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Details for Generic Name: omega-3-acid ethyl esters

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Omega-3-acid ethyl esters is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Apotex Inc, Par Pharm Inc, Teva Pharms Usa, and Trygg, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-four patent family members in twenty-three countries.

There are thirteen drug master file entries for omega-3-acid ethyl esters. Six suppliers are listed for this compound.

Summary for Generic Name: omega-3-acid ethyl esters

Tradenames:3
Patents:1
Applicants:5
NDAs:5
Drug Master File Entries: see list13
Suppliers / Packaging: see list13
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: omega-3-acid ethyl esters

Clinical Trials for: omega-3-acid ethyl esters

Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension
Status: Completed Condition: Hypertriglyceridemia

Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
Status: Completed Condition: Hypertriglyceridemia

Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia
Status: Recruiting Condition: Hyperlipidemia, Familial Combined

Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Status: Completed Condition: Hypertriglyceridemia

An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients
Status: Completed Condition: Hypertriglyceridemia

A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
Status: Completed Condition: Hypertriglyceridemia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL091028-001Apr 7, 2014RXNo<disabled><disabled>
Trygg
OMTRYG
omega-3-acid ethyl esters
CAPSULE;ORAL204977-001Apr 23, 2014RXYes<disabled><disabled>
Apotex Inc
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL090973-001Sep 30, 2014RXNo<disabled><disabled>
Par Pharm Inc
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL091018-001Jun 24, 2014RXNo<disabled><disabled>
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 2004RXYes5,656,667<disabled>YY<disabled>
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International Patent Family for Ingredient: omega-3-acid ethyl esters

Country Document Number Publication Date
Italy1235879Nov 23, 1992
Sweden8902701Feb 12, 1990
Spain2018384Apr 01, 1991
Israel91275Mar 19, 1990
JapanH02104522Apr 17, 1990
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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