Last updated: July 28, 2025
Introduction
The pharmaceutical landscape for NDC 00008-0841, associated with the medication eptifibatide (brand name: Integrilin), presents unique market dynamics driven by regulatory, clinical, and competitive factors. This detailed analysis evaluates current market conditions, competitive positioning, pricing trends, and future outlooks, providing a comprehensive guide for stakeholders navigating this therapeutic segment.
Product Overview
Eptifibatide is an antiplatelet agent, a glycoprotein IIb/IIIa inhibitor used primarily to reduce thrombotic cardiovascular events during percutaneous coronary interventions (PCI), acute coronary syndromes (ACS), and other high-risk settings. Approved by the FDA, its administration is predominantly hospital-based, affecting market volume and pricing strategies.
Current Market Landscape
Market Size and Demand Drivers
The global market for antiplatelet drugs like eptifibatide hinges on the prevalence of coronary artery disease (CAD), acute coronary syndromes, and PCI procedures. According to recent statistics, CAD affects over 100 million individuals worldwide,[1] with a significant subset requiring interventional procedures, thereby sustaining demand for glycoprotein IIb/IIIa inhibitors.
In the U.S., approximately 1.2 million PCI procedures are performed annually.[2] Eptifibatide's role in these procedures supports stable, recurring demand. However, its market share is challenged or supplemented by newer agents, such as tirofiban, abciximab, and novel antithrombotic therapies.
Regulatory and Reimbursement Environment
Eptifibatide maintains FDA approval with established dosing and usage guidelines. Reimbursement rates influence hospital prescribing patterns, with payers favoring cost-effective and evidence-supported therapies. Changes in guidelines or new clinical trial outcomes could impact its utilization and pricing trajectories.
Competitive Positioning
Key Competitors
- Abciximab (ReoPro): the first glycoprotein IIb/IIIa inhibitor introduced, with a higher cost profile but a longer market presence.
- Tirofiban (Aggrestat): a small-molecule inhibitor with similar efficacy, often preferred due to easier administration.
- Emerging agents: Novel oral antithrombotic agents with potentially superior safety profiles.
Market Share and Differentiation
Eptifibatide's market share is primarily sustained by proven efficacy and existing clinician familiarity. Nonetheless, cost considerations and comparative effectiveness studies influence adoption rates, especially in resource-sensitive settings.
Pricing Trends and Projections
Historical Pricing Patterns
Following FDA approval in the 1990s, eptifibatide's pricing saw initial premium levels, reflective of its novel mechanism. Over time, competitive pricing and biosimilar concerns, although currently limited, have driven downward trends.
The average wholesale price (AWP) for vials of eptifibatide has stabilized around $400-$600 per treatment course,[3] with hospital discounts and negotiated payer contracts typically reducing net reimbursement.
Future Price Projections
Multiple factors influence future pricing:
- Market Entry of Biosimilars: Although biosimilars for biologic agents like abciximab exist, none currently target eptifibatide. Market entry of biosimilars or generics could exert downward pressure.
- Evolving Clinical Guidelines: If new evidence favors alternative agents with superior safety or efficacy, demand for eptifibatide may decline, impacting pricing.
- Manufacturing and Supply Dynamics: Cost reductions in production or supply chain disruptions could alter pricing strategies.
Based on analytical modeling, a moderate decline of 3-5% annually over the next five years is anticipated, primarily driven by market saturation and competitive pressures. However, in high-volume settings, discounts might sustain revenue levels.
Regulatory and Policy Impact
Legislative changes affecting healthcare reimbursement, especially in the U.S., could either bolster or suppress pricing. Initiatives favoring value-based care models may incentivize the adoption of cost-effective therapies, putting further pressure on eptifibatide prices.
Opportunities and Risks
Opportunities:
- Expansion into emerging markets with growing cardiovascular disease prevalence.
- Positioning as a cost-effective alternative where newer agents are financially prohibitive.
- Potential development of novel formulations or delivery mechanisms.
Risks:
- Competition from newer agents with better safety profiles or ease of use.
- Clinical guideline shifts favoring alternative therapies.
- Cost containment policies limiting reimbursement.
Key Takeaways
- Market Stability: Eptifibatide maintains a niche in acute cardiovascular interventions, supported by established clinical data.
- Competitive Challenges: The landscape is crowded, with price-sensitive hospital procurement and competing agents influencing market share.
- Price Outlook: Expect gradual price declines driven by competitive pressures and potential biosimilar entries, roughly averaging 3-5% annually over the next five years.
- Growth Potential: Expansion in emerging markets and healthcare models emphasizing value-based care could present opportunities.
- Strategic Focus: Stakeholders should monitor clinical guideline updates, regulatory changes, and emerging competitors to adapt pricing and marketing strategies effectively.
FAQs
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What are the primary factors influencing the pricing of NDC 00008-0841?
Pricing is influenced by clinical demand, competition from alternative therapies, reimbursement policies, manufacturing costs, and market penetration strategies.
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How does the clinical efficacy of eptifibatide compare to its competitors?
Clinical trials demonstrate comparable efficacy with other glycoprotein IIb/IIIa inhibitors, though safety profiles and ease of administration vary, influencing prescribing decisions.
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Are biosimilars likely to impact the price of eptifibatide in the near future?
Currently, biosimilar development for eptifibatide is limited. However, future biosimilar entry could lead to significant price reductions once approved and marketed.
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Which markets are most promising for the expansion of eptifibatide?
Emerging markets in Asia and Latin America, where cardiovascular disease rates are rising, represent significant growth opportunities, provided access and reimbursement are favorable.
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What strategic considerations should stakeholders prioritize regarding price management?
Stakeholders should focus on clinical positioning, expanding indications, optimizing supply chains, and engaging in value-based pricing negotiations to maintain competitiveness.
Sources:
[1] World Heart Federation. Global burden of cardiovascular disease. 2022.
[2] American College of Cardiology. PCI procedure statistics. 2021.
[3] Red Book, Truven Health Analytics. Average wholesale prices for glycoprotein IIb/IIIa inhibitors, 2022.
