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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
Formulation / Manufacturing:see details

Pharmacology for Tradename: SIMCOR

Clinical Trials for: SIMCOR

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>
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, 2010RXYes6,080,428<disabled><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
7,011,848Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor<disabled in preview>
6,129,930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night<disabled in preview>
6,746,691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics<disabled in preview>
6,676,967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia<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
Spain2234100Jun 16, 2005
European Patent Office0643965May 08, 2013
European Patent Office0999844May 17, 2000
Brazil9815454Oct 23, 2001
Austria289197Mar 15, 2005
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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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