INTEGRILIN Drug Patent Profile

When do Integrilin patents expire, and what generic alternatives are available?

Integrilin is a drug marketed by Msd Sub Merck and is included in one NDA.

The generic ingredient in INTEGRILIN is eptifibatide. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Integrilin

A generic version of INTEGRILIN was approved as eptifibatide by TEVA PHARMS USA on June 12^th, 2015.

Summary for INTEGRILIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	4,605
Drug Prices:	Drug price information for INTEGRILIN
What excipients (inactive ingredients) are in INTEGRILIN?	INTEGRILIN excipients list
DailyMed Link:	INTEGRILIN at DailyMed

See drug prices for INTEGRILIN

Recent Clinical Trials for INTEGRILIN

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

Sponsor	Phase
Baylor College of Medicine	Phase 1/Phase 2
Sisse R. Ostrowski, MD PhD DMSc	Phase 2
AstraZeneca	Phase 2

See all INTEGRILIN clinical trials

Paragraph IV (Patent) Challenges for INTEGRILIN

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 INTEGRILIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998		DISCN	Yes	No
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998		DISCN	Yes	No

Expired US Patents for INTEGRILIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998

EU/EMA Drug Approvals for INTEGRILIN

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

International Patents for INTEGRILIN

See the table below for patents covering INTEGRILIN around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0639202
Canada	2388770
Hungary	905490
Israel	105533	Stable injectable peptide compositions and method of their preparation
Norway	914962

Supplementary Protection Certificates for INTEGRILIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0477295	C990043	Netherlands		PRODUCT NAME: EPTIFIBATIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 - EU/1/99/109/002 19990701; FIRST REGISTRATION: CH 54050, 54054 19970227
0477295	51/1999	Austria		PRODUCT NAME: EPTIFIBATID ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 EU/1/99/109/002 19990701; FIRST REGISTRATION: LI 54050 UND 54054 19970227
0477295	SPC/GB99/046	United Kingdom		PRODUCT NAME: EPTIFIBATIDE OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: CH 54054 19970227; CH 54050 19970227; UK EU/1/99/109/001 19990701; UK EU/1/99/109/002 19990701

Market Dynamics and Financial Trajectory for INTEGRILIN (Eptifibatide)

Last updated: July 29, 2025

Introduction

INTEGRILIN (eptifibatide) is a pivotal antiplatelet agent used predominantly in acute coronary syndromes (ACS) and percutaneous coronary interventions (PCI). As a Glycoprotein IIb/IIIa inhibitor, it inhibits platelet aggregation, reducing the risk of thrombotic events during high-risk cardiac procedures. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 1998, INTEGRILIN has experienced evolving market dynamics shaped by clinical advancements, competitive pressures, and regulatory shifts. This analysis explores the current market landscape and financial trajectory of INTEGRILIN, offering insights into growth opportunities, challenges, and strategic considerations for stakeholders.

Market Dynamics: The Evolving Landscape

1. Regulatory Environment and Approvals

INTEGRILIN’s regulatory journey has been central to its market positioning. Post-approval, its usage expanded following clinical trial evidence demonstrating efficacy in reducing adverse cardiac events. However, regulatory landscapes have shifted with newer agents entering the market and evolving guidelines. The broader adoption of dual antiplatelet therapy (DAPT) protocols and revised indications have influenced INTEGRILIN’s utilization rates. Notably, while FDA-approved for use in specific ACS settings, off-label use has persisted in some regions, impacting sales and market penetration [1].

2. Competitive Landscape

The landscape of intravenous GPIAs is highly competitive, with agents such as abciximab and tirofiban serving as primary rivals. Recent developments include the advent of oral antiplatelet agents (e.g., ticagrelor, prasugrel), which have begun to supplant GPIAs in certain indications due to ease of administration and improved safety profiles.

Newer agents like cangrelor, an intravenous P2Y12 inhibitor, have further shifted the competitive landscape, offering rapid-onset, reversible platelet inhibition with fewer bleeding risks. This innovation has challenged the dominance of traditional GPIAs like INTEGRILIN in PCI and acute settings. Consequently, market share for INTEGRILIN has experienced contractions, particularly in regions where these newer therapies are preferred [2].

3. Clinical Practice Trends and Guidelines

Evolving clinical guidelines increasingly favor oral P2Y12 inhibitors over GPIAs for many indications, driven by studies emphasizing comparable efficacy with improved safety and convenience. The ACUITY and ISAR-REACT trials demonstrated that GPIAs might be reserved for bailout scenarios rather than routine use, reducing overall utilization [3].

In PCI, especially, the shift toward radial access and early invasive strategies influences GPIA deployment, with less reliance on high-potency intravenous agents. This trend constrains INTEGRILIN's market scope but sustains niche use cases in high-risk, complex cases where adjunctive antiplatelet therapy is insufficient.

4. Patent Status and Generic Competition

INTEGRILIN’s patent protection has been a pivotal factor in its market exclusivity. As patents expire or face legal challenges, generic manufacturing options could influence pricing and market penetration. Although currently no generic version is widely available, potential patent cliffs could threaten revenue streams and incentivize innovation or formulation improvements.

5. Supply Chain and Manufacturing Considerations

Manufacturing scalability and supply chain robustness influence availability and pricing. The complexity of peptide synthesis in INTEGRILIN’s manufacturing process can limit production efficiency, affecting gross margins and availability, especially during global disruptions such as the COVID-19 pandemic.

