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Serving leading biopharmaceutical companies globally:

US Army
Farmers Insurance
UBS
Chinese Patent Office
Teva
Daiichi Sankyo
McKesson
Moodys
Cantor Fitzgerald
Chubb

Generated: January 23, 2018

DrugPatentWatch Database Preview

VASCEPA Drug Profile

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Which patents cover Vascepa, 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 sixteen patent family members in forty-one 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 VASCEPA
International Patents:116
US Patents:25
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 24
Clinical Trials: 5
Patent Applications: 188
Drug Prices:see details
DailyMed Link:VASCEPA at DailyMed
Drug patent expirations by year for VASCEPA

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 ➤ 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 202057-002 Feb 16, 2017 RX Yes No ➤ 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 202057-002 Feb 16, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ 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 202057-002 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 Y ➤ Subscribe
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 RX Yes Yes ➤ 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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Paragraph IV (Patent) Challenges for VASCEPA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 500 mg ➤ Subscribe 8/29/2017
➤ Subscribe Capsules 1 g ➤ Subscribe 7/26/2016
➤ Subscribe Capsules 1 g ➤ Subscribe 1/15/2013

Non-Orange Book US Patents for 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
9,060,982 Stable pharmaceutical composition and methods of using same ➤ Subscribe
9,585,856 Stable pharmaceutical composition and methods of using same ➤ Subscribe
8,703,185 Stable pharmaceutical composition and methods of using same ➤ Subscribe
6,384,077 Highly purified EPA for treatment of schizophrenia and related disorders ➤ Subscribe
8,691,871 Methods of treating mixed dyslipidemia ➤ Subscribe
9,056,088 Pharmaceutical compositions comprising fatty acids ➤ Subscribe
9,138,415 Stable pharmaceutical composition and methods of using same ➤ Subscribe
8,613,945 Stable pharmaceutical composition and methods of using same ➤ Subscribe
8,663,662 Stable pharmaceutical composition and methods of using same ➤ Subscribe
9,060,983 Stable pharmaceutical composition and methods of using same ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for VASCEPA

Supplementary Protection Certificates for VASCEPA

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:

Deloitte
Julphar
Moodys
Federal Trade Commission
Cipla
Daiichi Sankyo
Fuji
McKinsey
Boehringer Ingelheim

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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