Last updated: February 20, 2026
What is the product associated with NDC 51407-0611?
NDC 51407-0611 refers to a biologic product, specifically Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor. It is used in oncology for multiple indications, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma.
Current Market Position and Indications
Opdivo is marketed by Bristol-Myers Squibb. As of 2023, it has secured approvals for over 10 indications globally, receiving broad commercial acceptance fueled by its eligibility for first-line and relapsed treatments across multiple cancers.
Market Size (2022-2023 Data)
| Parameter |
Value |
Source |
| Global oncology drug market |
$163 billion |
IQVIA[1] |
| Nivolumab sales (2022) |
$8.2 billion |
Bristol-Myers Squibb[2] |
| U.S. market share (2022) |
65% |
EvaluatePharma[3] |
| Indication growth (2022-23) |
12% |
Company reports |
Competitive Landscape
Primary Competitors:
- Pembrolizumab (Keytruda) – Merck
- Atezolizumab (Tecentriq) – Roche
- Durvalumab (Imfinzi) – AstraZeneca
Market dynamics:
Nivolumab competes primarily on efficacy, safety profile, and reimbursement coverage. Key differentiation points include its broad indication portfolio and established safety profile.
Pricing Benchmarks (U.S. Market)
| Drug |
Approximate Price per 40 mg Dose |
Notes |
| Nivolumab (Opdivo) |
$8,400 |
Average dose for melanoma (per infusion) |
| Pembrolizumab |
$7,700 |
Similar indication profile |
| Atezolizumab |
$7,200 |
Slightly lower across indications |
Prices vary based on dose and indication, typically ranging between $7,200 - $8,400 per 40 mg.
Price Projections and Trends
Short-term (Next 12-24 Months)
- Stable pricing trend: Due to high demand and continued indication approvals.
- Reimbursement negotiations: Will influence net price reductions, especially as biosimilars enter the market potentially in 2028, after BPCIA litigation concludes.
Long-term (Next 5 Years)
- Biosimilar impact: Entry of biosimilars for nivolumab could reduce prices by 20-30%, similar to patterns observed with other biologics such as Humira and Remicade.
- Indication extensions: Additional approvals, including adjuvant NSCLC, could support price stability or slight increases driven by label expansion.
| Year |
Estimated Price Range (per 40 mg) |
Notes |
| 2023-2025 |
$8,000 - $8,400 |
Current stable market prices |
| 2026-2028 |
$6,300 - $7,500 |
Biosimilar competition begins to affect prices |
| 2029+ |
$5,600 - $6,800 |
Increased biosimilar market penetration |
Market Penetration and Revenue Projections
| Year |
Estimated Global Revenue |
Key Drivers |
| 2023 |
$8.2 billion |
Existing indications, ongoing pipeline |
| 2025 |
$9.0 billion |
Expansion into new indications |
| 2028 |
$6.8 billion |
Biosimilar entry, price erosion |
| 2030 |
$5.8 billion |
Biosimilar proliferation, patent expirations |
Regulatory and Patent Landscape
- Patent Protection: Expected to expire in the U.S. around 2028-2029, opening market for biosimilars.
- Regulatory updates: Additional approvals in adjuvant and early-stage settings could extend revenue tailwinds into the next decade.
Key Takeaways
- Nivolumab (NDC 51407-0611) remains a dominant immunotherapy with high sales, driven by multiple indications.
- Prices in the U.S. average around $8,000 per 40 mg dose, with limited short-term change expected.
- Biosimilar competition anticipated post-2028 likely to reduce prices by up to 30%.
- Market expansion through label extensions and new indications could support stable or growing revenues through 2025.
- Price erosion from biosimilar entry and reimbursement adjustments will shape long-term profitability.
FAQs
Q1: How soon could biosimilars impact nivolumab prices?
A: Biosimilars are expected to enter the U.S. market around 2028, after patent expirations and regulatory approvals.
Q2: Are there any upcoming indications that could affect market size?
A: Yes, approvals for adjuvant NSCLC and combination regimens could expand market opportunities.
Q3: What are the main drivers for Opdivo's continued sales?
A: Broad indication coverage, combination therapies, and ongoing clinical trials support sales.
Q4: How do prices of nivolumab compare internationally?
A: Prices are typically lower outside the U.S., often by 20-40%, influenced by price controls and reimbursement policies.
Q5: What factors could sustain higher prices despite biosimilar entry?
A: Elevated demand for combination regimens, label extensions, and clinical advancements may maintain premium pricing for branded nivolumab.
References
[1] IQVIA. (2023). Market Analysis of Oncology Drugs.
[2] Bristol-Myers Squibb. (2023). Annual Financial Report.
[3] EvaluatePharma. (2023). Oncology Market Share Report.
