You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Merck
Harvard Business School
Medtronic
Moodys

Last Updated: February 22, 2024

Icosapent ethyl - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Strides Pharma, Teva Pharms Usa, Zydus, and Amarin Pharms, and is included in nine NDAs. There are seventy patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Icosapent ethyl has three hundred and forty-seven patent family members in forty-five countries.

There are six drug master file entries for icosapent ethyl. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for icosapent ethyl

See drug prices for icosapent ethyl

Recent Clinical Trials for icosapent ethyl

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
HLS Therapeutics, IncPhase 4
Unity Health TorontoPhase 4

See all icosapent ethyl clinical trials

Generic filers with tentative approvals for ICOSAPENT ETHYL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial500MGCAPSULE;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 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
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for icosapent ethyl

Country Patent Number Title Estimated Expiration
Hong Kong 1256168 在相伴他汀類療法的對象中降低甘油三酯、沒有增加LDL-C水平的組合物和方法 (COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES WITHOUT RAISING LDL-C LEVELS IN A SUBJECT ON CONCOMITANT STATIN THERAPY) ⤷  Try a Trial
South Korea 20120000109 STABLE PHARMACEUTICAL COMPOSITION AND METHODS OF USING SAME ⤷  Try a Trial
Portugal 2443246 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for icosapent ethyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2443246 PA2021522 Lithuania ⤷  Try a Trial PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326
0253738 96C0009 Belgium ⤷  Try a 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:
2022495 21C1045 France ⤷  Try a Trial PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
>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:

Baxter
Medtronic
Harvard Business School
McKinsey
Dow
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.