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Generated: May 29, 2017

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Omega-3-acid ethyl esters - Generic Drug Details

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What are the generic drug sources for omega-3-acid ethyl esters and what is the scope of omega-3-acid ethyl esters patent protection?

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. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Drug Master File Entries: see list13
Suppliers / Packagers: see list18
Clinical Trials: see list2,172
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
omega-3-acid ethyl esters
CAPSULE;ORAL204940-001Nov 27, 2015ABRXNoNo► Subscribe► Subscribe
Par Pharm Inc
omega-3-acid ethyl esters
CAPSULE;ORAL091018-001Jun 24, 2014ABRXNoNo► Subscribe► Subscribe
Apotex Inc
omega-3-acid ethyl esters
CAPSULE;ORAL090973-001Sep 30, 2014ABRXNoNo► Subscribe► Subscribe
Smithkline Beecham
omega-3-acid ethyl esters
CAPSULE;ORAL021654-001Nov 10, 2004ABRXYesYes► Subscribe► Subscribe
omega-3-acid ethyl esters type a
CAPSULE;ORAL204977-001Apr 23, 2014RXYesYes► Subscribe► Subscribe
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