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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Accenture
Julphar
Fish and Richardson
Citi
Deloitte
Daiichi Sankyo
QuintilesIMS
Federal Trade Commission
Cipla

Generated: June 22, 2017

DrugPatentWatch Database Preview

ZETIA Drug Profile

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What is the patent landscape for Zetia, and what generic Zetia 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 two hundred and eighty-one patent family members in forty-four countries.

The generic ingredient in ZETIA is ezetimibe. There are twenty-four drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.

Summary for Tradename: ZETIA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list7
Bulk Api Vendors: see list60
Clinical Trials: see list23
Patent Applications: see list3,897
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZETIA at DailyMed

Pharmacology for Tradename: ZETIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYes7,030,106*PED► SubscribeY► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYesRE42461*PED► Subscribe ► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYes7,612,058*PED► SubscribeY► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYesRE37721*PED► Subscribe ► Subscribe
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Expired Patents for Tradename: ZETIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RE42461*PED► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 20025,767,115► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RE37721*PED► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 20025,846,966*PED► Subscribe
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Paragraph IV activity 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
7,053,080Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors► Subscribe
7,071,181Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors► Subscribe
5,631,365 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles► 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
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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
Slovenia1593670► Subscribe
Norway20041598► Subscribe
Australia2002241956► Subscribe
Brazil1100159► Subscribe
European Patent Office1345906► 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
160Luxembourg► Subscribe91160, EXPIRES: 20190914
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
0172Netherlands► Subscribe300172, 20140914, EXPIRES: 20190401
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
0132Netherlands► Subscribe300132, 20140914, EXPIRES: 20171016
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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
Queensland Health
Chubb
Teva
Accenture
US Department of Justice
Julphar
Cerilliant
Farmers Insurance
McKinsey

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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