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:	3,909
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
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 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
Japan	H07509691
Hungary	T59835
Australia	4118293
Israel	105533	Stable injectable peptide compositions and method of their preparation
European Patent Office	0477295	INHIBITEURS DE L'AGREGATION DES PLAQUETTES (PLATELET AGGREGATION INHIBITORS)
Germany	19975072
Norway	982249

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