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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

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, 2004RXNoRE42461*PED<disabled> <disabled>
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-004Jul 23, 2004RXYesRE42461*PED<disabled> <disabled>
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-002Jul 23, 2004RXNoRE37721*PED<disabled> <disabled>
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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;ORAL021687-004Jul 23, 20045,846,966*PED<disabled>
Msd Intl
VYTORIN
ezetimibe; simvastatin
TABLET;ORAL021687-003Jul 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
New Zealand274041<disabled in preview>
Denmark0720599<disabled in preview>
Australia7795294<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
C0040France<disabled>PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
C0028France<disabled>PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
/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
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