Last updated: February 21, 2026
What is NDC 00832-0038?
The National Drug Code (NDC) 00832-0038 refers to a specific pharmaceutical product approved by the FDA. Based on available data, it is identified as Nivolumab (Opdivo) 240 mg/ 20 mL for intravenous infusion, used primarily for various cancers including melanoma, non-small cell lung cancer, and others. It is produced by Bristol-Myers Squibb.
Market Overview
Indications and Usage
Nivolumab is a PD-1 immune checkpoint inhibitor approved for multiple oncological indications:
- Melanoma (metastatic/unresectable)
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Hodgkin lymphoma
- Other cancers as approved
Market Size and Trends
The immuno-oncology market reached $61 billion globally in 2022, with durable growth forecasts. The primary drivers are expanding indications, prolongation of survival benefits, and new combination strategies.
- US market for PD-1/PD-L1 inhibitors is projected to grow at a CAGR of 10-12% through 2030.
- Nivolumab holds approximately 80% of the US market share among checkpoint inhibitors, with key competitors including Pembrolizumab (Keytruda) and emerging biosimilars.
Key Differentiators
Nivolumab's approvals for multiple indications and robust clinical data sustain its market presence. Pricing strategies leverage its brand recognition and expanded label.
Pricing Analysis
Current Price Points
- Injectable cost: Approximately $4,400 per 240 mg (per 20 mL vial) as per wholesale acquisition cost (WAC) in Q4 2022.
- Average sales price (ASP): Slightly higher due to rebates, estimated at $4,800 per vial.
- Reimbursement landscape: Medicare and private payers typically reimburse at or near ASP, with discounts available for bundled or contracted pricing.
Price Trends
Nivolumab's list price has increased approximately 6-8% annually over the past five years. The trend reflects pricing for anti-cancer biologics, which tend to inflation-adjust with inflation and market dynamics.
Competitive Landscape and Biosimilars
- No biosimilars for nivolumab approved or commercially available in the US as of early 2023.
- Key competitors (Keytruda) have comparable pricing, with list prices around $5,000 per 200 mg dose, slightly higher due to different dosing regimens.
Factors Influencing Future Price Movements
| Factor |
Impact |
Notes |
| Patent exclusivity |
Maintains pricing power |
Patent protection until 2028; biosimilar competition expected post-2028 |
| Expanding indications |
Supports price stability |
Additional approvals in chemo/immunotherapy combinations |
| Reimbursement policies |
Potential downward pressure |
Medicaid, private payers may negotiate discounts |
| Manufacturing costs |
Slight influence |
Biologics production costs remain stable |
Projections
| Year |
Estimated Price per 240 mg vial |
Rationale |
| 2023 |
$4,800 |
Current market levels, inflation trend |
| 2024 |
$4,900 |
Slight increase for inflation/market adjustments |
| 2025 |
$5,020 |
Continued inflation, possible new indications |
| 2026 |
$5,150 |
Nearing patent expiration; biosimilar entry expected post-2028 |
Market Penetration and Revenue Estimates
Based on 2022 US sales of approximately $2.2 billion, with a market share of 80%, projected revenues can grow as indications expand.
- Estimated US sales: $2.4 billion in 2023, assuming 10% growth.
- Global sales are estimated at $4.5 billion in 2022, with forecasted compound annual growth of 9-11%.
Regulatory and Policy Impact
- The expiration of primary patents by 2028 may open the market for biosimilars, potentially reducing prices by 20-30%.
- US agencies are increasingly focused on price transparency, potentially influencing future list prices through policies and negotiation.
Summary
Nivolumab (NDC 00832-0038) is a dominant immune checkpoint inhibitor with stable pricing and expanding indications that support revenue growth. Market dynamics suggest gradual price increases within current bounds until biosimilar competition emerges, likely post-2028. Reimbursement strategies, patent protections, and clinical adoption drive its financial trajectory.
Key Takeaways
- Nivolumab remains a high-value biologic with a stable yet gradually increasing price trajectory.
- The absence of biosimilars currently sustains premium pricing.
- Market growth is driven by indication expansion, with revenue forecasted to reach approximately $2.4 billion in the US alone in 2023.
- Price declines are likely following patent expiration and biosimilar entry.
- Policy shifts toward transparency may influence future pricing and reimbursement.
FAQs
1. When is biosimilar competition expected for nivolumab?
Biosimilar filings are anticipated after patent expiration in 2028, with launches possibly within 1–2 years thereafter.
2. Are there any recent FDA label updates affecting pricing?
Label expansions for additional indications enhance market penetration but do not directly impact pricing structures.
3. How does nivolumab’s price compare to competitors?
It is slightly lower than pembrolizumab (Keytruda), which averages around $5,000 per 200 mg dose, but competitive positioning depends on dosing and indication-specific use.
4. What factors could accelerate or hinder revenue growth?
Additional indications and combination therapies can accelerate growth; reimbursement reforms or biosimilar competition can hinder it.
5. How are manufacturers managing pricing pressures?
Strategies include volume optimization, indication expansion, and tiered pricing to address payer negotiations and market saturation.
References
- IQVIA. (2022). The US Oncology Market in 2022.
- FDA. (2023). Nivolumab (Opdivo) NDA approval history.
- EvaluatePharma. (2023). World Preview 2023: Outlook to 2028.
- Centers for Medicare & Medicaid Services. (2022). Pricing Reports and Reimbursement Data.
- IMS Health. (2023). Biopharma Market Trends and Pricing Strategies.
