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OMEGA-3-ACID ETHYL ESTERS

ANDA

OMEGA-3-ACID ETHYL ESTERS | A211355 | SOFGEN PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: LOVAZA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.1725

per ea

Lowest NADAC/Unit

$0.1725

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62135078012OMEGA-3 ETHYL ESTERS 1 GM CAP	$0.1725	EA	Generic	—	2026-06-17

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

API Supply Chain10 active DMFs3 inactive

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

CRODA EUROPE LTDOMEGA-3-ACID ETHYL ESTERS

DMF 221062008

HUATAI BIOPHARM INCOMEGA-3-ACID ETHYL ESTERS USP

DMF 222852008

CHEMPORT INCOMEGA-3-ACID ETHYL ESTERS

DMF 253422011

BASF ASOMEGA-3-ACID ETHYL ESTERS

DMF 260562012

KINOMEGA BIOPHARM INCOMEGA-3-ACID ETHYL ESTERS

DMF 265702012

CHEMO IBERICA SAOMEGA-3-ACID ETHYL ESTERS

DMF 282462014

BASF ASOMEGA-3-ACID ETHYL ESTERS CAPSULES

DMF 291922015

SHANDONG YUWANG PHARMACEUTICAL CO LTDOMEGA-3-ACID ETHYL ESTERS

DMF 353012020

SICHUAN GOWELL PHARMACEUTICAL CO LTDOMEGA-3-ACID ETHYL ESTERS 90

DMF 419372025

SHANDONG XINHUA PHARMACEUTICAL CO LTDOMEGA-3-ACID ETHYL ESTERS 90

DMF 425422025

OLON SPAInactiveOMEGA-3-ACID ETHYL ESTERS

DMF 222842008

HUATAI BIOPHARM INCInactiveOMEGA-3-ACID ETHYL ESTERS (NON-STERILE, BULK FORM)

DMF 265592012

SKUNY BIOSCIENCE CO LTDInactiveOMEGA-3-ACID ETHYL ESTERS 90

DMF 280452014

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

Products (1)

#001 — 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 10, 2019

No patent or exclusivity listings for this strength.