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. Nine 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:	70
Clinical Trials:	16
Patent Applications:	4,746
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	020718-002	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

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/004104 Eptifibatide 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/000230 Integrilin 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
European Patent Office	0477295	INHIBITEURS DE L'AGREGATION DES PLAQUETTES (PLATELET AGGREGATION INHIBITORS)
Canada	2059124	INHIBITEURS D'AGREGATION DE PLAQUETTES (PLATELET AGGREGATION INHIBITORS)
Finland	104364

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	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	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

INTEGRILIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INTEGRILIN (Eptifibatide)

Introduction

INTEGRILIN, also known as eptifibatide, is a potent platelet aggregation inhibitor used primarily in the management of acute coronary syndromes (ACS) and to prevent adverse cardiovascular events. Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical product.

Mechanism of Action and Clinical Use

Eptifibatide works by inhibiting the glycoprotein IIb/IIIa receptor on platelet surfaces, preventing platelet aggregation and thereby reducing the risk of thrombotic events. This mechanism makes it a vital component in the treatment of conditions such as myocardial infarction and unstable angina[4].

Market Drivers

The global market for eptifibatide is driven by several key factors:

Rising Incidence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases worldwide is a significant driver for the demand of eptifibatide. As the global population ages and lifestyle factors contribute to higher rates of heart disease, the need for effective antiplatelet therapies like eptifibatide grows[4].

Healthcare Infrastructure and Technological Advancements

Advancements in healthcare infrastructure and the adoption of advanced medical technologies enhance the ability to diagnose and manage cardiovascular conditions effectively. This aligns with the contemporary approach to cardiovascular care, where precision and efficacy are paramount[4].

Regulatory Support

Recent regulatory approvals and coverage decisions, such as the announcement by the Centers for Medicare and Medicaid Services (CMS) to cover eptifibatide for the treatment of ACS in patients undergoing percutaneous coronary intervention (PCI), further bolster the market[4].

Market Size and Growth

The global eptifibatide market is expected to expand at a compound annual growth rate (CAGR) of 5.00% from 2023 to 2030. This growth is driven by the increasing demand for antiplatelet therapies and the expanding healthcare infrastructure, particularly in regions like North America and the Asia Pacific[4].

Regional Market Dynamics

• North America: This region commands a substantial 41% market share due to a high prevalence of cardiovascular diseases, well-established healthcare infrastructure, and early adoption of advanced medical therapies. The region is expected to maintain its dominance in the eptifibatide market[4].
• Asia Pacific: This region is the fastest-growing hub in the eptifibatide market, driven by an increasing incidence of cardiovascular diseases, a burgeoning population, and rising healthcare investments. By 2030, the market size in this region is anticipated to reach significant levels[4].

Financial Performance

Historical Sales

In 2003, INTEGRILIN achieved $284 million in U.S. sales and $306 million worldwide, in partnership with Schering-Plough Corporation. This marked a significant milestone in its market share leadership in the glycoprotein IIb/IIIa inhibitor segment[5].

Forecasted Sales

The market report indicates that the global eptifibatide market will continue to grow, driven by the factors mentioned above. While specific forecasted sales figures for recent years are not provided, the overall trend suggests sustained growth due to increasing demand and expanding market reach[4].

Impact of the COVID-19 Pandemic

The COVID-19 pandemic had a notable impact on the eptifibatide market. Disruptions in healthcare access, reduced elective procedures, and supply chain challenges led to a decline in demand for antiplatelet agents, including eptifibatide. However, as healthcare systems recover and prioritize cardiovascular care, the market is expected to rebound[4].

Competitive Landscape

The eptifibatide market is competitive, with several key players focusing on strategy building and product portfolio expansion. Companies like Accord Healthcare and Baxter International Inc. are among those actively involved in strengthening their market presence[4].

SWOT Analysis

Strengths

• Eptifibatide's efficacy in preventing platelet aggregation and reducing thrombotic events positions it as a key intervention in cardiovascular care.
• Strong market presence in regions like North America and the Asia Pacific.
• Regulatory support and coverage decisions enhance its market viability.

Weaknesses

• The drug's market can be affected by generic competition and patent expirations.
• Disruptions in healthcare access and supply chains can impact sales.

Opportunities

• Growing prevalence of cardiovascular diseases offers a significant market opportunity.
• Advancements in healthcare infrastructure and technologies can increase adoption.
• Expanding into new regions and markets can further grow sales.

Threats

• Competition from other antiplatelet agents and emerging therapies.
• Economic and regulatory changes can impact market dynamics.

Recent Developments

In November 2023, Merck announced positive results of its Phase III trial evaluating INTEGRILIN in patients with acute coronary syndrome who are at high risk of bleeding. This development is expected to further solidify the drug's position in the market[4].

Key Takeaways

• Market Growth: The eptifibatide market is expected to grow at a CAGR of 5.00% from 2023 to 2030.
• Regional Dominance: North America and the Asia Pacific are key regions driving market growth.
• Clinical Significance: Eptifibatide's efficacy in preventing platelet aggregation makes it a crucial component in cardiovascular care.
• Regulatory Support: Recent regulatory approvals and coverage decisions support market growth.
• Competitive Landscape: The market is competitive, with several key players focusing on strategy and product portfolio expansion.

FAQs

What is the primary use of INTEGRILIN (eptifibatide)?

INTEGRILIN is primarily used to prevent platelet aggregation and reduce the risk of thrombotic events in patients with acute coronary syndromes (ACS).

How does eptifibatide work?

Eptifibatide works by inhibiting the glycoprotein IIb/IIIa receptor on platelet surfaces, preventing platelet aggregation.

What are the key drivers of the eptifibatide market?

The key drivers include the rising incidence of cardiovascular diseases, advancements in healthcare infrastructure, and regulatory support.

How did the COVID-19 pandemic impact the eptifibatide market?

The pandemic led to disruptions in healthcare access, reduced elective procedures, and supply chain challenges, resulting in a temporary decline in demand for eptifibatide.

Which regions are expected to drive the growth of the eptifibatide market?

North America and the Asia Pacific are expected to be the key regions driving market growth.

What recent developments have impacted the market for INTEGRILIN?

Recent positive results from a Phase III trial evaluating INTEGRILIN in patients with acute coronary syndrome who are at high risk of bleeding are expected to further solidify the drug's market position.

Sources

1. Integrilin - Drug Insight, 2019 - ResearchAndMarkets.com
2. GSK Form 20F 2006 - GSK
3. Novel dosing regimen of eptifibatide in planned coronary stent placement - The Lancet
4. Eptifibatide Market Report 2024 (Global Edition) - Cognitive Market Research
5. Millennium Pharmaceuticals, Inc. 2003 Annual Report - Millennium Pharmaceuticals, Inc.