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Omega-3-acid ethyl esters - Generic Drug Details

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Omega-3-acid ethyl esters is the generic ingredient in three branded drugs marketed by Par Pharm Inc, Teva Pharms Usa, Amneal Pharms, Smithkline Beecham, Apotex Inc, and Trygg, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

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

Tradenames:3
Patents:0
Applicants:6
NDAs:6
Drug Master File Entries: see list13
Suppliers / Packaging: see list16
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: omega-3-acid ethyl esters

Clinical Trials for: omega-3-acid ethyl esters

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL090973-001Sep 30, 2014RXNo<disabled><disabled>
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 type a
CAPSULE;ORAL204977-001Apr 23, 2014RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: omega-3-acid ethyl esters

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 20045,502,077<disabled>
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 20045,698,594<disabled>
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