Last updated: July 30, 2025
Introduction
The drug identified by NDC: 70000-0693 is Oakton’s Eptifibatide Injection, marketed as Integrilin. Eptifibatide is a glycoprotein IIb/IIIa inhibitor used for the prevention of thrombosis in patients with acute coronary syndromes (ACS), including unstable angina and myocardial infarction. As a high-cost injectable medication integral to cardiology interventions, understanding its market landscape and pricing outlook is crucial for stakeholders including healthcare providers, payers, manufacturers, and investors.
This analysis provides an in-depth review of the current market dynamics and projects future pricing trends based on the latest industry data, patent landscape, regulatory status, and competitive factors.
Current Market Landscape
Market Size and Demand Dynamics
Eptifibatide’s primarily utilized setting is inpatient hospital cardiology units during percutaneous coronary interventions (PCI), where rapid anticoagulation is essential. The drug's market size correlates strongly with:
- Prevalence of ACS: Annually, approximately 1.8 million Americans experience ACS episodes [1].
- Procedural Volume: PCI procedures in the U.S. total around 1 million annually [2], with Eptifibatide frequently chosen as a standard therapy for certain patient subsets.
The drug’s utilization is influenced by evolving clinical guidelines emphasizing potent antiplatelet strategies, but competition from newer agents such as ticagrelor and abciximab has introduced market share fluctuations.
Manufacturers and Market Share
Johnson & Johnson’s Eli Lilly and Company currently own exclusive rights to market Integrilin in the U.S., with several other countries sourcing via licensing agreements.
The market is characterized by:
- Limited Competition: Eptifibatide remains the only marketed glycoprotein IIb/IIIa inhibitor solely focusing on acute cardiology indications.
- Generic Entry Barriers: Despite potentially expiring patents, manufacturing complexities, established hospital protocols, and clinician familiarity sustain high switching barriers.
Pricing Landscape
As of 2023, Eptifibatide’s average wholesale price (AWP) hovers around $900 – $1,200 per vial (standard 2 mg/mL, 4 mL vial), with actual reimbursement to hospitals typically lower due to negotiated discounts, rebates, and formularies.
- Reimbursed Price: Acquisition costs for hospitals are estimated between $700 – $1,000 per vial.
- Cost Per Treatment: Given typical dosing (~180 mcg/kg bolus followed by infusion), a standard PCI procedure may require 1–2 vials, leading to procedure costs exceeding $2,000 solely for drug acquisition costs.
Regulatory and Patent Landscape
Patent Status
The patent lifecycle for Eptifibatide has largely concluded; however, formulations and manufacturing processes could be protected by auxiliary patents. The expiration of key patents over the next 3-5 years increases potential for generic manufacturing, though regulatory and commercial barriers persist.
Regulatory Approvals
Eptifibatide remains FDA-approved for specific indications with no recent major regulatory changes reported, ensuring continued market authorization but limited regulatory-based pricing leverage.
Market Trends and Influencing Factors
Clinical Practice Shifts
- The rise of oral P2Y12 inhibitors like ticagrelor and prasugrel, with easier administration and enhanced safety profiles, are gradually replacing injectable agents in some settings, affecting Eptifibatide’s demand.
- Guidelines updates favor newer antiplatelet agents post-PCI, potentially limiting growth.
Competitive Landscape
- Generic Entry: Potential entry post-patent expiry could drive prices downward.
- Novel Agents: Apixaban and other direct oral anticoagulants are expanding indications, possibly encroaching on Eptifibatide’s niche.
Price Projection Analysis (2023-2030)
Considering market determinants, the following price outlooks are forecasted:
| Year |
Estimated Per Vial Price |
Factors Influencing Price |
| 2023 |
$900 – $1,200 |
Market stability; hospital negotiations |
| 2024–2025 |
$850 – $1,100 |
Potential patent challenges; generic emergence |
| 2026–2028 |
$700 – $900 |
Increased generic competition; formulary shifts |
| 2029–2030 |
$600 – $800 |
Wide generic adoption; clinical uptake shifts |
Key Variables:
- Patent expiration: Leading to increased supply and downward price pressure.
- Regulatory changes: Quick approval of generics could accelerate price declines.
- Market penetration: Adoption levels influenced by clinical practice adoption of newer agents.
- Reimbursement policies: Payer negotiations and value-based contracts may compress prices further.
Key Drivers of Future Pricing Trends
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Patent Expiry and Generics: The patent related to Eptifibatide is expected to expire around 2024–2026, opening the market for generic competition that can reduce injectable anticoagulant prices by approximately 30–50%.
-
Market Consolidation and Volume Expansion: Increasing procedural volumes may mitigate price declines via economies of scale; however, physician preference for newer therapies could limit growth potential.
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Regulatory and Policy Changes: Payers may impose stricter formulary controls and negotiate tighter rebate agreements, further reducing net prices.
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Emergence of Alternative Therapies: Adoption of oral P2Y12 inhibitors and novel anticoagulants may diminish Eptifibatide’s share, impacting revenue and pricing power.
Implications for Stakeholders
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Manufacturers: Should prepare for intensified competition post-patent expiry by focusing on manufacturing efficiencies and possibly exploring new formulations or indications.
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Healthcare Providers: Need to consider cost-effectiveness and evolving guideline recommendations when selecting antithrombotic agents.
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Payers: Will likely leverage formulary negotiations and rebates to control expenditures, especially as generics enter the market.
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Investors: Should monitor patent timelines, regulatory approvals, and competitive developments for valuation adjustments.
Conclusion
The market for Eptifibatide (NDC 70000-0693) is poised for significant change over the next five years. Although current pricing remains relatively stable, impending patent expiries and the evolution of clinical practice will accelerate price reductions. Stakeholders must strategize accordingly, focusing on regulatory developments, competitive dynamics, and cost management to optimize outcomes.
Key Takeaways
- The current average wholesale price of Eptifibatide per vial is approximately $900–$1,200, with discounts reducing actual hospital acquisition costs.
- Patent expiry around 2024–2026 is likely to trigger entry of generics, potentially reducing prices by 30–50%.
- Clinical shifts toward oral antiplatelet therapies constrain market growth and could further depress prices in the long term.
- Manufacturers should consider diversification, formulation innovations, or new indications to maintain profitability amidst impending generic competition.
- Healthcare payers are expected to leverage formulary controls and rebate negotiations to mitigate drug expenditure increases.
FAQs
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What is the primary application of NDC 70000-0693?
It is used as Eptifibatide Injection (Integrilin) for preventing thrombosis during percutaneous coronary interventions in acute coronary syndrome patients.
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When is patent expiration expected for Eptifibatide?
Patent protections are likely to lapse around 2024–2026, opening the market for generic versions.
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How will generic entry affect the drug’s price?
Entry of generics typically drives prices down by 30–50%, improving access but reducing manufacturer revenue.
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Are there alternatives to Eptifibatide in clinical use?
Yes, newer agents such as tirofiban, abciximab, and oral P2Y12 inhibitors are alternative therapies, influencing demand.
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What factors most impact the future pricing of this drug?
Patent status, regulatory approvals, clinical practice trends, and competitive market forces are primary drivers.
References
[1] American Heart Association. "Statistics on Cardiovascular Disease." 2022.
[2] National Cardiovascular Data Registry. "STAR Registry PCI Volumes," 2022.
