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Last Updated: February 28, 2024

ICOSAPENT ETHYL - Generic Drug Details


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What are the generic drug sources for icosapent ethyl and what is the scope of patent protection?

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, and Amarin Pharms, and is included in nine NDAs. There are seventy 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 forty-seven patent family members in forty-five countries.

There are six drug master file entries for icosapent ethyl. Thirteen suppliers are listed for this compound. There is one tentative approval 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

Generic filers with tentative approvals for ICOSAPENT ETHYL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial500MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 217656-002 Apr 20, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes 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

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
Colombia 6491035 COMPOSICIONES Y MÉTODOS PARA DISMINUIR LOS TRIGLICÉRIDOS SIN ELEVAR LOS NIVELES DE LDL-C EN UN SUJETO EN TERAPIA CONCOMITANTE CON ESTATINA ⤷  Try a Trial
Russian Federation 2011148362 СТАБИЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ ⤷  Try a Trial
European Patent Office 3363433 PROCÉDÉS DE RÉDUCTION DU RISQUE D'UN ÉVÉNEMENT CARDIOVASCULAIRE CHEZ UN SUJET SUR UNE THÉRAPIE UTILISANT LA STATINE (METHODS OF REDUCING THE RISK OF A CARDIOVASCULAR EVENT IN A SUBJECT ON STATIN THERAPY) ⤷  Try a Trial
Morocco 60150 Procédés de réduction du risque d'événements cardiovasculaires chez un sujet ⤷  Try a Trial
Eurasian Patent Organization 201890380 СПОСОБЫ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО СОБЫТИЯ У СУБЪЕКТА, ПОЛУЧАЮЩЕГО ТЕРАПИЮ СТАТИНОМ ⤷  Try a Trial
Croatia P20210309 ⤷  Try a Trial
Cyprus 1123549 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ICOSAPENT ETHYL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2443246 21C1046 France ⤷  Try a Trial PRODUCT NAME: ICOSAPENT ETHYL; NAT. REGISTRATION NO/DATE: EU/1/20/1524 20210329; FIRST REGISTRATION: - EU/1/20/1524 20210329
2443246 122021000056 Germany ⤷  Try a Trial PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246 C20210022 00395 Estonia ⤷  Try a Trial PRODUCT NAME: IKOSAPENTETUEUEL;REG NO/DATE: EU/1/20/1524 29.03.2021
2443246 301137 Netherlands ⤷  Try a Trial PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246 39/2021 Austria ⤷  Try a Trial PRODUCT NAME: ICOSAPENT-ETHYL (= EICOSAPENTAENSAEUREETHYLESTER,; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2022495 132021000000154 Italy ⤷  Try a Trial PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329
2443246 CR 2021 00036 Denmark ⤷  Try a Trial PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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