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Profile for Tradename: ZETIA

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

The generic ingredient in ZETIA is ezetimibe. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the ezetimibe profile page.

Summary for Tradename: ZETIA

Patents:5
Applicants:1
NDAs:1
Suppliers: see list7
2013 Sales:$1,710,526,000

Pharmacology for Tradename: ZETIA

Clinical Trials for: ZETIA

CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers
Status: Recruiting Condition: Healthy

Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)
Status: Completed Condition: Hypercholesterolemia

Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects
Status: Completed Condition: Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression

Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
Status: Completed Condition: Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression

Study of Heart and Renal Protection
Status: Completed Condition: Kidney Disease, Chronic

Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia
Status: Completed Condition: Dyslipidemia

Effect of Simvastatin and Ezetimibe on Lipid and Inflammation
Status: Completed Condition: Prediabetes; Hypercholesterolemia; Inflammation; Cardiovascular Risk

Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Status: Completed Condition: Pharmacokinetics; Drug Interactions; Pharmacodynamics; Intestinal Transporter Expression

A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)
Status: Completed Condition: Hypercholesterolemia; Familial Hypercholesterolemia; Homozygous Sitosterolemia

A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245)
Status: Completed Condition: Hypercholesterolemia; Familial Hypercholesterolemia; Homozygous Sitosterolemia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;ORAL021445Oct 25, 2002RXYesRE42461*PED<disabled><disabled>
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445Oct 25, 2002RXYes5,846,966*PED<disabled>Y<disabled>
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445Oct 25, 2002RXYes<disabled><disabled>
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445Oct 25, 2002RXYesRE37721*PED<disabled><disabled>
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445Oct 25, 2002RXYes7,612,058*PED<disabled>Y<disabled>
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Paragraph IV activity for: ZETIA

Drugname Dosage Strength RLD Submissiondate
ezetimibeTablets10 mgZetia10/25/2006
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