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Last Updated: January 26, 2021

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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 Dr Reddys, Hikma, Teva Pharms Usa, and Amarin Pharms, and is included in four NDAs. There are fifty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Icosapent ethyl has two hundred and ninety-one patent family members in fifty-one countries.

There are twelve drug master file entries for icosapent ethyl. Three suppliers are listed for this compound. There is one tentative approval 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
St. Michael's Hospital, TorontoPhase 4
University of Western Ontario, CanadaPhase 4
HLS Therapeutics, IncPhase 4

See all icosapent ethyl clinical trials

Generic filers with tentative approvals for ICOSAPENT ETHYL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1GMCAPSULE;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 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
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for icosapent ethyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0253738 96C0009 Belgium   Start Trial PRODUCT NAME: CONCENTRE A 85 % D'OMEGA POLYINSATURES; QUANTITE CORRESPONDANT A :; ESTERS ETHYLIQUES D'ACIDE EICOSAPENTAENOIQUE (EPA) ET D'ACIDE DOCOSAHEXAENOIQUE (DHA); ALPHA TOCOPHEROL; NAT. REGISTRATION NO/DATE: NL 20819 19951002; FIRST REGISTRATION:
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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