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Last Updated: October 19, 2019

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Icosapent ethyl - Generic Drug Details

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What are the generic drug sources for icosapent ethyl and what is the scope of freedom to operate?

Icosapent ethyl is the generic ingredient in one branded drug marketed by Amarin Pharms and is included in one NDA. There are twenty-five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Icosapent ethyl has one hundred and thirty-three patent family members in forty-one countries.

There are twelve drug master file entries for icosapent ethyl. One supplier is listed for this compound.

Recent Clinical Trials for icosapent ethyl

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

SponsorPhase
Harvard School of Public HealthPhase 2
Mingyang SongPhase 2
Mochida Pharmaceutical Company, Ltd.Phase 3

See all icosapent ethyl clinical trials

Recent Litigation for icosapent ethyl

Identify potential future generic entrants

District Court Litigation
Case NameDate
Amarin Pharma, Inc. v. Dr. Reddy's Laboratories, Inc.2018-08-24
Amarin Pharma Inc. v. West-Ward Pharmaceuticals Corp2016-10-31
AMARIN PHARMA, INC. v. DR. REDDY'S LABORATORIES, INC.2014-04-30

See all icosapent ethyl litigation

Synonyms for icosapent ethyl
(5Z,8Z,11Z,14Z,17Z)-5,8,11,14,17-Eicosapentaenoic Acid Ethyl Ester
(5Z,8Z,11Z,14Z,17Z)-Eicosapentaenoic acid ethyl ester
(5Z,8Z,11Z,14Z,17Z)-Eicosapetaenoic acid ethyl ester
(all-Z)-5,8,11,14,17-Eicosapentaenoic acid ethyl ester
1606AH
5-8-11-14-17-all cis-eicosapentaenoic acid ethyl ester
5,8,11,14,17-Eicosapentaenoic acid, ethyl ester, (all-Z)-
5Z,8Z,11Z,14Z,17Z-Eicosapentaenoic acid, ethyl ester
6GC8A4PAYH
86227-47-6
AB01563352_01
AKOS025295847
all cis-5,8,11,14,17-Eicosapentaenoic Acid Ethyl Ester
all-cis-ethyl 5,8,11,14,17-icosapentaenoate
AMR 101
AMR-101
AMR101
AN-5630
C16184
C22H34O2
CCG-213714
CHEBI:80366
CHEBI:84883
CHEMBL2095209
cis-5,8,11,14,17-Eicosapentaenoic acid ethyl ester
cis-Eicosapentaenoic acid ethyl ester
CS-5304
D01892
DB08887
E-EPA
E0442
E0853
Eicosapentaenoic acid (ethyl ester)
Eicosapentaenoic acid ethyl ester
Eicosapentaenoic acid, ethyl ester
EICOSAPENTAENOICACIDETHYLESTER(EPAEE)(SG)
EPA ethyl ester
EPA-E
Epadel
Epadel S (TN)
Ethyl (5Z,8Z,11Z,14Z,17Z)-eicosa-5,8,11,14,17-pentaenoate
ethyl (5Z,8Z,11Z,14Z,17Z)-eicosapentaenoate
ethyl (5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenoate
ethyl (5Z,8Z,11Z,14Z,17Z)-icosapentaenoate
Ethyl (all cis)-5,8,11,14,17-icosapentaenoate
Ethyl all cis-5,8,11,14,17-Eicosapentaenoate
Ethyl all cis-5,8,11,14,17-Icosapentaenoate
ethyl all-cis-5,8,11,14,17-icosapentaenoate
Ethyl all-cis-5,8,11,14,17-icosapentaenoic acid
ethyl eicosapentaenoate
Ethyl eicosapentaenoic acid
Ethyl EPA
Ethyl ester(all-Z)-5,8,11,14,17-Eicosapentaenoic acid
ethyl icosapentaenoate
ethyl icosapentate
Ethyl icosapentate (JP17)
Ethyl icosapentate [JAN]
Ethyl icosapentate, JAN
ethyl-eicosapentaenoic acid
ethyl-EPA
GTPL7441
HMS2094K19
HY-B0747
Icosapent ethyl (USAN)
Icosapent ethyl [USAN]
icosapentate
LMFA07010877
LS-63776
MND 21
MolPort-006-393-913
NSC-759597
NSC759597
OMEGA-3-ACID ESTERS (EPA shown)
Pharmakon1600-01300030
SBI-0206684.P002
SCHEMBL123305
SR-05000002595
SR-05000002595-1
SSQPWTVBQMWLSZ-AAQCHOMXSA-N
Timnodonic acid ethyl ester
UNII-6GC8A4PAYH
UNII-D87YGH4Z0Q component SSQPWTVBQMWLSZ-AAQCHOMXSA-N
Vascepa
Vascepa (TN)
WE(22:5)
ZINC3785276

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 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 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
>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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Harvard Business School
Boehringer Ingelheim
AstraZeneca
Medtronic
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Johnson and Johnson

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