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ICOSAPENT ETHYL

ANDA

ICOSAPENT ETHYL | A209525 | TEVA PHARMACEUTICALS USA

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VASCEPA(TE code: AB)

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
00480012789ICOSAPENT ETHYL 1 GRAM CAPSULE	$0.4469	EA	Generic	—	2026-06-17
00480012649ICOSAPENT ETHYL 500 MG 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

$101.02

Highest Price

$101.02

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0046-12ICOSAPENT ETHYL 1GM CAP	$101.02	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
Oct 30, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 11, 2020

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 11, 2020