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
University of Alabama at Birmingham	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	020718-001	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
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
Canada	2573307	INHIBITEURS D'AGREGATION PLAQUETTAIRE (USE OF PLATELET AGGREGATION INHIBITORS)
Finland	104364
Japan	H07509691
Austria	173739
Norway	312965

Supplementary Protection Certificates for INTEGRILIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Integrilin (Eptifibatide)

Last updated: January 23, 2026

Summary

Integrilin (generic name: eptifibatide) is a glycoprotein IIb/IIIa inhibitor indicated primarily for the treatment of acute coronary syndromes (ACS) and percutaneous coronary interventions (PCI). The drug has garnered sustained demand within interventional cardiology, driven by its efficacy in reducing thrombotic events. Its market trajectory depends on various factors including clinical guidelines, competing therapies, patent status, regulatory approvals, and evolving cardiovascular care paradigms.

This analysis dissects Integrilin’s market dynamics, influences, revenue performance, licensing/licensed sectors, and future outlooks, providing stakeholders with comprehensive insights into its financial trajectory.

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What Are the Key Market Drivers for Integrilin?

Driver	Details / Impact
Clinical Efficacy	Proven to reduce ischemic complications during PCI and ACS; supported by landmark trials (EPIC, PURSUIT).
Regulatory Approvals	Approved by FDA (1998) with specific indications for ACS and PCI, solidifying market access.
Guideline Recommendations	Integrated into ACC/AHA guidelines for management of ACS, enhancing clinical adoption.
Advancements in Interventional Cardiology	Growing PCI procedures worldwide increase demand; the global PCI volume was over 1 million annually (pre-pandemic).
Market Penetration	Strong presence in developed markets (U.S., Europe), with expanding use in emerging markets via licensing/licensed distributors.

Challenge	Details / Impact
Competition	Other GP IIb/IIIa inhibitors (e.g., abciximab, tirofiban); antiplatelet agents such as P2Y12 inhibitors (Clopidogrel, Ticagrelor).
Pricing Pressure	Cost containment measures and generic competition for similar products.
Safety Profile	Risks of bleeding limit use in certain settings; newer antiplatelet agents are sometimes preferred.

Market Size and Revenue Trends

Indicator	Data Point	Source/Notes
Global Market Size (2023)	Estimated at approx. USD 600–700 million	Based on IQVIA and EvaluatePharma reports.
U.S. Market Share (2023)	Approx. USD 330 million	Reflects high adoption due to early approval and established use.
Year-over-Year Growth (2020–2023)	CAGR ~3–4%	Slow but steady growth driven by increased PCI volume and incremental adoption.
Major Revenue Contributors	Cardiology hospitals, cath labs in North America and Europe	Clinical preference and insurance coverage aid sustained revenue.

Manufacturing and Patent Landscape

Patent Status	Details	Implications
Patent Expiration	U.S. patent expired in 2014, generic versions available	Price competition and potential erosion of margins.
Manufacturing	Produced by companies like Merck (original), with generics by multiple manufacturers	Price sensitivity increases with generic availability.

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Competitive Landscape and Substitutes

Competitors	Description	Market Focus	Strengths	Weaknesses
Abciximab (ReoPro)	Monoclonal antibody GP IIb/IIIa inhibitor	PCI, ACS	Proven efficacy, FDA-approved	Higher bleeding risk, cost
Tirofiban	Non-peptide GP IIb/IIIa inhibitor	Acute care	Easier administration	Slightly less effective in some settings
P2Y12 inhibitors (e.g., Ticagrelor)	Oral antiplatelet agents	ACS, PCI	Oral, convenient	Different mechanism, possibly preferred in some cases

| Market Share (2023) | Estimated | Based on efficacy and physician preferences; Integrilin maintains a niche in complex cases. |

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Regulatory Environment and Policy Impact

Key Regulations	Details	Impact
FDA	Approved for ACS and PCI indications	Stable access in U.S. market, influence on international regulators
EMA (Europe)	Approved, with variations, for similar indications	Equally vital for market penetration in EU
Pricing & Reimbursement	Varies by country; influenced by HTA bodies like NICE (UK)	May impact volume and revenue potential

