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, Hong Kong, Hybio, 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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	36
Patent Applications:	4,776
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
Baylor College of Medicine	Phase 1/Phase 2
Assiut University	Phase 1/Phase 2
University of Cincinnati	Phase 3

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
Rising	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	204589-001	Apr 18, 2017		DISCN	No	No
Mylan Labs Ltd	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	203258-002	Jul 20, 2018	AP	RX	No	Yes
Amneal Pharms	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	205581-002	Dec 8, 2016		DISCN	No	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
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 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/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

EPTIFIBATIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eptifibatide

Introduction to Eptifibatide

Eptifibatide, marketed under the brand name Integrilin, is a potent platelet aggregation inhibitor used primarily in the management of acute coronary syndromes (ACS) and during percutaneous coronary intervention (PCI). Its role in preventing thrombotic events and reducing the risk of adverse cardiovascular outcomes makes it a crucial component in cardiovascular care.

Market Growth and Projections

The global eptifibatide market is anticipated to expand at a compound annual growth rate (CAGR) of 5.00% from 2023 to 2030. This growth is driven by the increasing incidence of cardiovascular diseases worldwide, such as myocardial infarction and unstable angina, which necessitate the use of antiplatelet therapies like eptifibatide[1].

Key Drivers of Market Growth

Rising Prevalence of Cardiovascular Diseases

The growing prevalence of cardiovascular diseases is a significant driver of the eptifibatide market. As the global population ages and lifestyle factors contribute to increased cardiovascular risk, the demand for effective antiplatelet medications like eptifibatide is expected to rise[1][4].

Efficacy in Acute Coronary Syndromes

Eptifibatide's efficacy in reducing mortality and myocardial infarction in patients with ACS, as demonstrated in trials like PURSUIT and ESPRIT, positions it as a key intervention in cardiovascular care. This efficacy contributes to its widespread adoption in clinical practice[3].

Geographical Expansion

The Asia Pacific region is emerging as a rapidly growing market for eptifibatide, driven by increasing healthcare expenditures, a rising prevalence of cardiovascular risk factors, and expanding access to interventional cardiology services. This region is expected to play a significant role in the market's future growth[1][4].

Market Restraints

Economic Constraints and Affordability

Despite its efficacy, the eptifibatide market faces significant restraints due to economic constraints and affordability challenges. The high cost associated with eptifibatide therapy poses a barrier to its widespread adoption, particularly in regions with limited financial resources and healthcare budgets[1].

Impact of the COVID-19 Pandemic

The COVID-19 pandemic has had a notable impact on the eptifibatide market. Disruptions in healthcare access, reduced elective procedures, and supply chain challenges have affected the demand for antiplatelet agents, including eptifibatide. However, as healthcare systems recover, the market is expected to rebound[1].

Regional Market Dynamics

North America

North America is the largest and most influential region in the eptifibatide market, commanding a substantial 41% market share. The region's well-established healthcare infrastructure and early adoption of advanced medical therapies contribute to its dominance. The focus on cutting-edge medical interventions and proactive cardiovascular care ensures sustained demand for eptifibatide in this region[1].

Asia Pacific

The Asia Pacific region is the fastest-growing hub in the eptifibatide market, projected to hold a significant market share by 2030. Factors such as increasing healthcare investments, a burgeoning population, and rising incidence of cardiovascular diseases drive the demand for eptifibatide in this region[1][4].

Competitive Landscape

The eptifibatide market is highly competitive, with major global players like Merck & Co., Inc., Pfizer Inc., and Bristol-Myers Squibb dominating the market. These companies invest heavily in research and development to enhance the efficacy and safety profiles of eptifibatide, expand indications through clinical trials, and secure regulatory approvals in key markets[4].

Regional Players and Generic Competition

Regional players, particularly in Asia-Pacific and Latin America, play a crucial role by offering cost-effective alternatives and localized marketing strategies. Generic competition also poses a challenge to branded manufacturers, driving down prices and expanding patient access to eptifibatide injections[4].

Cost-Effectiveness and Economic Analysis

Studies like the PURSUIT trial have demonstrated the cost-effectiveness of eptifibatide therapy. The incremental cost-effectiveness ratio for eptifibatide therapy in US patients was found to be $16,491 per year of life saved, making it economically attractive by conventional standards[2].

Regulatory Support

Recent regulatory support, such as the announcement by the Centers for Medicare and Medicaid Services (CMS) to cover eptifibatide for the treatment of ACS in patients undergoing PCI, further bolsters the market growth of eptifibatide[1].

Future Outlook and Opportunities

The future outlook for the eptifibatide market remains promising, driven by advancements in interventional cardiology, increasing procedural volumes of PCI, and the introduction of next-generation antithrombotic therapies. Opportunities lie in leveraging digital health technologies, real-world evidence generation, and personalized medicine approaches to optimize patient care and clinical outcomes[4].

Challenges and Strategic Adaptation

Despite the positive outlook, the market faces challenges such as generic competition, regulatory complexities, and healthcare cost containment measures. Strategic adaptation and innovation, including advancements in drug delivery systems and formulation technologies, are necessary to sustain growth and maximize market potential[4].

Key Takeaways

• The global eptifibatide market is projected to grow at a CAGR of 5.00% from 2023 to 2030.
• The market is driven by the rising incidence of cardiovascular diseases and the efficacy of eptifibatide in managing ACS.
• Economic constraints and affordability challenges are significant restraints.
• North America and the Asia Pacific region are key markets, with the latter being the fastest-growing.
• The competitive landscape is dominated by global pharmaceutical companies, with regional players and generic competition playing important roles.
• Regulatory support and cost-effectiveness analyses support the market growth.

FAQs

Q: What is the projected CAGR for the global eptifibatide market from 2023 to 2030? A: The global eptifibatide market is expected to expand at a CAGR of 5.00% from 2023 to 2030[1].

Q: What are the primary drivers of the eptifibatide market? A: The primary drivers include the rising prevalence of cardiovascular diseases, the efficacy of eptifibatide in managing ACS, and geographical expansion, particularly in the Asia Pacific region[1][4].

Q: How has the COVID-19 pandemic affected the eptifibatide market? A: The pandemic has caused disruptions in healthcare access, reduced elective procedures, and supply chain challenges, affecting the demand for antiplatelet agents like eptifibatide[1].

Q: Which region dominates the eptifibatide market? A: North America is the largest and most influential region, commanding a substantial 41% market share[1].

Q: What are the key challenges facing the eptifibatide market? A: The market faces challenges such as economic constraints, affordability issues, generic competition, and regulatory complexities[1][4].

Cited Sources

1. Cognitive Market Research: "Eptifibatide Market Report 2024 (Global Edition)"
2. PubMed: "Cost-effectiveness of platelet glycoprotein IIb/IIIa inhibition ... - PubMed"
3. European Medicines Agency: "INTEGRILIN, INN-eptifibatide - European Medicines Agency"
4. Data Horizon Research: "Eptifibatide Injection Market Size, Share, Growth, Statistics Report ..."