OMEGA-3-ACID ETHYL ESTERS Drug Patent Profile

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Omega-3-acid Ethyl Esters is a drug marketed by Amneal Pharms, Apotex, Ascent Pharms Inc, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, Wilshire Pharms Inc, and Zydus Lifesciences. and is included in fifteen NDAs.

The generic ingredient in OMEGA-3-ACID ETHYL ESTERS is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

A generic version of OMEGA-3-ACID ETHYL ESTERS was approved as omega-3-acid ethyl esters by GLW on April 7^th, 2014.

US Patents:	0
Applicants:	13
NDAs:	15
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	73
Drug Prices:	Drug price information for OMEGA-3-ACID ETHYL ESTERS
Drug Sales Revenues:	Drug sales revenues for OMEGA-3-ACID ETHYL ESTERS
DailyMed Link:	OMEGA-3-ACID ETHYL ESTERS at DailyMed

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
National Center for Advancing Translational Sciences (NCATS)	Early Phase 1
The University of Texas Health Science Center at San Antonio	Early Phase 1

Drug Class	Omega-3 Fatty Acid

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOVAZA	Capsules	omega-3-acid ethyl esters	1 g	021654	3	2008-11-10

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	204940-001	Nov 27, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glw	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	212504-001	Aug 19, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	206455-001	Aug 7, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	203893-001	Sep 19, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	215458-001	Nov 15, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wilshire Pharms Inc	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	211345-001	Dec 7, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	090973-001	Sep 30, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration