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Serving 500+ biopharmaceutical companies globally:

Julphar
Teva
Chubb
Dow
Citi
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Deloitte
Chinese Patent Office
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Generated: June 25, 2017

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-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Icosapent ethyl has one hundred and four patent family members in forty countries.

There are eleven drug master file entries for icosapent ethyl. One supplier is listed for this compound.

Summary for Generic Name: icosapent ethyl

Tradenames:1
Patents:26
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers / Packagers: see list1
Bulk Api Vendors: see list21
Clinical Trials: see list111
Patent Applications: see list241
Drug Prices:see low prices
DailyMed Link:icosapent ethyl 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;ORAL202057-001Jul 26, 2012RXYesYes8,426,399► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-001Jul 26, 2012RXYesYes8,399,446► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-001Jul 26, 2012RXYesYes8,314,086► Subscribe ► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-001Jul 26, 2012RXYesYes► Subscribe► Subscribe
Amarin Pharms
VASCEPA
icosapent ethyl
CAPSULE;ORAL202057-001Jul 26, 2012RXYesYes8,501,225► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,454,994Stable pharmaceutical composition and methods of using same► Subscribe
8,642,077Stable pharmaceutical composition and methods of using same► Subscribe
8,663,662Stable pharmaceutical composition and methods of using same► Subscribe
6,384,077 Highly purified EPA for treatment of schizophrenia and related disorders► Subscribe
8,618,166Methods of treating mixed dyslipidemia► 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 Ingredient: icosapent ethyl

Country Document Number Estimated Expiration
South Korea20140007973► Subscribe
Yugoslavia54201► Subscribe
Russian Federation2013154780► Subscribe
Slovakia10392001► Subscribe
Spain2246825► 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: ICOSAPENT ETHYL

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:

Deloitte
US Army
Colorcon
Harvard Business School
Healthtrust
Teva
Daiichi Sankyo
Argus Health
Baxter
US Department of Justice

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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