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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Colorcon
Julphar
Covington
US Army
Chubb
Dow
Queensland Health
Cipla

Generated: April 24, 2018

DrugPatentWatch Database Preview

Icosapent ethyl - Generic Drug Details

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What are the generic drug sources for icosapent ethyl and what is the scope of icosapent ethyl 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 sixty-one patent family members in forty-one countries.

There are eleven drug master file entries for icosapent ethyl. One supplier is listed for this compound.
Summary for icosapent ethyl
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, (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 (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
Vascepa (TN)
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 202057-002 Feb 16, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Non-Orange Book US Patents for icosapent ethyl

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,585,856 Stable pharmaceutical composition and methods of using same ➤ Sign Up
9,138,415 Stable pharmaceutical composition and methods of using same ➤ Sign Up
9,056,088 Pharmaceutical compositions comprising fatty acids ➤ Sign Up
9,855,237 Methods of treating mixed dyslipidemia ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for icosapent ethyl

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 Belgium ➤ Sign Up 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:

AstraZeneca
Cerilliant
Cantor Fitzgerald
Boehringer Ingelheim
Deloitte
Colorcon
Julphar
Daiichi Sankyo
Johnson and Johnson

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.