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Serving leading biopharmaceutical companies globally:

Healthtrust
Boehringer Ingelheim
Fish and Richardson
Daiichi Sankyo
Cipla
US Army
Federal Trade Commission
McKesson
Farmers Insurance
AstraZeneca

Generated: January 19, 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 sixteen 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

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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
8,613,945 Stable pharmaceutical composition and methods of using same ➤ Subscribe
9,060,983 Stable pharmaceutical composition and methods of using same ➤ Subscribe
6,384,077 Highly purified EPA for treatment of schizophrenia and related disorders ➤ Subscribe
8,618,166 Methods of treating mixed dyslipidemia ➤ Subscribe
8,703,185 Stable pharmaceutical composition and methods of using same ➤ Subscribe
9,585,856 Stable pharmaceutical composition and methods of using same ➤ Subscribe
9,072,715 Stable pharmaceutical composition and methods of using same ➤ Subscribe
8,324,195 Methods of treating hypertriglyceridemia ➤ Subscribe
8,680,144 Methods of treating mixed dyslipidemia ➤ Subscribe
9,138,415 Stable pharmaceutical composition and methods of using same ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for icosapent ethyl

Supplementary Protection Certificates for icosapent ethyl

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 Belgium ➤ Subscribe 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 leading biopharmaceutical companies globally:

US Department of Justice
Accenture
Queensland Health
McKesson
Cantor Fitzgerald
Fuji
Chinese Patent Office
Argus Health
QuintilesIMS

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.

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