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ICOSAPENT ETHYL

ANDA

ICOSAPENT ETHYL | A209499 | DR REDDYS LABORATORIES INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VASCEPA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Amarin Pharma, Inc. et al v. Dr. Reddy's Laboratories, Inc. et al 2:2018cv01596 12 patentsANDA 209499icosapent ethyl	NVD	2018-08-24	Terminated 2020-05-04	—

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
Aug 30, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 7, 2020

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 8, 2023