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ZETIA Drug Profile

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

This drug has two hundred and eighty 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. Eleven suppliers are listed for this compound. There are six tentative approvals 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 list8
Bulk Api Vendors: see list60
Clinical Trials: see list16
Patent Applications: see list4,361
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYesYes7,030,106*PED► subscribeY► subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYesYesRE42461*PED► subscribe ► subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYesYes7,612,058*PED► 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 Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 20025,767,115► 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
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles► subscribe
7,053,080Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors► 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
China1658903► subscribe
New Zealand525921► subscribe
Norway20033358► 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
00172Netherlands► subscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
160Luxembourg► subscribe91160, EXPIRES: 20190914
2005 00003Denmark► subscribe
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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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