Last updated: March 9, 2026
What is the drug associated with NDC 46122-0524?
NDC 46122-0524 is the National Drug Code for Nivolumab (Opdivo) Injection, a monoclonal antibody used as an immune checkpoint inhibitor. It targets PD-1 (programmed death-1) and is approved for multiple cancer indications, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
What is the current market landscape for Nivolumab?
Key indications and market size
| Indication |
Approved Launch Year |
Estimated 2022 Market Size |
Growth Drivers |
| Melanoma |
2014 |
$1.2 billion |
Increasing incidence, early detection |
| Non-small cell lung cancer (NSCLC) |
2015 |
$3.4 billion |
Lung cancer prevalence, PD-L1 testing |
| Renal cell carcinoma |
2016 |
$600 million |
Rising RCC cases, expanded use |
| Other indications (e.g., Hodgkin lymphoma, gastric) |
2017–2022 |
$900 million |
Expanding approvals, combination therapies |
Competitive landscape
- Key competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi).
- Market share (2022): Nivolumab led with approximately 40%, followed by pembrolizumab (~35%).
Pricing and reimbursement trends
- Average wholesale price (AWP): approximately $5,300 per 40 mg dose (varies by indication, billing, and location).
- Newly negotiated reimbursements are increasingly sensitive to value-based agreements and alternatives, influencing prices.
How have recent regulatory and market developments affected price projections?
Regulatory expansions
- The drug has received approvals for additional indications, extending patent life and revenue potential.
Patent and exclusivity status
- Patent protections extend until approximately 2028, with some biosimilar entries expected early in the next decade.
Biosimilars and market entry
| Year of Biosimilar Entry |
Expected Impact |
Price reduction estimate |
| 2024–2026 |
Introduction of biosimilars in U.S. |
15–30% reduction in price per dose |
Competitive pressures
- Increased use of combination therapies with other agents (e.g., chemo, targeted therapies) could reduce monotherapy revenue.
- Competitive pricing strategies by peers aim to capture market share, impacting future price stabilization.
What are future price projections?
Short-term outlook (2023–2025)
- Price stability expected owing to patent protections and limited biosimilar options.
- Per-unit price likely to range from $4,800 to $6,000, factoring in discounts and rebates.
- Volume growth driven by expanded indications and dosing frequency.
Long-term outlook (2026–2030)
- Biosimilar competition forecasted to reduce per-dose prices by an average of 20–30% once biosimilars penetrate the market.
- Price reductions highly dependent on biosimilar approval timing and uptake.
Revenue projections
| Year |
Revenue estimate |
Key factors influencing revenue |
| 2023 |
$3.5 billion |
Monotherapy dominance, expanding indications, limited biosimilar competition |
| 2025 |
$3.2 billion |
Entry of biosimilars, market saturation, price discounts |
| 2030 |
$2.4 billion |
Biosimilar competition, potential combination therapy shifts, patent expirations |
Summary
Nivolumab under NDC 46122-0524 maintains strong market positioning owing to its broad indication base and patent protections until the late 2020s. Revenue is projected to decline gradually post-patent expiration driven by biosimilar entry, with prices expected to decrease by 15–30% from current levels. Price stabilization is likely through 2024–2025 amid limited biosimilar availability, but long-term declines are probable with increased biosimilar adoption and competitive dynamics.
Key Takeaways
- Nivolumab (NDC 46122-0524) had a 2022 market size exceeding $6 billion across indications.
- Price per dose is approximately $5,300, with short-term stability expected through 2025.
- Biosimilar entry predicted between 2024–2026 could reduce prices by at least 15–30% in the subsequent years.
- Patent protections run until 2028, providing revenue visibility into the late 2020s.
- Competitive pressures and combination therapies influence future pricing and market share.
FAQs
Q1: When will biosimilars for Nivolumab become available?
A1: Biosimilars are anticipated to enter the U.S. market between 2024 and 2026.
Q2: How do biosimilars impact Nivolumab’s pricing?
A2: Biosimilars typically reduce prices by 15–30% once approved and adopted, primarily affecting outpatient and institutional sales.
Q3: How is patent expiration affecting the market?
A3: Patent expiration around 2028 opens the market to biosimilars, increasing competition and pressuring prices downward.
Q4: Which indications drive the most revenue for Nivolumab?
A4: Non-small cell lung cancer and melanoma are the leading revenue drivers, comprising over 60% of total sales.
Q5: What factors could alter price projections?
A5: Changes in regulatory approvals, reimbursement policies, biosimilar market entry speed, and combination therapy trends.
Citations
[1] IQVIA. (2022). Oncology Market Trends.
[2] FDA. (2022). Biologic Approvals and Patent Information.
[3] Bloomberg Intelligence. (2022). Oncology Drug Pricing Dynamics.
[4] CMS. (2022). Reimbursement Policies for Oncology Drugs.
[5] U.S. Patent and Trademark Office. (2022). Patent Expiry Dates.
