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Serving 500+ biopharmaceutical companies globally:

Baxter
Harvard Business School
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US Department of Justice
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Federal Trade Commission

Generated: September 23, 2017

DrugPatentWatch Database Preview

VASCEPA Drug Profile

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Which patents cover Vascepa, and what generic Vascepa 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 two Paragraph IV challenges.

This drug has one hundred and seven patent family members in forty countries.

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

Summary for Tradename: VASCEPA

Patents:25
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list21
Clinical Trials: see list5
Patent Applications: see list175
Drug Prices:see details
DailyMed Link:VASCEPA at DailyMed
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;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-002Feb 16, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-001Jul 26, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-001Jul 26, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for VASCEPA

Drugname Dosage Strength RLD Submissiondate
icosapent ethyl Capsules1 gVascepa7/26/2016
icosapent ethylCapsules1 gVascepa1/15/2013

Non-Orange Book Patents for Tradename: VASCEPA

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
8,709,475Stable pharmaceutical composition and methods of using same► Subscribe
8,618,166Methods of treating mixed dyslipidemia► Subscribe
9,060,982Stable pharmaceutical composition and methods of using same► Subscribe
9,585,856Stable pharmaceutical composition and methods of using same► Subscribe
6,384,077 Highly purified EPA for treatment of schizophrenia and related disorders► Subscribe
8,680,144Methods of treating mixed dyslipidemia► Subscribe
8,324,195Methods of treating hypertriglyceridemia► Subscribe
9,060,983Stable pharmaceutical composition and methods of using same► Subscribe
8,691,871Methods of treating mixed dyslipidemia► Subscribe
7,119,118Highly purified ethyl EPA and other EPA derivatives for treatment of huntington's disease► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VASCEPA

Country Document Number Estimated Expiration
Russian Federation2011148363► Subscribe
China104042617► Subscribe
CroatiaP20010558► Subscribe
South Korea101357438► Subscribe
South Korea20140007973► Subscribe
Hong Kong1039564► Subscribe
BrazilPI1011876► Subscribe
New Zealand624963► Subscribe
Australia3065700► Subscribe
MexicoPA01007662► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VASCEPA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009Belgium► SubscribePRODUCT 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:
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Dow
Chubb
UBS
Deloitte
Covington
Chinese Patent Office
Medtronic
AstraZeneca
Accenture

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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