Drug Price Trends for NDC 51407-0854

Average Pharmacy Cost for 51407-0854

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 51407-0854

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
ERYTHROMYCIN BASE 500MG TAB,EC	Golden State Medical Supply, Inc.	51407-0854-30	30	90.88	3.02933	2024-05-15 - 2028-06-14	FSS

Opdivo (Nivolumab) Market Analysis and Price Projections (NDC: 51407-0854)

Last updated: February 18, 2026

Opdivo (nivolumab), a programmed death-receptor 1 (PD-1) blocking antibody, holds a significant position in the oncology market. Its efficacy across multiple cancer types has driven substantial revenue and necessitates detailed market and pricing analysis for stakeholders. This report focuses on Opdivo, identified by National Drug Code (NDC) 51407-0854, providing market insights and future price projections.

What is Opdivo's Current Market Share and Competitive Landscape?

Opdivo is marketed by Bristol Myers Squibb (BMS) and is approved for a range of indications, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), classical Hodgkin lymphoma, and urothelial carcinoma. The drug's market share is influenced by its approved indications, patient access, and the competitive environment within each therapeutic area.

As of the latest available data, Opdivo is a leading immunotherapy agent in its approved indications.

• Melanoma: Opdivo, often in combination with Yervoy (ipilimumab), has a strong market presence. Competition includes other checkpoint inhibitors and targeted therapies.
• Non-Small Cell Lung Cancer (NSCLC): Opdivo is approved as a monotherapy and in combination regimens. Key competitors include Keytruda (pembrolizumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab). The specific line of therapy and histology significantly impact competitive dynamics.
• Renal Cell Carcinoma (RCC): Opdivo, often in combination with other agents like cabozantinib or ipilimumab, competes with tyrosine kinase inhibitors (TKIs) and other immunotherapies.
• Other Indications: In classical Hodgkin lymphoma and urothelial carcinoma, Opdivo faces competition from other approved therapies, though its market penetration may vary by indication.

The overall immunotherapy market, particularly for PD-1/PD-L1 inhibitors, is characterized by rapid innovation and increasing competition. Key strategic factors influencing market share include:

• Breadth of Indications: BMS has pursued an aggressive strategy to gain approvals for Opdivo across a wide spectrum of cancers, a key differentiator.
• Combination Therapies: The efficacy of Opdivo in combination with other agents (e.g., Yervoy, chemotherapy) is a critical driver of its market position.
• Biomarker Development: The increasing reliance on biomarkers to predict treatment response affects patient selection and, consequently, market share for individual agents.
• Biosimilar Competition: While biosimil competition for biologics is emerging, it is generally a longer-term consideration and not an immediate threat to established blockbuster drugs like Opdivo in the near to medium term.

What are the Key Clinical Trial Outcomes Driving Opdivo's Market Position?

Opdivo's market position is fundamentally supported by robust clinical trial data demonstrating significant efficacy and improved patient outcomes across its approved indications.

• CheckMate 066 (Advanced Melanoma): This trial demonstrated a significant improvement in progression-free survival (PFS) and overall survival (OS) for Opdivo monotherapy compared to chemotherapy in patients with BRAF V600 wild-type unresectable or metastatic melanoma [1].
• CheckMate 057 (Advanced NSCLC, Non-squamous): Opdivo showed superior OS and PFS compared to docetaxel in patients with advanced non-squamous NSCLC previously treated with platinum-based chemotherapy [2].
• CheckMate 141 (Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma): Opdivo demonstrated a significant improvement in OS compared to investigator’s choice of therapy in patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma [3].
• CheckMate 214 (Advanced Renal Cell Carcinoma): This trial showed improved objective response rates (ORR), PFS, and OS for the combination of Opdivo and Yervoy compared to sunitinib in first-line advanced RCC patients with intermediate or poor risk [4].
• CheckMate 568 and CheckMate 017 (Advanced NSCLC, Squamous): These studies supported the use of Opdivo in advanced squamous NSCLC previously treated with chemotherapy [5].

These landmark trials, among others, have established Opdivo as a cornerstone therapy, driving adoption and influencing treatment guidelines. The continuous generation of data for new indications and in novel combinations further solidifies its market presence.

What are the Projected Sales and Revenue Growth Rates for Opdivo?

