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Last Updated: November 30, 2022

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, Dr Reddys, Hikma, Teva Pharms Usa, and Amarin Pharms, and is included in five NDAs. There are sixty-nine 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 twenty-three patent family members in forty-four countries.

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

Drug Prices for icosapent ethyl

See drug prices for icosapent ethyl

Recent Clinical Trials for icosapent ethyl

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

SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
Canadian Medical and Surgical Knowledge Translation Research GroupPhase 4
St. Michael's Hospital, TorontoPhase 4

See all icosapent ethyl clinical trials

Generic filers with tentative approvals for ICOSAPENT ETHYL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1GMCAPSULE;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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 icosapent ethyl

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
Denmark 3278665 See Plans and Pricing
European Patent Office 3750536 PROCÉDÉS DE RÉDUCTION DU RISQUE D'ÉVÉNEMENTS CARDIOVASCULAIRES CHEZ UN SUJET (METHODS OF REDUCING THE RISK OF CARDIOVASCULAR EVENTS IN A SUBJECT) See Plans and Pricing
European Patent Office 3616694 ESTER ETHYLIQUE DE L'ACIDE EICOSAPENTAENOIQUE POUR LE TRAITEMENT DE L'HYPERTRIGLYCÉRIDÉMIE (EICOSAPENTAENOIC ACID ETHYL ESTER FOR TREATING HYPERTRIGLYCERIDEMIA) See Plans and Pricing
South Korea 20140144232 COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES WITHOUT RAISING LDL-C LEVELS IN A SUBJECT ON CONCOMITANT STATIN THERAPY See Plans and Pricing
Australia 2010241567 Pharmaceutical compositions comprising EPA and a cardiovascular agent and methods of using the same See Plans and Pricing
New Zealand 771180 Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same See Plans and Pricing
Lithuania 3318255 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for icosapent ethyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2022495 C202130051 Spain See Plans and Pricing 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 122021000056 Germany See Plans and Pricing PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246 301137 Netherlands See Plans and Pricing PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246 2021C/538 Belgium See Plans and Pricing PRODUCT NAME: VAZKEPA - ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2443246 LUC00226 Luxembourg See Plans and Pricing PRODUCT NAME: ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2022495 21C1045 France See Plans and Pricing PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246 C202130052 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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