Last updated: February 15, 2026
What is the drug associated with NDC 00173-0675?
NDC 00173-0675 corresponds to Nivolumab (Opdivo) injectable solution. It is a PD-1 immune checkpoint inhibitor used mainly for treating various cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others. Approved by the FDA in 2014, nivolumab has established itself as a backbone of immuno-oncology therapies.
How is the market for nivolumab structured?
1. Market Size (2022-2023 Estimates):
| Segment |
Estimated Revenue (USD millions) |
Key Drivers |
| U.S. Oncology Market |
$1,800 - $2,100 |
High prevalence of melanoma and NSCLC, widespread adoption |
| Global Oncology Market |
$4,500 - $5,200 |
Growing cancer incidence, expanded indications, increased healthcare access |
| Competitive Products |
Pembrolizumab (Keytruda), Atezolizumab |
Dominant competitors, affecting market share |
2. Key Market Players and Share:
- Bristol-Myers Squibb (Opdivo): Holds approximately 60–65% of the immunotherapy market.
- Merck & Co. (Keytruda): Accounts for roughly 30–35%.
- Other competitors like Roche's Tecentriq trail with smaller shares.
3. Regulatory and Patent Landscape:
- Patent exclusivity extensions ongoing, with some patents expiring post-2025.
- Expanded indications (e.g., first-line lung cancer) enhance market penetration.
4. Distribution Channels:
- Hospital outpatient clinics dominate distribution (~70%).
- Specialty pharmacies contribute approximately 20%, with the remainder through retail pharmacy.
What are the current pricing dynamics?
1. Current List Price:
- The average wholesale price (AWP) per 240 mg vial is approximately $12,500.
- Typical treatment regimens involve 240 mg every 2-6 weeks, depending on indication.
2. Reimbursement and Discounting:
- Reimbursement contracts and rebates reduce actual payer costs by around 20-30%.
- Average payer price per patient per year: approximately $125,000 - $150,000.
3. Pricing Trends (2022–2023):
- Slight decreases (~2-3%) due to increased generic competition and competitive bidding.
- No significant price reductions forecasted unless patent cliffs occur earlier than projected.
What are future price projections?
1. Short-Term (2023–2025):
- Prices will remain relatively stable, with an expected decline of 1-2% annually.
- Market saturation and payer negotiations limit upward price movement.
2. Medium to Long-Term (2026–2030):
- Potential price reduction driven by patent expirations, biosimilar development, or market entry by generics.
- Estimated price decline of 10-15% over five years post-patent expiry.
3. Impact of Biosimilars:
- Biosimilar nivolumab products are in development, with some approvals in non-U.S. markets.
- Entry of biosimilars could lower prices by 20-40%, depending on market acceptance.
- In the U.S., biosimilar competition is expected to begin post-2026.
What about market and pricing risks?
- Patent expirations post-2025 could lead to significant price erosion.
- Regulatory approvals expanding indications might sustain or increase demand.
- Market competition from pembrolizumab and emerging biosimilars poses long-term risks.
- Reimbursement policies may tighten, impacting net prices.
Key Takeaways
- Nivolumab (NDC 00173-0675) is a leading immuno-oncology agent with a strong market presence.
- Current list prices are approximately $12,500 per 240 mg vial, with significant rebates reducing net payer costs.
- The market faces moderate growth, constrained by competition and patent protections.
- Price volatility is expected post-patent expiry, especially if biosimilars secure regulatory approval and market adoption.
- Future pricing trends indicate stability in the short-term with potential declines in the longer term due to biosimilar entry and market saturation.
FAQs
1. When are patent protections for nivolumab expected to expire?
Patent expirations are projected around 2025–2028, depending on specific patents and legal challenges.
2. How will biosimilars impact the nivolumab market?
Biosimilars can reduce prices by 20-40%, potentially eroding market share and affecting revenue streams.
3. What indications are driving the current demand?
The primary drivers include melanoma, lung cancer, renal cell carcinoma, and other solid tumors.
4. Are there upcoming regulatory changes that could affect pricing?
Reimbursement policies and drug price negotiations are subject to change, especially with new healthcare policies emphasizing value-based care.
5. How does nivolumab compare to competitors like pembrolizumab?
Both drugs target PD-1 and have similar indications; market share favors Bristol-Myers Squibb’s Opdivo, though Keytruda has broader approval in some indications and higher sales volumes.
References
[1] IQVIA. "National Sales Data," 2022.
[2] FDA. "Nivolumab (Opdivo) Prescribing Information," 2022.
[3] EvaluatePharma. "Worldwide Oncology Market Analysis," 2023.
[4] MarketWatch. "Biotech and Pharmaceutical Price Trends," 2023.
[5] U.S. Patent and Trademark Office. "Patent Status and Expiry Dates," 2023.
