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Profile for Tradename: SIMCOR

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Simcor is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug and eight Paragraph IV challenges.

The generic ingredient in SIMCOR is niacin; simvastatin. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the niacin; simvastatin profile page.

Summary for Tradename: SIMCOR

Suppliers: see list2

Pharmacology for Tradename: SIMCOR

Clinical Trials for: SIMCOR

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
Status: Recruiting Condition: Congenital Heart Disease; Heart Valve Disease

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

Effect of Simvastatin on Cardiac Function
Status: Completed Condition: Rheumatic Heart Disease; Congenital Heart Disease; Aneurysm; Heart Valve Disease

Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Status: Completed Condition: Hypertriglyceridemia

Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
Status: Completed Condition: Hypertriglyceridemia

A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event.
Status: Recruiting Condition: Cardiovascular Diseases

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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
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Jul 28, 2010RXYes6,080,428<disabled><disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,080,428<disabled><disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Jul 28, 2010RXYes6,129,930<disabled>Y<disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Jul 28, 2010RXYes6,746,691<disabled>Y<disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,818,229<disabled>Y<disabled>
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Paragraph IV activity for: SIMCOR

Drugname Dosage Strength RLD Submissiondate
niacin and simvastatinExtended-release Tablets1000 mg/40 mgSimcor2/4/2011
niacin and simvastatinExtended-release Tablets500 mg/40 mgSimcor2/9/2011
niacin and simvastatin (date correction)Extended-release Tablets750 mg/20 mgSimcor2/17/2010
niacin and simvastatinExtended-release Tablets750 mg/20 mgSimcor3/1/2010
niacin and simvastatinExtended-release Tablets500 mg/20 mgSimcor2/12/2010
niacin and simvastatinExtended-release Tablets750 mg/20 mgSimcor2/12/2010
niacin and simvastatinExtended-release Tablets500 mg/20 mgSimcor3/19/2010
niacin andsimvastatinExtended-release Tablets1000 mg/20 mgSimcor9/17/2009
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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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