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Last Updated: November 21, 2024

ICOSAPENT ETHYL Drug Patent Profile


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Which patents cover Icosapent Ethyl, and what generic alternatives are available?

Icosapent Ethyl is a drug marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Strides Pharma, Teva Pharms Usa, and Zydus Lifesciences. and is included in eight NDAs.

The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Icosapent Ethyl

A generic version of ICOSAPENT ETHYL was approved as icosapent ethyl by HIKMA on May 21st, 2020.

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Drug patent expirations by year for ICOSAPENT ETHYL
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
St. Michael's Hospital, TorontoPhase 4
University of Western Ontario, CanadaPhase 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
Apotex ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209437-001 Jun 30, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209457-002 Mar 8, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209499-001 Aug 7, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209525-002 Sep 11, 2020 AB RX No 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

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