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Details for Generic Name: niacin; simvastatin

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Niacin; simvastatin is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are two patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-nine patent family members in ten countries.

There are twelve drug master file entries for niacin; simvastatin. Two suppliers are listed for this compound.

Summary for Generic Name: niacin; simvastatin

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list12
Suppliers / Packaging: see list14
Formulation / Manufacturing:see details

Pharmacology for Ingredient: niacin; simvastatin

Clinical Trials for: niacin; simvastatin

To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Status: Completed Condition: Hypercholesterolemia

MK0524B Bioequivalence Study (0524B-070)
Status: Completed Condition: Dyslipidemia

Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
Status: Terminated Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia

A Study to Evaluate Efficacy and Safety of Extended-Release Niacin (+) Laropiprant (+) Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
Status: Terminated Condition: Primary Hypercholesterolemia; Dyslipidemia

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

Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
Status: Completed Condition: Hypercholesterolemia

An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)
Status: Completed Condition: Hyperlipidemia; Mixed Dyslipidemia

Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
Status: Completed Condition: Hypercholesterolemia

Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
Status: Completed Condition: Cardiovascular Disease; Peripheral Arterial Disease; Diabetes Mellitus; Coronary Heart Disease

Plaque Inflammation and Dysfunctional HDL Cholesterol in Participants Receiving Niacin and Statins in the AIM-HIGH Study (The HDL Proteomics Study)
Status: Completed Condition: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Atherosclerosis; Myocardial Infarction

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-005Jul 28, 2010RXYes6,469,035<disabled><disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-003Feb 15, 2008RXYes6,469,035<disabled><disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-004Jul 28, 2010RXYes6,469,035<disabled><disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-005Jul 28, 2010RXYes6,080,428<disabled><disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-003Feb 15, 2008RXYes6,080,428<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: niacin; simvastatin

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
6,746,691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics<disabled in preview>
6,129,930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night<disabled in preview>
6,818,229 Intermediate release nicotinic acid compositions for treating hyperlipidemia<disabled in preview>
6,676,967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia<disabled in preview>
6,406,715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles<disabled in preview>
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International Patent Family for Ingredient: niacin; simvastatin

Country Document Number Publication Date
Norway994275Oct 11, 1999
Canada2591710Sep 11, 1998
Norway994248Sep 02, 1999
World Intellectual Property Organization (WIPO)9839002Sep 11, 1998
Australia6454598Sep 22, 1998
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ISSN: 2162-2639

Preferred citation:

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

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