Last updated: February 26, 2026
What Is the Drug Associated with NDC 57237-0233?
NDC 57237-0233 corresponds to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor produced by Bristol-Myers Squibb. It is approved for multiple cancer indications, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others.
Market Overview
Market Size and Demographics
Nivolumab's global market value was approximately $8.4 billion in 2021, with forecasts projecting it to reach around $12 billion by 2027. The key drivers include:
- Increasing cancer incidence rates.
- Expansion of approved indications.
- Growing adoption in combination therapies.
Competitive Landscape
Main competitors include:
- Pembrolizumab (Keytruda, Merck & Co.)
- Atezolizumab (Tecentriq, Genentech)
- Durvalumab (Imfinzi, AstraZeneca)
Pembrolizumab holds the largest market share, estimated at over 50% globally, owing to broader approved indications.
Regulatory and Reimbursement Trends
Regulatory agencies continue to approve new indications. The U.S. FDA has approved Nivolumab for over a dozen cancer types, with ongoing trials expanding its use. Reimbursement policies increasingly favor immunotherapies, especially in oncology centers, supporting revenue growth.
Price Projections
Current Pricing Landscape
Average wholesale prices (AWP) for Nivolumab are approximately:
- Per 240 mg dose: $8,500 to $9,000.
- Per 5 mg/mL vial: About $230.
For the approved doses:
| Indication |
Dose and Frequency |
Annual Cost Estimate |
| Melanoma |
240 mg every 2 weeks |
~$220,000 |
| NSCLC |
240 mg every 2 weeks |
~$220,000 |
| Renal Cell Carcinoma |
480 mg every 4 weeks |
~$180,000 |
Price Trends and Factors
-
Patent Expiry and Biosimilar Entry
Patent protection is scheduled to expire in the US in 2028, possibly leading to biosimilar competition and price erosion.
-
Combination Regimens
Adding Nivolumab to chemotherapy or targeted therapies increases treatment duration and costs, but can elevate the overall value proposition for providers and payers.
-
Reimbursement Policies
Increasing insurance reimbursement favors maintaining current pricing levels, but any policy shifts towards cost containment could pressure prices downward.
-
International Price Variations
Pricing in Europe and Asia varies significantly:
- Europe: Approx. $6,000–$7,000 per dose.
- China: Negotiated lower, around $4,000–$5,000.
Future Price Movement Predictions
- Short-term (1-2 years): Prices are likely to stabilize due to existing patent protections and demand.
- Medium-term (3-5 years): Entry of biosimilars could reduce prices by 20–30% in markets where biosimilars are approved.
- Long-term (5+ years): Prices may decline further, especially in regions with cost-driven healthcare policies.
Key Factors Influencing Price Dynamics
- Patent expiration in the US.
- Development of biosimilars and regulatory approval.
- Market penetration of combination therapies.
- Healthcare reforms and pricing regulations in key markets.
Conclusions
Nivolumab remains a high-value immunotherapy with stable pricing in the near term. Patent expiry, biosimilar competition, and healthcare policy changes are primary sources of future price decline. Strategic market positioning and indication expansion will influence revenue and pricing stability.
Key Takeaways
- Nivolumab (NDC 57237-0233) is a leading immune checkpoint inhibitor with an estimated global market of $8.4 billion (2021), expected to reach $12 billion by 2027.
- Current prices are around $8,500-$9,000 per dose in the US, with regional prices lower.
- Patent expiration in 2028 may introduce biosimilars, reducing prices by 20-30%.
- Reimbursement trends favor immunotherapies, sustaining prices in the near term.
- Price erosion is expected gradually over the next five years, driven by biosimilar competition and healthcare policy shifts.
FAQs
1. When is patent expiration expected for Nivolumab?
Patent protection in the U.S. is slated to expire in 2028, opening the market for biosimilar entrants.
2. How do biosimilars impact the future pricing of Nivolumab?
Biosimilars are projected to reduce prices by 20–30%, depending on regulatory approval and market penetration.
3. What are the main indications for Nivolumab?
It is approved for melanoma, NSCLC, renal cell carcinoma, Hodgkin’s lymphoma, and several other cancers.
4. Are international price differences significant?
Yes, European prices average around $6,000–$7,000 per dose, and Asian prices are often lower due to negotiated discounts.
5. What other factors could influence Nivolumab’s pricing beyond patent expiration?
Emerging combination therapies, healthcare reform, and changes in reimbursement policies can affect pricing strategies.
References
[1] EvaluatePharma. (2022). Global oncology market forecasts.
[2] U.S. FDA. (2022). Nivolumab approved indications summary.
[3] IQVIA. (2022). Worldwide Oncology Trends Report.
[4] European Medicines Agency. (2022). Nivolumab: Pricing and reimbursement information.
[5] MarketWatch. (2023). Oncology drug pricing trends.
