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Last Updated: March 29, 2024

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 patent protection?

Omega-3-acid ethyl esters is the generic ingredient in three branded drugs marketed by Woodward, 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, Zydus, and Osmotica Pharm Us, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for omega-3-acid ethyl esters. Twenty-two suppliers are listed for this compound.

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sohag UniversityPhase 2/Phase 3
Liaquat National Hospital & Medical CollegeN/A
Aga Khan University Hospital, PakistanN/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
Strides Pharma OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 203893-001 Sep 19, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Slayback Pharma Llc OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 211345-001 Dec 7, 2023 AB RX 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
Woodward LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 AB RX Yes Yes ⤷  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

Expired US Patents for omega-3-acid ethyl esters

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Woodward LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ⤷  Try a Trial ⤷  Try a Trial
Woodward LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ⤷  Try a Trial ⤷  Try a Trial
Woodward LOVAZA omega-3-acid ethyl esters CAPSULE;ORAL 021654-001 Nov 10, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.