➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Dow
McKesson
Colorcon
Mallinckrodt

Last Updated: October 20, 2021

DrugPatentWatch Database Preview

VASCEPA Drug Patent Profile


Email this page to a colleague

« Back to Dashboard

Which patents cover Vascepa, and what generic alternatives are available?

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

This drug has two hundred and ninety-three patent family members in forty-three countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Vascepa

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

  Free Forever Trial

Drug patent expirations by year for VASCEPA
Drug Prices for VASCEPA

See drug prices for VASCEPA

Recent Clinical Trials for VASCEPA

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 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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VASCEPA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for VASCEPA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0253738 96C0009 Belgium ⤷  Free Forever 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Dow
McKesson
Colorcon
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.