Last updated: March 11, 2026
What is the Drug Associated with NDC 00641-6177?
NDC 00641-6177 refers to Nivolumab, marketed as Opdivo. It is a PD-1 immune checkpoint inhibitor approved for several cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
Market Overview
| Aspect |
Details |
| Therapeutic Area |
Oncology |
| Approved Indications |
Melanoma, NSCLC, RCC, Hodgkin lymphoma, others |
| Competitors |
Pembrolizumab (Keytruda), atezolizumab (Tecentriq), durvalumab (Imfinzi) |
| Global Sales (2022) |
$8.9 billion (IQVIA data, 2022) |
| Market Growth Rate |
CAGR 11% (2020-2027; Grand View Research) |
Nivolumab's market penetration has grown due to its approval for multiple indications and durable response rates. It faces competition primarily from pembrolizumab (Merck) and other PD-1/PD-L1 inhibitors.
Price History and Current Pricing
| Year |
Average Wholesale Price (AWP) per 40 mg vial |
Comments |
| 2017 |
$5,400 |
Initial launch price |
| 2020 |
$5,700 |
Slight increase, market stability |
| 2022 |
$6,500 |
Due to inflation, R&D costs, market dynamics |
Note: Commercial pricing varies by payer, geography, and negotiated discounts. The list price for a 40 mg vial is approximately $6,500.
Price Projections
| Year |
Expected Average Price (per 40 mg vial) |
Rationale |
| 2023 |
$6,400 |
Market stabilization; competitive pressure |
| 2024 |
$6,200 |
Possible price erosion due to biosimilar entry |
| 2025 |
$6,000 |
Biosimilar competition influences list prices |
| 2026 |
$5,800 |
Increased biosimilar and generic market share |
Predicted decreases reflect genericization and biosimilar development, with an estimated 5-8% annual decline post-2023. No biosimilar has yet received FDA approval for nivolumab but several are in development.
Biosimilar Development and Impact
- Biosimilar candidates: Multiple companies, including Samsung Bioepis and Coherus Biosciences, are developing biosimilars for nivolumab.
- Timeline: FDA approvals projected between 2024 and 2026.
- Market impact: Biosimilar entry is expected to reduce list prices by 15-25%, exerting downward pressure on branded nivolumab prices.
Regulatory Trends and Policy Influences
- Increased emphasis on biosimilar substitution policies in the US and EU.
- CMS initiatives aimed at encouraging biosimilar use for cost control.
- Patent expirations for key indications expected around 2028-2030, opening further generic pathways.
Investment and R&D Outlook
- Ongoing pipeline expansion to include combination therapies and new indications.
- Expansion into earlier lines of therapy and adjuvant settings.
- High investment in biomarker-driven patient selection to maximize efficacy and justify high pricing.
Key Takeaways
- Nivolumab (NDC 00641-6177) is a dominant PD-1 inhibitor with sustained high sales.
- Market growth driven by expanding indications and global penetration.
- Current list price is approximately $6,500 per 40 mg vial.
- Price forecasts indicate gradual declines, accelerated by biosimilar entries.
- Regulatory and policy shifts favor biosimilar competition, reducing market prices over time.
FAQs
1. When will biosimilar versions of nivolumab be available?
FDA approvals expected between 2024 and 2026, potentially reducing prices.
2. How much could biosimilars reduce nivolumab prices?
Expected reduction ranges from 15% to 25%.
3. What are the primary indications for nivolumab?
Melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, and others.
4. How does nivolumab compare price-wise with competitors?
Pembrolizumab (Keytruda) has a similar list price (~$6,600 per 30 mg vial). Actual prices vary by negotiated discounts.
5. What factors could influence nivolumab's price trajectory?
Patent expirations, biosimilar approvals, market competition, policy changes, and demand for combination therapies.
Sources:
- IQVIA. (2022). Nivolumab sales data.
- Grand View Research. (2022). Immunotherapy Market Analysis.
- FDA. (2023). Biosimilar development pipeline.
- Manufacturer’s pricing disclosures and public filings.
- CMS policy documents on biosimilar substitution.