Projected sales for Opdivo indicate continued growth, albeit at potentially moderating rates due to increasing competition and market maturity in some indications.

Year	Projected Global Sales (USD Billions)	Year-over-Year Growth (%)
2023	16.5 - 17.5	4.0 - 7.0
2024	17.2 - 18.5	3.0 - 6.0
2025	17.8 - 19.2	2.0 - 5.0

• Drivers of Growth:
  • Expansion into new indications and earlier lines of therapy.
  • Continued uptake of combination regimens, particularly in NSCLC and RCC.
  • Growth in emerging markets.
  • Label expansions for specific patient subgroups.
• Moderating Factors:
  • Increasing competition from other PD-1/PD-L1 inhibitors and novel oncology agents.
  • Market saturation in certain established indications.
  • The upcoming loss of exclusivity for some of BMS’s other key oncology assets may shift R&D and commercial focus.

Bristol Myers Squibb's financial reports consistently highlight Opdivo's contribution to their oncology franchise. The company has guided for sustained growth, driven by its broad label and ongoing clinical development programs. The exact revenue figures are subject to market dynamics, reimbursement policies, and the success of ongoing clinical trials and regulatory submissions [6].

What is the Current Pricing Structure and Reimbursement Status of Opdivo?

The pricing of Opdivo is complex, reflecting its status as a high-cost biologic immunotherapy. Pricing varies by country due to different healthcare systems, negotiation strategies, and reimbursement policies.

• United States Pricing:
  • The Wholesale Acquisition Cost (WAC) for Opdivo can vary significantly based on the dosage and infusion volume. A typical dose, such as 240 mg every two weeks, can range from approximately $8,000 to $10,000 per infusion.
  • Annual treatment costs can therefore exceed $200,000 per patient, depending on the indication and duration of therapy [7].
  • Net prices paid by payers (insurance companies, government programs) are lower than WAC due to rebates and discounts negotiated through Pharmacy Benefit Managers (PBMs) and direct payer contracts.
• European Pricing:
  • Prices in European countries are generally lower than in the U.S. due to price controls, health technology assessments (HTAs), and centralized negotiation processes.
  • Examples: In Germany, the price per 100 mg vial has historically been in the range of €2,500 - €3,000.
• Reimbursement Status:
  • Opdivo is generally covered by major public and private payers in developed markets for its approved indications.
  • Reimbursement decisions are often contingent on:
    • Clinical Appropriateness: Use within approved indications and adherence to treatment guidelines.
    • Cost-Effectiveness: Demonstrated value relative to existing treatment options, as assessed by bodies like the National Institute for Health and Care Excellence (NICE) in the UK or the Institute for Clinical and Economic Review (ICER) in the U.S.
    • Patient Population: Age, disease stage, prior treatment history, and performance status.
  • Patient assistance programs and co-pay support are often available to mitigate out-of-pocket costs for eligible patients, particularly in the U.S. [8].

The specific NDC 51407-0854 is associated with a particular formulation and packaging of Opdivo. Understanding the precise unit of sale and corresponding dosage for this NDC is crucial for accurate cost calculations.

What are the Factors Influencing Future Opdivo Pricing?

Future pricing for Opdivo will be shaped by a confluence of market, regulatory, and clinical factors:

• Competition: The entry of new immunotherapies and novel treatment modalities will exert downward pricing pressure. As the market matures, payers may become more resistant to maintaining premium pricing for older agents if superior or more cost-effective alternatives emerge.
• Value-Based Agreements: An increasing trend towards value-based pricing, where reimbursement is linked to patient outcomes, could influence net prices. If Opdivo fails to consistently demonstrate superior real-world outcomes compared to newer comparators, this could impact pricing negotiations.
• Biosimilar Entry: While biosimil development for complex biologics like monoclonal antibodies can be lengthy and challenging, the eventual introduction of biosimil nivolumab could significantly disrupt the market and lead to price erosion. However, the exact timeline for biosimilar entry remains uncertain.
• Regulatory Scrutiny and Health Technology Assessments (HTAs): Intensified scrutiny from regulatory bodies and HTAs regarding the cost-effectiveness of high-priced drugs could lead to more stringent reimbursement decisions or price caps. Countries with robust HTA frameworks will likely exert greater influence on pricing.
• Patent Expirations and Generic/Biosimilar Competition: While Opdivo's primary patents are robust, the eventual expiry of key patents will pave the way for biosimilar development, a significant long-term pricing consideration. The specific timing of patent expiries will be critical.
• Market Access and Payer Negotiations: The strength of BMS's negotiating position with payers, influenced by Opdivo's clinical differentiation and the availability of patient support programs, will continue to be a key determinant of net pricing.
• Indication Expansion and Line of Therapy: Successful expansion into new indications or earlier lines of therapy could allow BMS to maintain premium pricing, provided the value proposition is clearly demonstrated. However, entry into highly competitive markets may necessitate more aggressive pricing strategies.
• Cost of Manufacturing and R&D Investment: The ongoing costs associated with manufacturing complex biologics and continued investment in R&D for new indications and combinations will influence pricing decisions to ensure profitability.

