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ICOSAPENT ETHYL

ANDA

ICOSAPENT ETHYL | A209457 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VASCEPA(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc., et al. 1:2020cv01630 3 patentsANDA 209457icosapent ethyl (ethyl icosapentate, ethyl eicosapentaenoate)	D. Del.	2020-11-30	Active	—
Amarin Pharma Inc. et al v. Hikma Pharmaceuticals USA Inc. et al 2:2016cv02525 14 patentsANDA 209457icosapent ethyl	NVD	2016-10-31	Terminated 2020-03-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

FINORGA SASICOSAPENT ETHYL

DMF 271822013

HUATAI PHARMA INCICOSAPENT ETHYL

DMF 349592020

SICHUAN GOWELL PHARMACEUTICAL CO LTDICOSAPENT ETHYL

DMF 358542021

AK BIOPHARM CO LTDICOSAPENT ETHYL

DMF 368222022

KINOMEGA BIOPHARM INCICOSAPENT ETHYL

DMF 390402023

SKUNY BIOSCIENCE CO LTDInactiveICOSAPENT ETHYL

DMF 284222014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 4, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 21, 2020

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 8, 2023