Last updated: February 23, 2026
What is NDC 46122-0700?
NDC 46122-0700 identifies a proprietary drug product. Based on available databases, this code corresponds to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor used in cancer immunotherapy. It is indicated for multiple cancer types, including melanoma, non-small cell lung cancer, and renal cell carcinoma, with formulations typically delivered via intravenous infusion.
Market Landscape
Current Market Adoption
- Indications: Approved for 10+ cancer types by FDA, including melanoma, lung, and kidney cancers.
- Market Dynamics: Nivolumab led the PD-1/PD-L1 inhibitor segment, with top competitors including Pembrolizumab (Keytruda) and Atezolizumab (Tecentriq).
- Market Size (2022): Estimated global revenue reached $13.3 billion; North America contributed approximately 60%, reflecting high adoption in the U.S.
- Prescriptions: The drug saw around 2.5 million prescriptions globally in 2022, reflecting widespread use across oncology centers.
Competitive Environment
| Drug Name |
Company |
Indications |
Market Share (2022) |
Notable Features |
| Nivolumab (Opdivo) |
Bristol-Myers Squibb |
Melanoma, NSCLC, RCC, others |
~45% |
First approved PD-1 inhibitor |
| Pembrolizumab |
Merck |
Multiple cancers |
~40% |
Versatile label, high sales |
| Atezolizumab |
Roche-Genentech |
Bladder, lung |
~10% |
Combination therapy options |
Pricing Overview
- Wholesale Acquisition Cost (WAC): Approx. $5,300 - $6,400 per 40 mg vial, varying by supplier and region.
- Average Treatment Cost: Estimated at $120,000 - $180,000 per patient annually, influenced by dosage and treatment duration.
- Reimbursed Price: Medicaid, Medicare, and private insurer negotiated prices are typically 10-20% lower than WAC.
Price Projection Factors
Regulatory and Policy Influences
- Patent Expiry: Nivolumab's primary patents expire in the U.S. in 2028-2030; biosimilars expected thereafter.
- Pricing Regulations: U.S. initiatives to control drug costs may influence future reimbursement and list prices.
- Biosimilar Entry: Pending biosimilar approvals could lead to price reductions of 20-40% within 3-5 years post-approval.
Market Penetration and Growth
- Expansion into New Indications: Ongoing trials for liver, gastric, and head-and-neck cancers could expand the label, increasing market size.
- Patient Population: Rising incidence rates of targeted cancers project a compounded annual growth rate (CAGR) of approximately 8% in the immunotherapy segment.
- Adoption Trends: Uptake in developing markets grows, although at a slower rate, individual pricing influences.
Pricing Trajectory (2023–2027)
| Year |
Expected WAC per 40 mg Vial |
Estimated Annual Revenue |
Key Drivers |
| 2023 |
$6,000 |
$3.2 billion |
Continued market dominance |
| 2024 |
$5,800 |
$3.4 billion |
Patent expiry warnings, biosimilar competition |
| 2025 |
$5,500 |
$3.6 billion |
Biosimilar launches, indication expansion |
| 2026 |
$5,200 |
$3.8 billion |
Market saturation, negotiated discounts |
| 2027 |
$5,000 |
$4.0 billion |
Biosimilar competition, volume growth |
Forward-Looking Considerations
- Price declines are likely post-biosimilar entry, but market share may stabilize or grow with label expansion.
- Price negotiations at the payer level could reduce net prices more rapidly than projections suggest.
- The trend toward value-based pricing and outcomes-based arrangements may impact average prices.
Key Takeaways
- Nivolumab (NDC 46122-0700) remains a leading agent in immunotherapy with expanding indications.
- Current list prices are approximately $5,300 - $6,400 per 40 mg vial; treatment costs exceed $150,000 annually.
- Market growth is driven by label expansion, rising cancer incidences, and broader adoption in emerging markets.
- Price declines of 20-40% are anticipated within 3-5 years following biosimilar entry and increased competition.
- Healthcare policy changes and biosimilar development remain the primary risk factors influencing future pricing.
FAQs
Q1: How does the patent expiration affect pricing?
Patent expiration in 2028-2030 is expected to introduce biosimilars, potentially reducing prices by 20-40%.
Q2: What are the main competitors for Nivolumab?
Pembrolizumab (Keytruda) and Atezolizumab (Tecentriq) are the principal competitors, with comparable indications and similar pricing.
Q3: How much does Nivolumab cost per patient annually?
Estimated between $120,000 and $180,000, depending on dosing, treatment duration, and patient weight.
Q4: Are biosimilars a threat to current prices?
Yes. Biosimilars are projected to enter the market post-2028, exerting downward pressure on prices.
Q5: What factors influence future price changes?
Regulatory policies, biosimilar approvals, indication expansion, and negotiated discounts drive future pricing trends.
References
[1] IQVIA. (2022). 2022 Global Oncology Market Data.
[2] FDA. (2023). Nivolumab (Opdivo) approval details.
[3] GoodRx. (2023). Nivolumab pricing and cost analysis.
[4] Evaluate Pharma. (2023). Oncology drugs’ market forecasts.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement policies for biologics.
