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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Boehringer Ingelheim
Medtronic
Daiichi Sankyo
Healthtrust
McKesson
Citi
Merck
Fish and Richardson

Generated: December 14, 2017

DrugPatentWatch Database Preview

ZETIA Drug Profile

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When do Zetia patents expire, and what generic alternatives are available?

Zetia is a drug marketed by Msd Intl Gmbh and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-four countries and twenty supplementary protection certificates in nine countries.

The generic ingredient in ZETIA is ezetimibe. There are twenty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.
Drug patent expirations by year for ZETIA

Pharmacology for ZETIA

Medical Subject Heading (MeSH) Categories for ZETIA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: ZETIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl GmbhZETIAezetimibeTABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ZETIA

Drugname Dosage Strength RLD Submissiondate
ezetimibeTablets10 mgZetia10/25/2006

Non-Orange Book Patents for Tradename: ZETIA

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
5,631,365 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles► Subscribe
5,767,115 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors► Subscribe
7,071,181Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors► Subscribe
7,053,080Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors► Subscribe
7,056,906Combinations of hormone replacement therapy composition(s) and sterol absorption inhibitor(s) and treatments for vascular conditions in post-menopausal women► Subscribe
6,982,251Substituted 2-azetidinones useful as hypocholesterolemic agents► Subscribe
6,864,385 Process for the preparation of 4-haloalkylnicotinonitriles► 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: ZETIA

Country Document Number Estimated Expiration
Germany69418613► Subscribe
Japan4351842► Subscribe
World Intellectual Property Organization (WIPO)02058733► Subscribe
Slovakia35596► Subscribe
Luxembourg91050► Subscribe
Austria362757► Subscribe
World Intellectual Property Organization (WIPO)02058685► Subscribe
Serbia51449► Subscribe
Poland368653► Subscribe
European Patent Office1810693► 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: ZETIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00688Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
2014 00050Denmark► SubscribePRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
2014 00048Denmark► SubscribePRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0720599/02Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
545Luxembourg► SubscribePRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
C/GB03/023United Kingdom► SubscribePRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: PL 19945/0001-0002 20021017; FIRST REGISTRATION: DE 54486.00.00, 54488.00.00, 54487.00.00, 54489.00.00 20021017
544Luxembourg► SubscribePRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0172Netherlands► Subscribe300172, 20140914, EXPIRES: 20190401
00132Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Accenture
US Army
Daiichi Sankyo
Dow
Medtronic
UBS
Argus Health
Harvard Business School
Chinese Patent Office

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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