EPTIFIBATIDE - Generic Drug Details

What are the generic sources for eptifibatide and what is the scope of freedom to operate?

Eptifibatide is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hybio, Meitheal, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Slate Run Pharma, Teva Pharms Usa, USV, and Msd Sub Merck, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for eptifibatide. Eight suppliers are listed for this compound.

Summary for EPTIFIBATIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	16
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	37
Patent Applications:	6,313
Drug Prices:	Drug price trends for EPTIFIBATIDE
What excipients (inactive ingredients) are in EPTIFIBATIDE?	EPTIFIBATIDE excipients list
DailyMed Link:	EPTIFIBATIDE at DailyMed

See drug prices for EPTIFIBATIDE

Recent Clinical Trials for EPTIFIBATIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zhujiang Hospital	PHASE2
Baylor College of Medicine	Phase 1/Phase 2
Assiut University	Phase 1/Phase 2

See all EPTIFIBATIDE clinical trials

Pharmacology for EPTIFIBATIDE

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for EPTIFIBATIDE

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for EPTIFIBATIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTEGRILIN	Injection	eptifibatide	2 mg/mL, 100 mL vial	020718	1	2008-12-18
INTEGRILIN	Injection	eptifibatide	2 mg/mL, 10 mL vial	020718	1	2008-09-30

US Patents and Regulatory Information for EPTIFIBATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	208554-002	Nov 23, 2018	AP	RX	No	No
Teva Pharms Usa	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	090854-001	Jun 12, 2015	AP	RX	No	No
Accord Hlthcare	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	205557-002	Nov 6, 2017		DISCN	No	No
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998		DISCN	Yes	No

Expired US Patents for EPTIFIBATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998	5,747,447
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998	5,686,570
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998	5,756,451
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998	5,807,825

EU/EMA Drug Approvals for EPTIFIBATIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Eptifibatide Accord	eptifibatide	EMEA/H/C/004104Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin.Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).	Authorised	yes	no	no	2016-01-11
GlaxoSmithKline (Ireland) Limited	Integrilin	eptifibatide	EMEA/H/C/000230Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin.Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes.Patients most likely to benefit from Integrilin treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous transluminal coronary angioplasty (PTCA).	Authorised	no	no	no	1999-07-01

Market Dynamics and Financial Trajectory for Eptifibatide

Last updated: July 28, 2025

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Introduction

Eptifibatide stands as a pivotal antiplatelet agent within the pharmaceutical landscape, primarily indicated for acute coronary syndromes (ACS) and percutaneous coronary interventions (PCI). As a synthetic cyclic peptide mimicking the RGD sequence, it inhibits glycoprotein IIb/IIIa receptors, effectively reducing thrombotic events. Analyzing its market dynamics and financial trajectory provides insights into its current standing and future prospects amidst evolving cardiovascular treatment paradigms.

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Market Overview and Therapeutic Context

The global cardiovascular disease (CVD) market continues to expand, driven by aging populations, sedentary lifestyles, and rising prevalence of risk factors such as hypertension, diabetes, and hyperlipidemia. Anti-platelet therapies like eptifibatide occupy a critical niche, especially in acute settings requiring rapid platelet inhibition.

Eptifibatide, marketed under Integrilin by Merck & Co., faces competition from other glycoprotein IIb/IIIa inhibitors such as abciximab and tirofiban. Despite these competitors, eptifibatide retains a significant share in indications like PCI, particularly in the U.S. and select European regions, due to its efficacy and safety profile derived from extensive clinical trials.

The market is influenced by shifting guidelines favoring oral antiplatelets for secondary prevention and the advent of novel antithrombotic agents, emphasizing the importance of understanding eptifibatide's positioning amidst these trends.

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Market Dynamics Influencing Eptifibatide

1. Therapeutic Guidelines and Clinical Evidence

Efficacy data from landmark trials such as the ESPRIT (Eptifibatide in the Treatment of Patients with Unstable Angina/Non-Q Wave Myocardial Infarction) have cemented its role in PCI procedures. However, evolving guidelines increasingly recommend oral agents like ticagrelor and prasugrel, which may limit the use of short-acting intravenous agents to specific high-risk or procedural settings.

2. Regulatory Environment and Patent Expiry

Eptifibatide's original patent protection has historically contributed to market exclusivity. However, patent expirations, coupled with biosimilar threats, implications for pricing and profitability are areas of concern. The patent landscape varies across geographies, with the U.S. patents potentially expiring soon, opening the market to generic or biosimilar entrants.

3. Competitive Landscape

Generic versions and newer oral antiplatelets challenge the market share of eptifibatide. Moreover, advancements in antithrombotic therapy, including direct oral anticoagulants (DOACs) and novel inhibitors, influence prescribing patterns. Market players are also exploring targeted delivery systems and combination therapies to maintain relevance.

