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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 two patents protecting this drug and eight Paragraph IV challenges.

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

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

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list14

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

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

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

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

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;ORAL022078-002Feb 15, 2008RXYes6,469,035<disabled> <disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-003Feb 15, 2008RXYes6,080,428<disabled> <disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-005Jul 28, 2010RXYes6,080,428<disabled> <disabled>
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Expired Patents for Tradename: SIMCOR

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-005Jul 28, 20106,746,691<disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-004Jul 28, 20106,818,229<disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-002Feb 15, 20086,746,691<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

Non-Orange Book Patents for Tradename: SIMCOR

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
6,129,930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night<disabled in preview>
7,998,506Nicotinic acid compositions for treating hyperlipidemia and related methods therefor<disabled in preview>
6,818,229 Intermediate release nicotinic acid compositions for treating hyperlipidemia<disabled in preview>
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International Patent Family for Tradename: SIMCOR

Country Document Number Publication Date
Australia8605298Feb 22, 1999
European Patent Office0999844May 17, 2000
Norway994275Oct 11, 1999
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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