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ZETIA Drug Profile

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Which patents cover Zetia, and what substitute generic drugs 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 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
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYesYesRE37721*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, 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
5,767,115 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
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
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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
European Patent Office1427409► Subscribe
Russian Federation2008144912► Subscribe
World Intellectual Property Organization (WIPO)02058732► Subscribe
Norway333968► Subscribe
MexicoPA03006727► 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
C/GB05/010United Kingdom► SubscribePRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
90018-0Sweden► SubscribePRODUCT NAME: EZETIMIB
160Luxembourg► Subscribe91160, EXPIRES: 20190914
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
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
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