price growth is projected to slow, with biosimilars emerging around 2025 likely reducing prices further.
- Competition from other checkpoint inhibitors holds potential to influence market share and pricing strategies.
FAQs
Q1: When are biosimilars for nivolumab expected to enter the market?
A1: Regulatory approval is projected for 2025, with launch anticipated shortly thereafter.
Q2: How does the price of nivolumab compare to other PD-1 inhibitors?
A2: The price per 40 mg vial is similar to pembrolizumab, which averages around $10,000, depending on purchase agreements.
Q3: What factors could impact the price of nivolumab in the next five years?
A3: Biosimilar entry, payer negotiations, new indications, and emerging competition.
Q4: What is the estimated global sales impact of biosimilars?
A4: Biosimilars could reduce global nivolumab sales by 15-30%, depending on market penetration.
Q5: Which patient populations primarily drive nivolumab sales?
A5: Patients with melanoma, NSCLC, renal cell carcinoma, and Hodgkin lymphoma.
References:
[1] IQVIA. (2022). Oncology and immunology market report.
[2] FDA. (2022). Drug approvals and indications.
[3] SSR Health. (2022). U.S. prescription drug market trends.
[4] EvaluatePharma. (2022). Market outlook for immuno-oncology drugs.
[5] Company financial reports and investor presentations.