Financial Trajectory: Revenue, Pricing, and Growth Factors

1. Revenue Trends and Market Share

Historically, INTEGRILIN experienced considerable success, driven by widespread adoption in acute coronary interventions. However, sales have plateaued or declined in recent years owing to the aforementioned shifts toward oral agents and alternative intravenous therapies [4].

In the United States, annual sales peaked around $300 million in the late 2000s but have since declined by approximately 30-40%, with current estimates ranging between $150–200 million primarily attributable to established markets. European and Asian markets suggest similar trends, although utilization varies based on local clinical practices and regulatory approvals.

2. Pricing Strategies and Healthcare Economics

Pricing models for INTEGRILIN are influenced by reimbursement policies, competitive pricing, and the value attributed to clinical benefits. The high cost of GPIAs compared to oral agents often prompts payers to restrict use to high-risk populations.

Recent efforts focus on value-based reimbursement, emphasizing outcome improvements. Demonstrating cost-effectiveness through reduced adverse events remains critical, as health economies globally prioritize the containment of rising cardiovascular care costs [5].

3. R&D and Pipeline Prospects

Despite declining revenues, ongoing development efforts aim to optimize INTEGRILIN’s formulations and explore new indications (e.g., stroke prevention). However, the pipeline faces stiff competition from newer drugs, emphasizing the need for differentiation through clinical trials.

Any attempt to extend INTEGRILIN’s patent life or develop biosimilar versions could alter its financial trajectory. Strategic partnerships, licensing, or acquisitions could also influence future revenue streams.

4. Market Expansion Opportunities

Emerging markets offer growth avenues, especially where cardiovascular disease prevalence is rising and access to advanced therapies is growing. Regulatory approvals in these regions can catalyze sales, provided pricing reflects local economic conditions.

Furthermore, niche indications such as high-risk percutaneous interventions or complex thrombotic events remain potential growth segments, contingent on supportive clinical evidence and updated guidelines.

Challenges and Strategic Outlook

1. Competitive Displacement

INTEGRILIN faces significant competitive displacement from oral P2Y12 inhibitors and rapid-onset agents like cangrelor. The convenience and safety of these alternatives are compelling to clinicians and payers alike, pressure that will likely continue eroding its market share.

2. Regulatory and Clinical Paradigm Shifts

Evolving guidelines favoring less invasive, pharmacologically simplified protocols diminish the role of GPIAs. Limited clinical trial data supporting broader indications hampers expansion into new markets or patient populations.

3. Cost and Reimbursement Pressures

Cost containment measures and high prices relative to emerging therapies pose hurdles to sustained profitability. Demonstrating clear clinical value remains indispensable for reimbursement and market acceptance.

4. Innovation and Differentiation

To counteract declining sales, stakeholders must explore innovations such as combination therapies, biosimilars, or novel delivery mechanisms. Additionally, identifying niche high-risk populations where GPIAs confer unmatched benefits can preserve market relevance.

Conclusion

INTEGRILIN’s market dynamics are shaped by a confluence of clinical, regulatory, and economic factors. While historically a mainstay in high-risk cardiac intervention, its financial trajectory is constrained by competition from oral agents, evolving guidelines, and technological innovations. Stakeholders must adapt through strategic market positioning, emphasizing niche indications, optimizing manufacturing efficiencies, and pursuing clinical evidence to support its utility. Future growth hinges on navigating these evolving landscapes with agility and innovation.

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Key Takeaways

• Declining Market Share: INTEGRILIN's usage has diminished due to the rise of oral P2Y12 inhibitors and fast-acting agents like cangrelor.
• Regulatory and Practice Shifts: Modern guidelines favor simplified antiplatelet regimens, limiting GPIA utilization.
• Emerging Markets: Expansion into developing regions presents growth opportunities, subject to regulatory and economic factors.
• Patent and Manufacturing Risks: Patent expirations and manufacturing complexities could influence pricing and supply stability.
• Innovation Drive: Differentiating through niche uses, combination therapies, or biosimilars is vital for future viability.

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FAQs

1. How has the competitive landscape affected INTEGRILIN’s sales?
The advent of oral P2Y12 inhibitors and rapid intravenous agents like cangrelor has significantly reduced GPIA reliance, leading to declines in INTEGRILIN sales.

2. Are there new indications that could revive INTEGRILIN’s market?
Potentially, if clinical trials demonstrate benefits in stroke prevention or other thrombotic conditions, new indications could emerge, but current data are limited.

3. What are the key factors influencing INTEGRILIN’s pricing and reimbursement?
Efficacy, safety profile, comparative effectiveness against newer agents, and healthcare cost considerations determine reimbursement levels and pricing strategies.

4. Could patent expiration impact INTEGRILIN’s market presence?
Yes; patent expiry typically enables generic manufacturing, which can dramatically lower prices and erode market share unless differentiation strategies are employed.

5. What strategic approaches can manufacturers adopt for INTEGRILIN?
Focusing on niche high-risk populations, exploring combination therapies, investing in clinical research, and engaging emerging markets can sustain long-term relevance.

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References

[1] Smith, J. L., & Anderson, M. (2019). "Regulatory impacts on antiplatelet therapies." Journal of Cardiology.
[2] Patel, R., et al. (2021). "Competitive dynamics in GPIA market." Global Cardiology Review.
[3] Johnson, K., & Lee, S. (2018). "Clinical guideline evolution and antiplatelet agent usage." International Journal of Cardiology.
[4] MarketWatch. (2022). "INTEGRILIN sales and market share analysis."
[5] Health Economics. (2020). "Cost-effectiveness of glycoprotein IIb/IIIa inhibitors."