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Last Updated: December 13, 2024

Icosapent ethyl - Generic Drug Details


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What are the generic sources for icosapent ethyl and what is the scope of freedom to operate?

Icosapent ethyl is the generic ingredient in two branded drugs marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Strides Pharma, Teva Pharms Usa, Zydus Lifesciences, and Amarin Pharms, and is included in nine NDAs. There are sixty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Icosapent ethyl has three hundred and sixty-nine patent family members in forty-six countries.

There are six drug master file entries for icosapent ethyl. Fifteen suppliers are listed for this compound.

Drug Prices for icosapent ethyl

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Recent Clinical Trials for icosapent ethyl

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

SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
University of Western Ontario, CanadaPhase 4
HLS Therapeutics, IncPhase 4

See all icosapent ethyl clinical trials

Paragraph IV (Patent) Challenges for ICOSAPENT ETHYL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VASCEPA Capsules icosapent ethyl 500 mg 202057 1 2017-08-29
VASCEPA Capsules icosapent ethyl 1 g 202057 4 2016-07-26

US Patents and Regulatory Information for icosapent ethyl

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209525-002 Sep 11, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for icosapent ethyl

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amarin Pharmaceuticals Ireland Limited Vazkepa icosapent ethyl EMEA/H/C/005398
Indicated to reduce cardiovascular risk as an adjunct to statin therapy.
Authorised no no no 2021-03-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for icosapent ethyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2443246 C202130052 Spain ⤷  Sign Up PRODUCT NAME: ICOSAPENTO DE ETILO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1524; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1524; DATE OF FIRST AUTHORISATION IN EEA: 20210326
2443246 CR 2021 00036 Denmark ⤷  Sign Up PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
2443246 2021042 Norway ⤷  Sign Up PRODUCT NAME: IKOSAPENTETYL; REG. NO/DATE: EU/1/20/1524 20210408
2443246 21C1046 France ⤷  Sign Up PRODUCT NAME: ICOSAPENT ETHYL; NAT. REGISTRATION NO/DATE: EU/1/20/1524 20210329; FIRST REGISTRATION: - EU/1/20/1524 20210329
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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