Last updated: March 8, 2026
What is NDC 00591-5543?
NDC 00591-5543 identifies Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor used for treating various cancers, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma. Approved by the FDA, this drug is marketed by Bristol-Myers Squibb.
Market Overview
Market Size and Dynamics
Nivolumab reached global sales of approximately $8.2 billion in 2022, reflecting a growth rate of 12% year-over-year (Bristol-Myers Squibb, 2023). The demand for immune checkpoint inhibitors (ICIs) drives this expansion, with nivolumab holding a substantial share of the ICI market.
Competitive Landscape
Key competitors include Pembrolizumab (Keytruda), Atezolizumab (Tecentriq), and Durvalumab (Imfinzi). Key factors influencing market share include efficacy, safety profiles, and approved indications. Key competitors' sales:
- Keytruda: ~$14.4 billion in 2022
- Tecentriq: ~$1.9 billion in 2022
- Imfinzi: ~$1.6 billion in 2022
Regulatory Developments & Expandability
Recent approvals expand nivolumab's indication portfolio, including combinations with other agents for novel indications such as gastric, head and neck, and bladder cancers. These expansions have potential to boost revenue.
Price Analysis
Current Pricing
As of Q1 2023, the average wholesale price (AWP) for nivolumab is approximately $4,750 per 100 mg vial. The treatment course varies by indication, typically requiring doses between 240 mg and 480 mg every 2–4 weeks.
Cost Drivers
Pricing is influenced by:
- Manufacturing complexity
- Patent protections (expire around 2032)
- Competitive pricing strategies
- Reimbursement and negotiations with payers
Price Trends
Since FDA approval in 2014, nivolumab's list price has increased modestly by approximately 3-4% annually, aligned with inflation and market factors. No significant discounts or biosimilars are currently available in the US.
Projections
Mid-Term (Next 3-5 Years)
- Expected revenue growth rates: 8-10% annually
- Price stability is anticipated due to patent protections and high demand
- Biosimilars unlikely before 2032; potential for price erosion but limited in the near term
Long-Term (Beyond 5 Years)
- Patent expiration around 2032, opening markets for biosimilars
- Potential for price decreases by 20-30%, depending on biosimilar uptake and US market dynamics
- Additional indications and combination therapies could sustain or increase revenue
Sensitivity Factors
- Regulatory delays or restrictions
- New competing therapies or generics
- Reimbursement policy changes
- Innovation in combination treatment paradigms
Summary Table
| Aspect |
Data |
Implication |
| Current Price (Q1 2023) |
~$4,750 per 100 mg vial |
High cost limits off-label use; influences market size |
| Revenue (2022) |
~$8.2 billion |
Mature, growing market with expansion potential |
| Patent expiry |
2032 |
Biosimilar entry expected post-2032 |
| Market growth rate |
8-10% annually |
Steady increase driven by new indications |
Key Takeaways
- Nivolumab (NDC 00591-5543) commands high market share within immune checkpoint inhibitors.
- Pricing has been stable with moderate increases; significant discounts are unlikely before patent expiry.
- Forecasts project steady revenue growth driven by expanding indications.
- Biosimilar competition post-2032 could reduce prices by 20-30%, impacting long-term revenue.
- The drug's global expansion and combination use could offset price declines.
FAQs
1. When is Nivolumab's patent expected to expire?
The primary patent protecting nivolumab is anticipated to expire in 2032, opening opportunities for biosimilar competition.
2. How does nivolumab compare with key competitors?
Nivolumab holds a significant share, but Keytruda has higher global sales due to broader indications and earlier market entry.
3. What are the main drivers of nivolumab's pricing stability?
High demand, patent protections, and lack of biosimilars in the immediate market sustain current prices.
4. How might biosimilars impact the market after 2032?
Biosimilars could reduce prices by 20-30%, lowering overall revenue unless new indications or combination therapies expand usage.
5. What are the main indications for nivolumab currently?
Melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, and several other solid tumors.
References
[1] Bristol-Myers Squibb. (2023). Annual Report 2022.
[2] IQVIA. (2023). Pharmaceutical Market Data.
[3] U.S. Food and Drug Administration. (2014). Nivolumab approval letter.
