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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 nine 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. 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 list9
Drug Prices: :see details

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, 2002RXYes7,030,106*PEDJul 25, 2022Y
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYesRE42461*PEDApr 25, 2017
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002RXYes7,612,058*PEDApr 30, 2026Y
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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
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles<disabled in preview>
7,056,906Combinations of hormone replacement therapy composition(s) and sterol absorption inhibitor(s) and treatments for vascular conditions in post-menopausal women<disabled in preview>
7,053,080Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors<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
Russian Federation2003126186<disabled in preview>
Japan4937836<disabled in preview>
Israel156359<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
C001/2005Ireland<disabled>SPC001/2005: 20050803, EXPIRES: 20190401
C/GB03/023United Kingdom<disabled>PRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: PL 19945/0001-0002 20021017; FIRST REGISTRATION: DE 54486.00.00, 54488.00.00, 54487.00.00, 54489.00.00 20021017
00688Netherlands<disabled>PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
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