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Future Outlook and Trajectory

Projection Factor	Expected Impact	Details
Growing PCI Volume (Global)	Increased demand	Estimated CAGR of 4–5% over the next 5 years.
Introduction of Biosimilars	Price competition	Could further depress prices post-patent expiry, affecting revenue.
Emerging Markets	Expansion opportunities	Rapidly expanding healthcare infrastructure in Asia-Pacific, Latin America.
Development of Alternative Therapies	Potential market share erosion	New oral agents and biologics emerging as rivals.
Implementation of Minimal Bleeding Risk Strategies	Market adaptation	Combining Integrilin with other agents to optimize safety could refine use cases.

Forecast (2025–2030)	Summary
Revenues	Expected to decline marginally due to competition but stabilize in specific niches
Market Shares	Likely confined to high-risk or complex PCI cases
Growth Rate	CAGRs around 1–2%, stabilizing as generic competition intensifies

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Comparison: Integrilin Versus Competing Agents

Parameter	Integrilin (Eptifibatide)	Abciximab	Tirofiban	P2Y12 inhibitors (e.g., Ticagrelor)
Administration	IV	IV	IV	Oral
Indications	ACS, PCI	ACS, PCI	ACS, PCI	ACS, PCI
Approval Year	1998	1994	1993	2011 (Ticagrelor)
Efficacy	High in complex cases	High, especially in high-risk interventions	Comparable in some settings	Varies based on formulation and patient profile
Safety Profile	Bleeding risk (moderate)	Higher bleeding risk	Lower bleeding risk	Lower bleeding risk

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Key Factors Influencing Market Trajectory

• Clinical Adoption: Continued integration into guidelines for specific high-risk interventions sustains demand.
• Pricing & Reimbursement Policies: Cost containment in health systems impacts volume.
• Patent & Licensing: Generic competition post-patent expiration pressures revenue.
• Technological Advances: Newer antithrombotic agents may substitute Integrilin in some roles.
• Broader Cardiovascular Treatment Trends: Shift toward oral, dual-antiplatelet therapies may reduce reliance on IV agents.

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Key Takeaways

• Stable but declining revenues: Integrilin's revenues are gradually declining due to patent expiration and competition; however, niche use in complex PCI ensures a baseline demand.
• Market expansion opportunities: Emerging markets and increased PCI procedures support growth potential.
• Competitive landscape: Generic versions and alternatives like oral P2Y12 inhibitors intensify price competition.
• Regulatory and policy impacts: Reimbursement policies and clinical guidelines significantly influence market health.
• Future trajectory: Slight declines expected, with market stabilization in specialized high-risk sectors.

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FAQs

1. How has Integrilin’s patent expiration affected its market performance?
Patent expiry in 2014 introduced generic competitors, leading to price reductions and a decline in revenue share; however, high-risk, complex PCI cases still sustain niche demand.

2. What clinical guidelines influence Integrilin’s use today?
Recent guidelines from ACC/AHA emphasize the role of IV glycoprotein IIb/IIIa inhibitors in specific high-risk or complex PCI scenarios, maintaining Integrilin’s relevance in particular niches.

3. How does Integrilin compare to newer oral antiplatelet agents?
While oral agents like Ticagrelor provide convenience and are favored for routine ACS management, Integrilin remains standard in certain interventional procedures due to its rapid action and efficacy in high-risk or refractory cases.

4. What is the revenue outlook for Integrilin over the next five years?
Revenues are projected to decline modestly (approx. 1–2% CAGR) due to patent expiration and market competition, stabilizing primarily in niche sectors.

5. Are there any recent regulatory changes impacting Integrilin?
No significant recent regulatory modifications have altered Integrilin’s approved indications; however, evolving guidelines and reimbursement policies continue to influence its market access.

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References

[1] IQVIA, "Global Cardiovascular Market Report," 2023.
[2] EvaluatePharma, "Pharmaceutical Market Forecasts," 2023.
[3] American College of Cardiology/American Heart Association Guidelines, 2022 update.
[4] U.S. FDA, "Drug Approvals and Labeling," 1998–2023.
[5] European Medicines Agency (EMA), "Medicines Timeline," 2023.