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Last Updated: July 12, 2020

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VASCEPA Drug Profile


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When do Vascepa patents expire, and what generic alternatives are available?

Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are fifty-five patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and sixty-three patent family members in fifty countries.

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

US ANDA Litigation and Generic Entry Outlook for Vascepa

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

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Drug patent expirations by year for VASCEPA
Drug Prices for VASCEPA

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Recent Clinical Trials for VASCEPA

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SponsorPhase
Matinas BioPharma Nanotechnologies, Inc.Phase 2
Matinas Biopharma, IncPhase 2
MB Clinical Research and Consulting LLCPhase 2

See all VASCEPA clinical trials

Paragraph IV (Patent) Challenges for VASCEPA
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 VASCEPA

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   Start Trial   Start Trial   Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No   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 202057-001 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 RX Yes No   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
>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 VASCEPA

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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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
McKesson
Merck

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