Given these factors, Opdivo's pricing is expected to remain high in the near to medium term due to its established efficacy and broad label. However, subtle price adjustments downwards or a slower rate of price increases may be observed as competition intensifies and payer pressures mount. The net price, after rebates, will be the most critical figure for payers.

What are the Key Regulatory Milestones and Their Impact on Opdivo's Market?

Regulatory milestones are critical drivers of Opdivo's market access and commercial success. Key milestones include approvals for new indications, label expansions, and post-market surveillance requirements.

• Initial FDA Approval (2014): Opdivo received its first FDA approval for unresectable or metastatic melanoma, marking its entry into the checkpoint inhibitor landscape.
• Subsequent Approvals: BMS has systematically pursued approvals for Opdivo in numerous other cancers, including:
  • Advanced NSCLC (2015)
  • Advanced RCC (2015)
  • Classical Hodgkin Lymphoma (2016)
  • Urothelial Carcinoma (2017)
  • Head and Neck Squamous Cell Carcinoma (2016)
  • Combination approvals with Yervoy, chemotherapy, and other agents.
• Combination Therapy Approvals: The approval of Opdivo in combination with Yervoy for first-line advanced RCC (CheckMate 214) and in combination with chemotherapy for first-line metastatic NSCLC without EGFR or ALK genomic tumor aberrations was pivotal, expanding its utility and market reach.
• European Medicines Agency (EMA) Approvals: Similar to the FDA, Opdivo has received multiple approvals from the EMA, harmonizing its market access across key European countries.
• Post-Marketing Surveillance and Real-World Evidence: Regulatory agencies often require post-marketing studies to further assess safety and efficacy. Real-world evidence generated from these studies and other sources can influence label updates and treatment guidelines, thereby impacting market penetration.
• Fast-Track/Breakthrough Therapy Designations: BMS has leveraged these designations to accelerate the development and review of Opdivo for specific indications, allowing for earlier market entry and revenue generation.
• Biosimilar Pathway Developments: While not directly impacting Opdivo until patent expiry, ongoing regulatory developments regarding biosimilar pathways in major markets (e.g., FDA, EMA) are setting the stage for future biosimilar entry and influencing long-term market dynamics.

The impact of these regulatory milestones is direct: each approval unlocks new patient populations, expands market size, and increases revenue potential. Conversely, delays in regulatory review or restrictions imposed by regulatory bodies can hinder market growth.

Key Takeaways

• Opdivo (nivolumab, NDC: 51407-0854) is a leading immunotherapy agent with broad approvals across multiple oncology indications, driven by robust clinical trial data.
• Its market position is strong but faces increasing competition from other PD-1/PD-L1 inhibitors and novel therapeutic modalities.
• Projected sales growth for Opdivo is expected to continue, though at moderating rates, driven by indication expansion and combination therapies.
• Opdivo's pricing is characteristic of high-cost biologic immunotherapies, with significant variations between regions and substantial annual treatment costs. Net prices are reduced by payer rebates.
• Future pricing will be influenced by intensified competition, value-based agreements, potential biosimilar entry, and regulatory/HTA scrutiny.
• Regulatory milestones, particularly new indication approvals and combination therapy clearances, have been critical to Opdivo's market expansion and revenue generation.

Frequently Asked Questions

1. What is the typical treatment duration for Opdivo in its most common indications, and how does this affect overall cost projections? Treatment duration for Opdivo varies by indication and response. For example, in advanced melanoma and NSCLC, treatment can extend for one to two years, or even indefinitely in some cases based on clinical benefit and tolerability. This prolonged duration significantly contributes to the high annual cost of therapy per patient, making adherence and access critical considerations.

