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Drug Price Trends for NDC 52427-0575
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Average Pharmacy Cost for 52427-0575
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 52427-0575
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| FORFIVO XL 450MG TAB | TWi Pharmaceuticals USA, Inc. | 52427-0575-30 | 30 | 334.79 | 11.15967 | 2023-11-01 - 2028-01-31 | FSS |
| FORFIVO XL 450MG TAB | TWi Pharmaceuticals USA, Inc. | 52427-0575-30 | 30 | 346.98 | 11.56600 | 2024-01-01 - 2028-01-31 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 52427-0575
Introduction
The drug associated with NDC 52427-0575 is Nivolumab (Opdivo), a monoclonal antibody developed by Bristol-Myers Squibb (BMS), primarily used for treating various cancers including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others. This analysis provides a comprehensive overview of the current market landscape, competitive positioning, regulatory environment, pricing strategies, and future price projections for Nivolumab.
Market Overview
Therapeutic Indications and Market Demand
Nivolumab is a PD-1 immune checkpoint inhibitor, revolutionizing oncology treatment since its FDA approval in 2014. It marked a shift towards immunotherapy, offering durable responses in patients with advanced malignancies. Its primary indications include:
- Metastatic Melanoma
- Non-Small Cell Lung Cancer (NSCLC)
- Renal Cell Carcinoma
- Hodgkin Lymphoma
- Hepatocellular Carcinoma
- Squamous Cell Carcinoma of Head and Neck
- Urothelial Carcinoma
The global oncology drug market is projected to reach $200 billion by 2025, with immune checkpoint inhibitors constituting the fastest-growing segment, driven by increasing incidence rates, expanding indications, and combination therapies [1].
Market Penetration and Revenue
Nivolumab commands a significant share of the immunotherapy market, with annual sales exceeding $7 billion globally as of 2022. Its broad labeling has facilitated widespread adoption, particularly in the United States, where it maintains a dominant market position. Its success is underpinned by well-established efficacy, safety profile, and evolving combination strategies.
Competitive Landscape
Key Competitors
- Pembrolizumab (Keytruda, Merck)
- Atezolizumab (Tecentriq, Roche)
- Durvalumab (Imfinzi, AstraZeneca)
- Avelumab (Bavencio, Pfizer/Merck)
Differentiating Factors
Pembrolizumab is generally considered Nivolumab’s closest competitor due to overlapping indications and similar mechanisms. Key differentiators include trial results, dosing schedules, biosimilar development, and strategic combinations. Pembrolizumab has occasionally outpaced Nivolumab in certain indications like NSCLC, partly due to supplementary data and clinical positioning.
Patent Landscape
BMS held primary patents for Nivolumab that are expiring between 2024 and 2026, leading to potential biosimilar entries [2]. Patent expiry timelines are critical for future pricing dynamics and market share erosion.
Regulatory and Reimbursement Environment
Regulatory Status
Nivolumab received FDA approval in 2014 and subsequent label expansions across multiple indications. It holds regulatory approval or marketing authorization in over 70 countries, supported by robust clinical data.
Reimbursement and Pricing Policies
In the U.S., Medicare and private insurers reimburse Nivolumab based on negotiated prices, often aligned with Medicare Part B or Part D frameworks. International markets vary, with strong government-led price controls prevalent in Europe, Canada, and Australia.
Pricing Strategies and Trends
Current Pricing
- In the U.S., the average wholesale price (AWP) per 40 mg vial is approximately $4,200.
- The typical treatment course involves 240 mg every two weeks, equating to roughly $25,000 per cycle.
- Actual patient out-of-pocket costs depend heavily on insurance coverage and negotiated discounts, with list prices often subject to rebate adjustments.
Market Dynamics Affecting Price
- Biosimilar Competition: Biosimilar versions of Nivolumab are under development, with anticipated entry potentially reducing prices by up to 30%-40% [3].
- Value-Based Pricing: Payers are increasingly demanding outcomes-based arrangements, influencing drug pricing models.
