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Generated: October 20, 2018

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Omega-3-acid ethyl esters - Generic Drug Details

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What are the generic sources for omega-3-acid ethyl esters and what is the scope of omega-3-acid ethyl esters freedom to operate?

Omega-3-acid ethyl esters is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Amneal Pharms, Apotex Inc, Par Pharm Inc, Strides Pharma, Teva Pharms Usa, and Osmotica, and is included in seven 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. Nineteen suppliers are listed for this compound.

Pharmacology for omega-3-acid ethyl esters

US Patents and Regulatory Information for 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
Osmotica OMTRYG omega-3-acid ethyl esters type a CAPSULE;ORAL 204977-001 Apr 23, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Par Pharm Inc OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 091018-001 Jun 24, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for 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;ORAL 021654-001 Nov 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Smithkline Beecham LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Merck
Covington
Medtronic
Mallinckrodt
Citi
Fuji
Boehringer Ingelheim
McKinsey

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