Eptifibatide

Sold as Integrilin. Every FDA application for this active ingredient: 1 branded and 14 generic.

As of Nov 14, 2026, FDA lists 15 applications for Eptifibatide (sold as Integrilin), first approved May 18, 1998, with 3 new uses approved and 0 published complete response letters.

First approved: May 18, 1998
Applications: 15
New uses approved: 3
Complete response letters: 0
First approved in the EU: Jul 1, 1999

Approvals in the EU (EMA)

First approved in the EU 13 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Eptifibatide Accord, genericAccord Healthcare S.L.U. · Jan 11, 2016
Integrilin, new substanceGlaxoSmithKline Trading Services Limited · Jul 1, 1999 · withdrawn

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Eptifibatide for Extended Window Ischemic Stroke After ThrombolysisAcute Ischemic Stroke · Xinqiao Hospital of Chongqing	Phase 3	Not yet recruiting	Jan 16, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 18, 1998	IntegrilinNDA 20718 · New molecular entity	Msd Sub Merck	22	Discontinued
Jun 5, 2015	EptifibatideANDA 91555	Teva Pharms USA	0	Discontinued
Jun 12, 2015	EptifibatideANDA 90854	Teva Pharms USA	0	Marketed
Dec 8, 2015	EptifibatideANDA 206127	Eugia Pharma	1	Marketed
Apr 18, 2017	EptifibatideANDA 204589	Rising	0	Discontinued
Nov 6, 2017	EptifibatideANDA 205557	Accord Hlthcare	1	Discontinued
Mar 7, 2018	EptifibatideANDA 204693	Sagent Pharms Inc	1	Marketed
Jul 20, 2018	EptifibatideANDA 203258	Mylan Labs Ltd	1	Marketed
Nov 23, 2018	EptifibatideANDA 208554	Baxter Hlthcare Corp	1	Marketed
Jan 25, 2019	EptifibatideANDA 209864	Hainan Poly	1	Marketed
Mar 11, 2019	EptifibatideANDA 204362	Usv	0	Discontinued
Mar 14, 2019	EptifibatideANDA 204361	Usv	0	Discontinued
Mar 20, 2020	EptifibatideANDA 207864	Hybio	0	Discontinued
Sep 7, 2021	EptifibatideANDA 213081	Quagen	1	Marketed
May 9, 2024	EptifibatideANDA 213599	Meitheal	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA