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VYTORIN Drug Profile

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Vytorin is a drug marketed by Msd Intl and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-eight patent family members in thirty countries.

The generic ingredient in VYTORIN is ezetimibe; simvastatin. There are twenty drug master file entries for this compound. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

Summary for Tradename: VYTORIN

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Formulation / Manufacturing:see details
Drug Prices: :see details

Clinical Trials for: VYTORIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 2004RXNoRE37721*PEDApr 25, 2017
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 2004RXYesRE37721*PEDApr 25, 2017
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004RXNoRE42461*PEDApr 25, 2017
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Expired Patents for Tradename: VYTORIN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 23, 20045,846,966*PED<disabled>
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-001Jul 23, 20044,444,784<disabled>
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 20044,444,784<disabled>
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Paragraph IV activity for: VYTORIN

Drugname Dosage Strength RLD Submissiondate
ezetimibe and simvastatinTablets10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mgVytorin7/27/2009

Non-Orange Book Patents for Tradename: VYTORIN

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
5,631,365 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>
5,767,115 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents<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: VYTORIN

Country Document Number Estimated Expiration
Germany10399001<disabled in preview>
Netherlands300172<disabled in preview>
Norway305902<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: VYTORIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2005 00003Denmark<disabled>
2014 00050Denmark<disabled>PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
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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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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