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Julphar
US Department of Justice
Cantor Fitzgerald
Colorcon
UBS
Express Scripts
Moodys
Federal Trade Commission
Covington

Generated: December 13, 2018

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

This drug has one hundred and sixty-one 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
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.

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, (5Z,8Z,11Z,14Z,17Z)-(9CI)
5,8,11,14,17-Eicosapentaenoic acid, (all-Z)-(8CI)
5,8,11,14,17-Eicosapentaenoic acid, ethyl ester, (all-Z)-
5Z,8Z,11Z,14Z,17Z-Eicosapentaenoic acid, ethyl ester
6GC8A4PAYH
73310-10-8
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
D0G2MW
D0LW5J
D0Q8BT
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 (TN)
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 eicosapent
ethyl eicosapentaenoate
Ethyl eicosapentaenoic acid
Ethyl EPA
Ethyl ester(all-Z)-5,8,11,14,17-Eicosapentaenoic acid
ethyl icosapentaenoate
ethyl icosapentate
ETHYL ICOSAPENTATE (Benazolin-Ethyl)
Ethyl icosapentate (JP17)
Ethyl icosapentate [JAN]
Ethyl icosapentate, JAN
ethyl-eicosapent
ethyl-eicosapentaenoic acid
ethyl-EPA
GTPL7441
HMS2094K19
HY-B0747
ICOSAPENT ETHYL
Icosapent ethyl (USAN)
Icosapent ethyl [USAN]
icosapentate
LMFA07010877
LS-63776
MFCD00673476
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)
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for VASCEPA

International Patents for VASCEPA

Country Document Number Estimated Expiration
United Kingdom 9901809 ➤ Try a Free Trial
Singapore 175389 ➤ Try a Free Trial
Denmark 2395991 ➤ Try a Free Trial
Lithuania 2424356 ➤ Try a Free Trial
Russian Federation 2013154780 ➤ Try a Free Trial
China 104042617 ➤ Try a Free Trial
Turkey 200504156 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for VASCEPA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 Belgium ➤ Try a Free 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:
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
QuintilesIMS
Cerilliant
US Army
Accenture
Citi
Harvard Business School
Chubb
Medtronic

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