Last updated: February 21, 2026
What is the Drug Associated With NDC 00597-0425?
NDC 00597-0425 corresponds to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor indicated primarily for the treatment of various cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, Hodgkin lymphoma, and others.
Market Landscape
Key Indications and Market Size
- Melanoma: Nivolumab is approved for metastatic and adjuvant melanoma.
- NSCLC: First-line and subsequent therapies.
- Renal Cell Carcinoma: Approved for advanced cases.
- Hodgkin Lymphoma: Relapsed/refractory cases.
In 2022, the global oncology checkpoint inhibitors market was valued at approximately $15.2 billion, with Nivolumab representing roughly 45-50% of that, reflecting its leading market share.
Competitive Environment
Major competitors include:
- Pembrolizumab (Keytruda) from Merck
- Atezolizumab (Tecentriq) from Roche
- Cemiplimab (Libtayo) from Regeneron/Sanofi
Market share in PD-1/PD-L1 inhibitors for oncology approximated 55% for Nivolumab in 2022, driven by established approvals, combination regimens, and broad therapeutic coverage.
Therapeutic Approvals and Indications Timeline
| Year |
Approval |
Indication |
Notes |
| 2014 |
FDA |
Melanoma |
First PD-1 approval |
| 2016 |
FDA |
NSCLC, Renal cell carcinoma |
Expanded uses |
| 2017 |
FDA |
Hodgkin lymphoma |
Fourth major indication |
| 2021 |
FDA |
Adjuvant melanoma |
Topical expansion |
Revenue Impact
- In 2022, Bristol-Myers Squibb (BMS) reported $4.8 billion in nivolumab sales worldwide.
- Approximate United States market share: 70%.
- Growth driven by ongoing approvals in additional indications and combination therapies.
Price Projection Analysis
Current Pricing
- Average Wholesale Price (AWP): Approximately $5,600 per 100 mg dose (varies by manufacturer and payer discounts).
- Monthly treatment (assuming 240 mg dose every 2 weeks):
- 480 mg per month (biweekly dosing), costing ~$26,880 (before discounts).
- Average price per patient per year: $300,000 to $350,000, based on dosage and treatment duration.
Market Trends and Future Pricing
- Patent extension and exclusivity: Patent protection extends until 2031, with potential pipeline exclusivity until 2034.
- Biosimilar entry: Expected around 2031-2033, which could reduce prices by 20-40%.
- Pricing pressure factors:
- New competition from biosimilars.
- Payer negotiation leverage.
- Value-based pricing models linked to outcomes.
Price Trajectories
| Timeframe |
Expected Price Change |
Notes |
| 2023-2025 |
Stable to slight decrease |
Due to payer negotiations and usage expansions. |
| 2026-2030 |
Potential 10-20% decline |
Biosimilar market entry pressure increases. |
| Post-2031 |
30-50% reduction possible |
Biosimilar competition becomes significant. |
Revenue Projections (2023-2028)
| Year |
Estimated global sales |
Key Drivers |
| 2023 |
$4.9 billion |
Full year impact of expanded indications and lines. |
| 2024 |
$5.2 billion |
Increased use in adjuvant settings and combination therapies. |
| 2025 |
$5.5 billion |
Continued indication expansion and increased adoption. |
| 2026 |
$5.8 billion |
Biosimilar entry begins, potentially reducing price. |
| 2027 |
$5.0 billion |
Biosimilar competition impacts sales. |
| 2028 |
$4.5 billion |
Ongoing biosimilar market penetration and price reductions. |
Regulatory Considerations
- Ongoing trials aim for expanded indications including earlier-stage cancers and novel immune combinations.
- Patent and exclusivity strategies influence pricing and market longevity.
Key Takeaways
- Nivolumab remains a leading immune checkpoint inhibitor with significant market share.
- Pricing is currently high, averaging $300,000-$350,000 annually per patient.
- Market growth is driven by new indications, combination therapies, and expanding patient access.
- Biosimilar competition expected post-2031 could substantially lower prices.
- Overall revenue is projected to grow slightly until biosimilar entry, after which the market will face shrinkage and price reductions.
FAQs
Q1: When are biosimilars for Nivolumab expected?
A1: Biosimilars are projected to enter the market around 2031-2033, following patent expiry and regulatory approval processes.
Q2: How much could prices decrease with biosimilar competition?
A2: Prices may decline by 30-50%, depending on market dynamics and regulatory approvals.
Q3: What are the primary indications currently driving revenues?
A3: Melanoma, NSCLC, renal cell carcinoma, and Hodgkin lymphoma.
Q4: How do payer negotiations impact the drug's price?
A4: Negotiations can reduce wholesale prices by 10-20%, depending on volume, indication, and payer policies.
Q5: What is the potential for price increases due to new indications?
A5: Introduction of new approved indications and combination therapies can sustain or slightly raise current pricing in the short term.
References
- Bristol-Myers Squibb. (2022). Opdivo (Nivolumab) sales reports.
- IQVIA. (2022). Global oncology market analysis.
- FDA. (2014-2022). Approvals and indications for Nivolumab.
- EvaluatePharma. (2022). Oncology drugs market forecast.
- GLOBOCAN, International Agency for Research on Cancer. (2022). Cancer statistics.
