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:	4,881
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
National Institute of Neurological Disorders and Stroke (NINDS)	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
Teva Pharms Usa	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	091555-001	Jun 5, 2015		DISCN	No	No
Mylan Labs Ltd	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	203258-001	Jul 20, 2018	AP	RX	No	Yes
Mylan Labs Ltd	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	203258-002	Jul 20, 2018	AP	RX	No	Yes
Eugia Pharma	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	206127-001	Dec 8, 2015	AP	RX	No	No
Sagent Pharms Inc	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	204693-001	Mar 7, 2018	AP	RX	No	No
Accord Hlthcare	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	205557-001	Nov 6, 2017		DISCN	No	No
Slate Run Pharma	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	209864-001	Jan 25, 2019	AP	RX	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
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	020718-001	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