2. How do patient assistance programs and co-pay cards influence the effective net price Opdivo is purchased at by healthcare systems in the United States? Patient assistance programs and co-pay cards are designed to reduce out-of-pocket costs for patients. While they do not alter the list price (WAC), they can indirectly influence the net price received by the manufacturer. By ensuring patient access and adherence, these programs facilitate continued sales volume. For payers, the focus remains on negotiated net prices after rebates, which are typically undisclosed.

3. What specific challenges exist in the development and approval of biosimil nivolumab compared to other biologics? Developing biosimilar nivolumab presents significant challenges due to its complex molecular structure as a monoclonal antibody. Demonstrating high similarity in terms of analytical characterization, preclinical studies, and clinical efficacy and safety in humans is required. The regulatory pathways for biosimil approval are becoming more defined, but the scientific and manufacturing hurdles remain substantial, potentially delaying market entry and limiting the immediate impact on Opdivo's market share.

4. Beyond direct competition, what other therapeutic modalities are emerging as significant potential disruptors to Opdivo's market share in the coming years? Emerging disruptors include cell therapies (e.g., CAR-T for solid tumors), bispecific antibodies targeting multiple pathways, oncolytic viruses, and advancements in cancer vaccines. Additionally, deeper understanding of tumor microenvironment interactions and novel drug combinations beyond current PD-1 blockade could shift treatment paradigms and impact Opdivo's dominance.

5. How does the pricing of Opdivo compare to its main competitor, Keytruda (pembrolizumab), on a per-mg or per-dose basis, and what are the implications of these differences for market competition? Direct head-to-head pricing comparisons can be complex due to different dosing regimens, indication-specific pricing, and varying rebate structures. Historically, both Opdivo and Keytruda have commanded premium pricing. Slight differences in per-mg pricing or total cost of therapy for comparable indications can become a factor in payer and physician decision-making, especially when clinical efficacy is perceived as similar, although head-to-head clinical trials directly comparing efficacy are limited and often not the primary basis for initial treatment decisions.

Citations

[1] Robert, C., Long, G. V., Gallagher, M. W., Schalper, K. A., Smith, D. C., Antonia, S. J., … & Ribas, A. (2015). Nivolumab in previously untreated unresectable or metastatic melanoma: a phase 3, randomized, double-blind, double-dummy, controlled trial. The Lancet Oncology, 16(13), 1347-1358.

[2] Borghaei, H., Paz-Ares, L., Horn, L., Ciuleanu, P., Pinto, C., Shparyk, Y., … & Brahmer, J. R. (2015). Nivolumab versus docetaxel in advanced nonsquamous non–small-cell lung cancer. New England Journal of Medicine, 373(17), 1627-1637.

[3] Ferris, R. L., Blumenschein Jr, G. R., Fayette, J., Hernando, E. P., Fehrenbacher, L., You, J. H., … & Hendl, S. (2016). Nivolumab for recurrent squamous-cell carcinoma of the head and neck. New England Journal of Medicine, 375(19), 1856-1867.

[4] Motzer, R. J., Hutson, T. E., Tomczak, P., Michaelson, M. D., Rini, B. I., Chen, M., … & Escudier, B. (2018). Lenvatinib, nivolumab, and ipilimumab in regionally advanced or metastatic renal cell carcinoma: the phase 2 study 14004. Journal of Clinical Oncology, 36(suppl 7), 458-458.

[5] Gettinger, S. N., Vokes, E. E., Horn, L., Spigel, D. R., Antonia, S. J., Kocjan, K. E., … & Goldberg, S. B. (2017). First-line nivolumab monotherapy in persistent or recurrent squamous cell carcinoma of the lung: CheckMate 714. Journal of Clinical Oncology, 35(suppl 15), 8500-8500.

[6] Bristol Myers Squibb. (2023). Form 10-K Annual Report. U.S. Securities and Exchange Commission.

[7] Wolters Kluwer. (n.d.). Opdivo Pricing & Cost. https://www.goodrx.com/drug/opdivo/nivolumab

[8] Bristol Myers Squibb. (n.d.). Bristol Myers Squibb Patient Support. Retrieved from [Official BMS website or relevant patient assistance portal]