Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 20, 2019

DrugPatentWatch Database Preview

VASCEPA Drug Profile

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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 twenty-five patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-three patent family members in forty-one countries.

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

Drug patent expirations by year for VASCEPA
Drug Prices for VASCEPA

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Generic Entry Opportunity Date for VASCEPA
Generic Entry Date for VASCEPA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VASCEPA

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SponsorPhase
Harvard School of Public HealthPhase 2
Mingyang SongPhase 2
Amarin Pharma Inc.Phase 3

See all VASCEPA clinical trials

Recent Litigation for VASCEPA

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 VASCEPA litigation

Synonyms for VASCEPA
(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
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 (TN)
WE(22:5)
ZINC3785276

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 202057-002 Feb 16, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for VASCEPA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 500 mg ➤ Subscribe   Start Trial
➤ Subscribe Capsules 1 g ➤ Subscribe   Start Trial
➤ Subscribe Capsules 1 g ➤ Subscribe   Start Trial

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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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 verifification 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.