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Last Updated: November 21, 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
Canadian Medical and Surgical Knowledge Translation Research GroupPhase 4
St. Michael's Hospital, TorontoPhase 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 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 217844-002 Sep 22, 2023 AB RX No 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 202057-002 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

International Patents for icosapent ethyl

Country Patent Number Title Estimated Expiration
Canada 2772378 COMPOSITIONS ET PROCEDES POUR ABAISSER LES TRIGLYCERIDES SANS ELEVER LES TAUX DE LDL-C CHEZ UN SUJET SOUMIS A UNE THERAPIE CONCOMITANTE AUX STATINES (COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES WITHOUT RAISING LDL-C LEVELS IN A SUBJECT ON CONCOMITANT STATIN THERAPY) ⤷  Sign Up
Denmark 3363433 ⤷  Sign Up
Japan 2018184463 スタチン療法中の患者における心血管系イベントの危険性を減少させる方法 (METHODS FOR REDUCING RISK OF CARDIOVASCULAR EVENT IN PATIENT ON STATIN THERAPY) ⤷  Sign Up
Denmark 2596786 ⤷  Sign Up
Denmark 2443246 ⤷  Sign Up
Slovenia 3037089 ⤷  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 39/2021 Austria ⤷  Sign Up PRODUCT NAME: ICOSAPENT-ETHYL (= EICOSAPENTAENSAEUREETHYLESTER,; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246 132021000000156 Italy ⤷  Sign Up PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329
2443246 122021000056 Germany ⤷  Sign Up PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326
2022495 122021000058 Germany ⤷  Sign Up PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246 301137 Netherlands ⤷  Sign Up PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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