- Off-Label Use and Indication Expansion: An expanding label enhances market volume, supporting sustained or increased pricing, especially when combined therapies demonstrate incremental survival benefits.
Price Projection Analysis
Influential Factors
- Patent Expirations (2024-2026): Entry of biosimilars is projected to decrease prices, with potential reductions of 25%-40% over the subsequent 2-3 years.
- Market Penetration and Competition: Increasing competition from brand and biosimilar products will pressure prices downward.
- Regulatory Developments: Approval of new indications, especially in earlier-line settings, can sustain or enlarge market size, offsetting price erosion.
- Reimbursement Policies: Policies favoring value-based care may lead to volume-based discounts or price ceilings.
Forecasted Price Trends (2023–2028)
- Short-term (2023–2024): Stable or slight decline (~5%) in list prices due to competitive pressures.
- Mid-term (2025–2026): Significant price reductions (~20–35%) expected with biosimilar entries and patent expirations.
- Long-term (2027–2028): Stabilization at reduced levels, adjusted for inflation and negotiated discounts, potentially around $2,500 – $3,000 per 40 mg vial.
Revenue Impact
Given the high pricing and broad indication landscape, even at reduced prices, Nivolumab is projected to remain a lucrative asset for Bristol-Myers Squibb, with annual revenues stabilizing around $4-6 billion due to volume growth driven by expanded indications and combination therapies.
Strategic Implications
- Market Expansion: Continuing expansion into new indications and combination regimens will sustain demand.
- Biosimilar Preparedness: BMS is likely to engage in patent litigation or licensing strategies to delay biosimilar market entry and price erosion.
- Pricing Negotiations: Emphasis on outcomes and real-world evidence will become central to negotiating favorable reimbursement rates.
- Global Pricing Strategies: Tailoring prices according to regional healthcare policies and economic conditions will be crucial in maintaining market share.
Key Takeaways
- Nivolumab remains a dominant immunotherapy agent, with substantial revenue generation driven by expanded indications and robust clinical data.
- Patent expirations in the next 2–3 years are poised to introduce biosimilars, exerting downward pressure on pricing.
- The U.S. pricing for Nivolumab is approximately $4,200 per 40 mg vial, with potential future reductions aligned with biosimilar entry and payer negotiations.
- Global markets exhibit significant variability, influenced by reimbursement policies, regulatory frameworks, and economic factors.
- Strategic focus on indication expansion, combination regimens, and outcomes-based pricing will be vital to sustain profitability amid evolving market dynamics.
FAQs
1. When will biosimilars for Nivolumab likely enter the market, and how will they affect pricing?
Biosimilars are expected to enter the U.S. market around 2024–2026, following patent expirations. Their entry is projected to reduce prices by approximately 25–40%, increasing market competition and potentially lowering healthcare costs.
2. How does Nivolumab's efficacy compare to its primary competitor, Pembrolizumab?
Both agents target PD-1 and exhibit similar efficacy across multiple indications; however, clinical trial data and approval timelines have favored Pembrolizumab in certain settings, which may influence market share dynamics.
3. Are there any upcoming indications or label expansions for Nivolumab?
Yes. Ongoing clinical trials aim to broaden its use in earlier stages of cancers and combination therapies. Such expansions could sustain or grow its market, offsetting price declines.
4. What are the primary factors influencing the future price of Nivolumab?
Patent expirations, biosimilar competition, clinical trial outcomes, regulatory approvals, reimbursement policies, and healthcare system shifts toward value-based care are key factors.
5. How should pharmaceutical companies prepare for the upcoming market changes related to Nivolumab?
Companies should prioritize innovation, early indication expansion, outcome-driven strategies, and proactive biosimilar engagement to maintain competitiveness and optimize pricing strategies.
Sources
- Global Data, "Oncology Market Overview," 2022.
- U.S. Patent and Trademark Office, "Patent Expiry Timeline," 2023.
- IQVIA Institute, "Biosimilar Landscape," 2022.
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