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Last Updated: December 12, 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
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  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 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  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 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  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

International Patents for icosapent ethyl

Country Patent Number Title Estimated Expiration
European Patent Office 3278665 COMPOSITION PHARMACEUTIQUE STABLE ET PROCÉDÉS D'UTILISATION ASSOCIÉS (STABLE PHARMACEUTICAL COMPOSITION AND METHODS OF USING SAME) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2010147994 ⤷  Sign Up
Portugal 3815684 ⤷  Sign Up
Cyprus 1122628 ⤷  Sign Up
Spain 2426132 ⤷  Sign Up
Poland 3318255 ⤷  Sign Up
Eurasian Patent Organization 202190859 СПОСОБЫ СНИЖЕНИЯ РИСКА СЕРДЕЧНО-СОСУДИСТЫХ СОБЫТИЙ У СУБЪЕКТА ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for icosapent ethyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2443246 SPC/GB21/056 United Kingdom ⤷  Sign Up PRODUCT NAME: ICOSAPENT ETHYL; REGISTERED: UK EU/1/20/1524(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329
2443246 CA 2021 00036 Denmark ⤷  Sign Up PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
2443246 2021C/538 Belgium ⤷  Sign Up PRODUCT NAME: VAZKEPA - ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
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 21C1046 France ⤷  Sign Up PRODUCT NAME: ICOSAPENT ETHYL; NAT. REGISTRATION NO/DATE: EU/1/20/1524 20210329; FIRST REGISTRATION: - EU/1/20/1524 20210329
2022495 21C1045 France ⤷  Sign Up PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246 122021000056 Germany ⤷  Sign Up PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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