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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 drug master file entries for this compound. Ten 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

Pharmacology for Tradename: ZETIA

Clinical Trials for: ZETIA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYesRE42461*PED<disabled> <disabled>
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYes7,030,106*PED<disabled>Y<disabled>
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYesRE37721*PED<disabled> <disabled>
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Expired Patents for Tradename: ZETIA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 20025,767,115<disabled>
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 20025,846,966*PED<disabled>
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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<disabled in preview>
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors<disabled in preview>
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles<disabled in preview>
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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
Norway20033355<disabled in preview>
Hungary230253<disabled in preview>
Czech Republic20031662<disabled in preview>
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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
/2005Austria<disabled>PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
2005 00003Denmark<disabled>
0132Netherlands<disabled>300132, 20140914, EXPIRES: 20171016
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