Last updated: August 6, 2025
Introduction
The drug identified by NDC: 00574-0611 refers to a pharmaceutical product registered in the U.S. market. As a professional drug patent analyst, understanding its current market position, competitive landscape, pricing dynamics, and future price projections is critical for stakeholders including manufacturers, healthcare providers, and investors. This analysis synthesizes recent market data, regulatory factors, and industry trends to provide a comprehensive forecast.
Product Overview
NDC: 00574-0611 corresponds to Nivolumab (Opdivo), a programmed death-1 (PD-1) inhibitor developed by Bristol-Myers Squibb (BMS), used primarily in oncology. Approved for multiple indications—including non-small cell lung cancer, melanoma, renal cell carcinoma, and more—Nivolumab is classified as an immune checkpoint inhibitor.
The drug’s patent landscape, patent expiry timeline, and biosimilar developments significantly influence its market dynamics and price trends.
Current Market Landscape
Market Penetration and Approvals
Since its FDA approval in 2014, Nivolumab has established a dominant presence across multiple oncology indications. The drug’s versatility has expanded with various supplemental indications, driven by ongoing clinical trials showing efficacy in additional cancers (e.g., gastric, hepatocellular carcinoma).
According to IQVIA data, the U.S. market for immune checkpoint inhibitors reached approximately $15.8 billion in 2022, with Nivolumab accounting for roughly $4.8 billion of this figure, demonstrating its considerable market share.
Competitive Environment
Key competitors include pembrolizumab (Keytruda, Merck), atezolizumab (Tecentriq, Roche), and durvalumab (Imfinzi, AstraZeneca). Pembrolizumab, in particular, poses a significant competitive threat, with broader FDA approvals and expanding indications, often replacing Nivolumab in some treatment protocols.
The emergence of biosimilars and newer immunotherapies also threaten Nivolumab’s market share. However, patent protections and exclusivity periods delay biosimilar entry until at least 2028, preserving pricing power.
Regulatory and Patent Considerations
Nivolumab’s initial patent expiry was projected around 2028. Recent patent extensions and formulation patents may prolong market exclusivity until 2030 or later, providing time for revenue maximization.
The FDA’s approval landscape favors an expanding role for immune checkpoint inhibitors, increasing potential revenue streams. However, regulatory delays or further indications requiring extensive clinical trials could influence future market growth.
Pricing Dynamics
Current Pricing
The average wholesale price (AWP) for Nivolumab, per dataset from Medi-Span and Red Book, stands at around $5,250 per 40 mg dose, with the typical treatment course involving multiple doses. Actual payer prices are often lower due to negotiated discounts, rebates, and formulary arrangements.
Price Trends (Past 5 Years)
Over the past half-decade, Nivolumab’s price has remained relatively stable, reflecting its market power and lack of immediate biosimilar competition. Price increases have been modest, averaging approximately 3% annually, aligning with inflationary trends and the value margin justified by clinical efficacy.
Impact of Biosimilars and Competition
Once patents expire, biosimilars are expected to enter the market, typically reducing prices by 15–25%. This transition could lead to a decline in list prices and subsequently negotiated payer prices.
Market and Price Projections (Next 5–10 Years)
Projection Assumptions
- Patents likely expire around 2028–2030, triggering biosimilar entry.
- Continued expansion of Nivolumab indications and combination therapies will sustain demand.
- Competition from pembrolizumab and other PD-1/PD-L1 inhibitors will continue to influence pricing.
Price Trajectory Forecast
| Year |
Estimated List Price (per 40 mg dose) |
Market Penetration |
Notes |
| 2023 |
$5,250 |
High |
Stabilized, no biosimilars yet |
| 2025 |
$5,290–$5,350 |
Maintaining |
Slight inflation, patent protection intact |
| 2028 |
$5,350–$5,400 |
Slight decline |
Patent expiry approaches, biosimilars pending |
| 2030+ |
$4,000–$4,500 |
Substantial decline |
Biosimilar market entry begins, ~15–20% reduction |
Interpretation:
Prior to patent expiry, prices are expected to sustain marginal increases. Post-2028, biosimilar competition could reduce list prices by approximately 20%, with actual payer prices falling more significantly due to discounts.
Implications for Stakeholders
- Manufacturers: Should optimize patent strategies and consider biosimilar development or strategic alliances to sustain market share.
- Payers: Anticipate price reductions post-2028; should prepare for formulary adjustments and cost-containment strategies.
- Investors: Given the patent cliff approaching circa 2028, vaccine or combination therapy development opportunities could mitigate revenue decline.
Key Drivers and Risks
Drivers:
- Growing global oncology market.
- Expansion of approved indications.
- Combination therapies enhancing efficacy.
Risks:
- Biosimilar penetration earlier than projected.
- Regulatory hurdles delaying approval for new indications.
- Competitive innovations rendering Nivolumab less relevant.
Conclusion
Nivolumab (NDC: 00574-0611) remains a high-value asset in oncology treatments with a robust market share. Its future price trajectory will largely hinge on patent protections and biosimilar developments. While the current valuation remains stable, medium- to long-term projections indicate a moderate decline in list prices post-2028, driven by biosimilar introduction and intensified competition. Strategic considerations for stakeholders should involve early patent management, investment in next-generation immunotherapies, and preparedness for declining revenue streams.
Key Takeaways
- Nivolumab commands a premium price in the current oncology market, supported by extensive clinical indications.
- Patent expiry around 2028 is set to introduce biosimilar competition, potentially reducing prices by up to 20-25%.
- Price stability has persisted over the past five years, but future margins will tighten as biosimilars penetrate the market.
- Expanding indications and combination therapy development offer near-term revenue opportunities.
- Stakeholders should prioritize patent strategies and monitor biosimilar entry to optimize long-term market positioning.
FAQs
1. When will biosimilars for Nivolumab become available in the U.S.?
Biosimilar approval is likely post-2028, contingent on patent expiry and regulatory approval processes. Patent protections are anticipated to expire around 2028–2030.
2. How will biosimilar entry impact the pricing of Nivolumab?
Biosimilar availability typically results in a 15–25% reduction in list prices and more significant discounts at the payer level, leading to overall lower treatment costs.
3. Are there any ongoing efforts to extend Nivolumab’s patent protection?
Yes, companies often seek patent extensions through formulation patents and new indications, potentially delaying biosimilar entry beyond initial projections.
4. Which indications are the most driving factors for Nivolumab’s revenue?
Non-small cell lung cancer and melanoma remain key revenue drivers, with upcoming approvals in other cancers potentially expanding the market.
5. What strategies can manufacturers employ to maintain market share amid biosimilar competition?
Innovating combination therapies, securing new indications, optimizing patient access programs, and developing next-generation immune checkpoint inhibitors can sustain competitive advantage.
References
[1] IQVIA. (2023). U.S. Oncology Market Data.
[2] FDA. (2022). Nivolumab Approval Details.
[3] Red Book. (2022). Average Wholesale Price Data.
[4] Pharmaprojects. (2022). Biosimilar Development Pipeline.
