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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. Seventeen 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 / Packagers: see list17
Clinical Trials: see list2,162
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:omega-3-acid ethyl esters at DailyMed

Pharmacology for Ingredient: omega-3-acid ethyl esters

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Trygg
OMTRYG
omega-3-acid ethyl esters type a
CAPSULE;ORAL204977-001Apr 23, 2014RXYesYes► subscribe► subscribe
Teva Pharms Usa
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL091028-001Apr 7, 2014RXNoNo► subscribe► subscribe
Apotex Inc
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL090973-001Sep 30, 2014RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: omega-3-acid ethyl esters

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► subscribe
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 20045,698,594► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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