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Argus Health
US Army
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Generated: August 17, 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. Eighteen 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, 2002ABRXYesYes► Subscribe► SubscribeY► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► SubscribeY► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002ABRXYesYes► Subscribe► 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, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► 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
7,071,181Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors► Subscribe
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles► Subscribe
5,631,365 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents► Subscribe
6,982,251Substituted 2-azetidinones useful as hypocholesterolemic agents► Subscribe
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors► 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
Hong Kong1063607► Subscribe
Russian Federation2008144912► Subscribe
Slovakia9502003► Subscribe
China100475829► Subscribe
Slovenia1363668► 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
C001/2005Ireland► SubscribeSPC001/2005: 20050803, EXPIRES: 20190401
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
2005 00003Denmark► Subscribe
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
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
Covington
Novartis
Express Scripts
Healthtrust
Colorcon
UBS
Chubb
Daiichi Sankyo
Citi

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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