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Last Updated: March 29, 2024

OMEGA-3-ACID ETHYL ESTERS Drug Patent Profile


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When do Omega-3-acid Ethyl Esters patents expire, and when can generic versions of Omega-3-acid Ethyl Esters launch?

Omega-3-acid Ethyl Esters is a drug marketed by Amneal Pharms, Apotex, Ascent Pharms Inc, Bionpharma, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Slayback Pharma Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, and Zydus. and is included in fifteen NDAs.

The generic ingredient in OMEGA-3-ACID ETHYL ESTERS is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Omega-3-acid Ethyl Esters

A generic version of OMEGA-3-ACID ETHYL ESTERS was approved as omega-3-acid ethyl esters by GLW on April 7th, 2014.

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Drug patent expirations by year for OMEGA-3-ACID ETHYL ESTERS
Drug Prices for OMEGA-3-ACID ETHYL ESTERS

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Drug Sales Revenue Trends for OMEGA-3-ACID ETHYL ESTERS

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Recent Clinical Trials for OMEGA-3-ACID ETHYL ESTERS

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SponsorPhase
Sohag UniversityPhase 2/Phase 3
Aga Khan University Hospital, PakistanN/A
Jinnah Postgraduate Medical CentreN/A

See all OMEGA-3-ACID ETHYL ESTERS clinical trials

Pharmacology for OMEGA-3-ACID ETHYL ESTERS
Drug ClassOmega-3 Fatty Acid
Paragraph IV (Patent) Challenges for OMEGA-3-ACID ETHYL ESTERS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOVAZA Capsules omega-3-acid ethyl esters 1 g 021654 3 2008-11-10

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
Amneal Pharms OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 204940-001 Nov 27, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glw OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 212504-001 Aug 19, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 206455-001 Aug 7, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 091018-001 Jun 24, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 215458-001 Nov 15, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 210834-001 Jan 9, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 090973-001 Sep 30, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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