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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	D. Nev.	2018-08-24	Terminated 2020-05-04	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.4469

per ea

Lowest NADAC/Unit

$0.3522

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
43598026704ICOSAPENT ETHYL 1 GRAM CAPSULE	$0.4469	EA	Generic	—	2026-06-17
43598074672ICOSAPENT ETHYL 0.5 GM CAPSULE	$0.3522	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$130.61

Highest Price

$130.61

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
43598-0267-04ICOSAPENT ETHYL 1GM CAP	$130.61	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 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

SICHUAN GOWELL PHARMACEUTICAL CO LTDICOSAPENT ETHYL

DMF 438342026

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