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Last Updated: August 14, 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-eight 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 fifteen patent family members in forty-three countries.

There are six drug master file entries for icosapent ethyl. Five 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 202057-002 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 202057-001 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 202057-001 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
>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 202057-002 Feb 16, 2017 See Plans and Pricing See Plans and Pricing
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 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
Slovenia 2424356 See Plans and Pricing
Poland 2395991 See Plans and Pricing
Russian Federation 2505292 СПОСОБЫ ЛЕЧЕНИЯ ГИПЕРТРИГЛИЦЕРИДЕМИИ (METHODS OF TREATING HYPERTRIGLYCERIDEMIA) See Plans and Pricing
New Zealand 595852 Stable pharmaceutical composition comprising ethyl eicosapentaenoate See Plans and Pricing
Dominican Republic P2014000301 MÉTODOS PARA REDUCIR EL RIESGO DE UN EVENTO CARDIOVASCULAR EN UN SUJETO CON TERAPIA CON ESTATINA See Plans and Pricing
Russian Federation 2538691 СТАБИЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (STABLE PHARMACEUTICAL COMPOSITIONS AND METHODS FOR USING THEM) 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
2443246 301137 Netherlands See Plans and Pricing PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246 CA 2021 00036 Denmark See Plans and Pricing PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
2443246 PA2021522 Lithuania See Plans and Pricing PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326
2022495 122021000058 Germany See Plans and Pricing PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246 122021000056 Germany See Plans and Pricing PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246 132021000000156 Italy See Plans and Pricing PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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