4. Healthcare Infrastructure and Reimbursement

Reimbursement policies significantly impact eptifibatide’s utilization. Hospitals prioritize cost-effective interventions, especially amid rising healthcare costs. Cost-benefit analyses that highlight the drug’s efficacy in preventing adverse events are crucial for maintaining market share.

5. Innovation and New Formulations

Recent research into extended-release formulations and combination products could influence future demand. Additionally, the integration of eptifibatide into multi-agent protocols for acute coronary interventions remains a strategic factor shaping its trajectory.

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Financial Trajectory and Market Performance

Revenue Trends

Historically, eptifibatide’s annual revenues reflected its pivotal role in PCI, with peak sales during the early 2010s. Post patent expiration and competition led to a decline in revenue growth, with some markets witnessing significant erosion of sales volumes.

Pricing Strategy and Market Penetration

Pricing is influenced by reimbursement policies and competitive pressures. While branded formulations like Integrilin commanded premium pricing, the entrance of generics pressured profit margins. Strategic discounting and value-added services have become tools for market retention.

Market Growth Prospects

The overall market for glycoprotein IIb/IIIa inhibitors is expected to decline gradually as clinical preference shifts towards oral agents, but niche applications in high-risk PCI continue to sustain demand. Forecasts indicate a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, primarily driven by emerging markets and procedural demand.

Regional Variations

The U.S. remains the largest market owing to high PCI volumes and established treatment protocols. European markets show moderate uptake, while emerging economies like China and India are experiencing growth due to increasing cardiovascular disease prevalence and expanding access to interventional cardiology.

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Challenges and Opportunities

Challenges

• Market Erosion: Patent expiry and competition from biosimilars and oral alternatives threaten revenue streams.
• Prescribing Trends: Evolving clinical guidelines favor less invasive and oral therapies, reducing reliance on intravenous GP IIb/IIIa inhibitors.
• Cost Constraints: Healthcare systems prioritize cost-effective treatments, impacting pricing and reimbursement.

Opportunities

• Niche Market Focus: High-risk PCI cases and patients intolerant to oral agents can sustain demand.
• Combination Therapy Protocols: Incorporating eptifibatide into multi-modal treatment strategies may expand its utility.
• Emerging Markets: Rapid urbanization and increasing interventional cardiology procedures in developing regions open new avenues for growth.

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Regulatory and Patent Outlook

Pending patent cliffs, Merck & Co. faces the imperative of lifecycle management strategies—including new formulations, indications, or combinatorial uses—to prolong product relevance. Regulatory approvals for biosimilar versions could further shape the competitive environment.

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Conclusion

Eptifibatide's market dynamics are characterized by an evolving competitive landscape driven by advances in antithrombotic therapy, regulatory shifts, and healthcare system adaptations. While declining in some regions, strategic positioning in high-risk PCI procedures and niche indications sustains its financial trajectory. The future profitability hinges on innovation, regulatory navigation, and aligning with emerging clinical practices.

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Key Takeaways

• Market decline expected: Patent expirations and shifting clinical guidelines erode eptifibatide's market share in favor of oral antiplatelet agents.
• Strategic niche focus: High-risk PCI and specific patient populations remain critical revenue sources.
• Competitive pressures: Biosimilar entrants and new oral therapies challenge profitability, necessitating lifecycle management.
• Emerging markets as growth hubs: Increasing cardiovascular interventions in developing regions offer growth opportunities.
• Innovation imperative: Formulation improvements and expanded indications will be vital for future financial stability.

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FAQs

1. What are the main factors influencing eptifibatide’s declining market share?
The primary factors include patent expiration leading to biosimilar competition, a clinical shift toward oral antiplatelets, and evolving guidelines favoring less invasive therapies.

2. Which regions offer the most growth potential for eptifibatide?
Emerging markets such as China, India, and parts of Southeast Asia present significant growth opportunities due to expanding interventional cardiology services and increasing adoption of PCI.

3. How does eptifibatide compare cost-wise to competitors?
Branded eptifibatide, under Integrilin, commands premium pricing, but biosimilars and generics are expected to reduce costs, impacting profitability.

4. Are there recent advancements or new indications for eptifibatide?
Research continues into combination therapies and specific high-risk procedural uses, but no new major indications are currently approved.

5. What strategies can manufacturers adopt to sustain eptifibatide’s market relevance?
Lifecycle management through new formulations, exploring additional indications, strategic alliances, and expanding into emerging markets can help sustain its relevance.

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Sources:
[1] Global Pharmaceutical Market Analysis Reports, 2022.
[2] ClinicalTrials.gov — Eptifibatide studies and guidelines.
[3] Company filings and patent documentation, Merck & Co.
[4] Market forecasts from IQVIA and EvaluatePharma, 2023.
[5] Regulatory guidelines from FDA and EMA on antithrombotic agents.