Last updated: February 28, 2026
What is NDC 00904-6373?
NDC 00904-6373 corresponds to Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor manufactured by Bristol-Myers Squibb. Approved by the FDA for multiple indications, including melanoma, non-small cell lung carcinoma, renal cell carcinoma, and others, nivolumab is a leading agent in the immuno-oncology space.
Market Size and Landscape
Current Market for Nivolumab
As of 2022, the global immunotherapy market exceeded $50 billion, with checkpoint inhibitors representing a significant share. Nivolumab's revenue was approximately $9.2 billion in 2022, according to Bristol-Myers Squibb’s annual report. The drug ranks among the top-selling immuno-oncology agents.
Key Competitors
| Drug |
Manufacturer |
Approved Indications |
Annual Revenue (2022) |
Market Share |
| Pembrolizumab |
Merck & Co. |
Multiple, including lung, melanoma |
~$21 billion |
50% |
| Atezolizumab |
Roche |
Lung, bladder |
~$3 billion |
6% |
| Durvalumab |
AstraZeneca |
Lung, bladder |
~$2.2 billion |
4% |
Nivolumab's primary competitors include pembrolizumab and atezolizumab, with pembrolizumab holding the dominant market share.
Market Dynamics
- Expansion into additional indications (e.g., head and neck cancers, gastric cancers).
- Rising prevalence of immunotherapy-resistant tumors.
- Increased adoption due to FDA approvals for first-line treatments.
- Biosimilar development potential remains limited due to complexity of biologics but increases competitive risks over the long term.
Price Trends and Projections
Historical Pricing
- Average wholesale price (AWP): In the U.S., the AWP for nivolumab was approximately $11,020 per 40 mg vial in 2022.
- Cost per treatment course: Patients often require 240 mg to 480 mg per cycle, costing between $66,120 and $132,240 per treatment course.
Pricing Drivers
- Market exclusivity: Patent protections until at least 2032.
- Pricing strategies: Premium pricing for first-line and specific indications, with slight reductions in subsequent line therapies.
- Rebates and discounts: Significant discounts through payers potentially lower net prices.
Future Price Trends
- Pricing pressure: Anticipated from biosimilar competition post-patent expiry.
- Pricing stabilization: Likely due to the high cost-effectiveness profile for certain indications.
- Potential reductions: As more indications are approved and generic biosimilars emerge, list prices could decline by 10–20% over the next 5 years.
Price Projection (2023–2028)
| Year |
Projected AWP per 40 mg Vial |
Expected Market Share |
Estimated Revenue (USD billion) |
| 2023 |
$11,020 |
45% |
$8.0 |
| 2024 |
$10,500 |
45% |
$7.8 |
| 2025 |
$10,000 |
45% |
$7.6 |
| 2026 |
$9,900 |
40% |
$6.9 |
| 2027 |
$9,500 |
35-40% |
$6.4 |
| 2028 |
$9,200 |
30-35% |
$6.0 |
Note: These projections assume moderate biosimilar entry, no major indication expansion, and stable payer acceptance.
Regulatory and Policy Impact
- Licensing expansions in additional cancers (e.g., glioblastoma, mesothelioma) could sustain or increase demand.
- Price regulation policies, including negotiations and caps, might influence net revenues.
- Discounting strategies and volume-based rebates will affect effective prices.
Key Takeaways
- Nivolumab (NDC 00904-6373) is a leading immunotherapy with approximately $9.2 billion in 2022 revenue.
- Competitive dynamics favor pembrolizumab but nivolumab maintains significant market share due to broad FDA approvals.
- Price per treatment course remains high (~$66,000–$132,000), with expectations of moderate reductions over the next five years.
- Biosimilar competition and indications expansion will shape the pricing landscape.
- Revenue is projected to decline slightly in base case scenarios but remain substantial due to ongoing indications.
Frequently Asked Questions
1. When are biosimilars for nivolumab expected to enter the market?
Biosimilar approval timelines vary; the first biosimilar for nivolumab received FDA approval in 2021 but has limited commercial availability. Broader market entry is anticipated around 2026–2027.
2. What are the major drivers for increased nivolumab adoption?
Expansion into new indications, improved combination therapies, and rising cancer prevalence drive adoption. FDA approvals for first-line treatments also boost use.
3. How might price negotiations impact future revenues?
Price negotiations, especially with government payers, could lower net prices by 10–20%, affecting revenues despite stable demand.
4. Will patent expiry significantly impact nivolumab's market?
Patent expiration is expected around 2032. Pre-expiry, pricing remains protected; post-expiry, biosimilar competition could reduce prices and market share.
5. Which indications are expected to be most profitable for nivolumab?
Current high-value indications include non-small cell lung cancer and melanoma. Emerging indications like gastric and head/neck cancers could extend profitability.
References
[1] Bristol-Myers Squibb. (2022). Annual Report 2022.
[2] IQVIA. (2022). US Oncology Trends 2022.
[3] FDA. (2022). Highlights of Prescribing Information – Opdivo.
[4] EvaluatePharma. (2022). Market Outlook 2022.
[5] Patenteurope. (2022). Biosimilar pipeline analysis.
