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Profile for Tradename: VYTORIN

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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 three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in VYTORIN is ezetimibe; simvastatin. There are sixteen 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

Suppliers: see list5
2013 Sales:$858,576,000

Clinical Trials for: VYTORIN

Vytorin in the Treatment of Alopecia Areata
Status: Recruiting Condition: Alopecia Areata

Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)
Status: Completed Condition: Hypercholesterolemia; Hyperlipidemia

Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
Status: Not yet recruiting Condition: Metabolic Syndrome

Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
Status: Completed Condition: Type 1 Diabetes Mellitus; Dyslipidemia

Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
Status: Completed Condition: Hypercholesterolemia

Vytorin Reexamination Study (0653A-174)
Status: Completed Condition: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)(COMPLETED)
Status: Completed Condition: Hyperlipidemia

To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects
Status: Active, not recruiting Condition: Inflammation

A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
Status: Completed Condition: Hypercholesterolemia

A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406)
Status: Withdrawn Condition: Dyslipidemia

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl
ezetimibe; simvastatin
TABLET;ORAL021687Jul 23, 2004RXYesRE42461*PED<disabled><disabled>
Msd Intl
ezetimibe; simvastatin
TABLET;ORAL021687Jul 23, 2004RXNo5,846,966*PED<disabled>Y<disabled>
Msd Intl
ezetimibe; simvastatin
TABLET;ORAL021687Jul 23, 2004RXNo<disabled><disabled>
Msd Intl
ezetimibe; simvastatin
TABLET;ORAL021687Jul 23, 2004RXYesRE37721*PED<disabled><disabled>
Msd Intl
ezetimibe; simvastatin
TABLET;ORAL021687Jul 23, 2004RXYes<disabled><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
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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