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Last Updated: May 14, 2021

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ICOSAPENT ETHYL Drug Profile

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

Icosapent Ethyl is a drug marketed by Dr Reddys, Hikma, and Teva Pharms Usa. and is included in three NDAs.

The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There are twelve drug master file entries for this compound. Three 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

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SponsorPhase
University of Western Ontario, CanadaPhase 4
HLS Therapeutics, IncPhase 4
Canadian Medical and Surgical Knowledge Translation Research GroupPhase 4

See all ICOSAPENT ETHYL clinical trials

Paragraph IV (Patent) Challenges for ICOSAPENT ETHYL
Tradename Dosage Ingredient NDA Submissiondate
VASCEPA CAPSULE;ORAL icosapent ethyl 202057 2017-08-29
VASCEPA CAPSULE;ORAL icosapent ethyl 202057 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
Dr Reddys ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209499-001 Aug 7, 2020 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms Usa ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209525-001 Sep 11, 2020 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Hikma ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209457-001 May 21, 2020 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms Usa ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209525-002 Sep 11, 2020 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Dow
McKinsey
Moodys
Boehringer Ingelheim

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