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Profile for Tradename: ADVICOR

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Advicor 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 four Paragraph IV challenges.

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

The generic ingredient in ADVICOR is lovastatin; niacin. There are thirty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lovastatin; niacin profile page.

Summary for Tradename: ADVICOR

Patents:2
Applicants:1
NDAs:1
Suppliers: see list2
Formulation / Manufacturing:see details

Pharmacology for Tradename: ADVICOR

Clinical Trials for: ADVICOR

Phase II Trial - Breast Cancer Chemoprevention by Lovastatin
Status: Terminated Condition: Breast Cancer

The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
Status: Completed Condition: Intermittent Claudication; Peripheral Vascular Disease

Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication
Status: Completed Condition: Intermittent Claudication; Peripheral Vascular Disease

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
ADVICOR
lovastatin; niacin
TABLET, EXTENDED RELEASE;ORAL021249-004Apr 27, 2006RXYes6,469,035<disabled><disabled>
Abbvie
ADVICOR
lovastatin; niacin
TABLET, EXTENDED RELEASE;ORAL021249-003Dec 17, 2001RXYes6,080,428<disabled><disabled>
Abbvie
ADVICOR
lovastatin; niacin
TABLET, EXTENDED RELEASE;ORAL021249-002Dec 17, 2001RXYes6,469,035<disabled><disabled>
Abbvie
ADVICOR
lovastatin; niacin
TABLET, EXTENDED RELEASE;ORAL021249-004Apr 27, 2006RXYes6,080,428<disabled><disabled>
Abbvie
ADVICOR
lovastatin; niacin
TABLET, EXTENDED RELEASE;ORAL021249-003Dec 17, 2001RXYes6,469,035<disabled><disabled>
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Paragraph IV activity for: ADVICOR

Drugname Dosage Strength RLD Submissiondate
lovastatin and niacinExtended-release Tablets40 mg/1000 mgAdvicor11/19/2009
lovastatin and niacinExtended-release Tablets20 mg/750 mgAdvicor12/17/2008
lovastatin and niacinExtended-release Tablets20 mg/500 mgAdvicor9/22/2008
lovastatin and niacinExtended-release Tablets20 mg/1000 mgAdvicor5/22/2008

Non-Orange Book Patents for Tradename: ADVICOR

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
6,676,967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia<disabled in preview>
6,129,930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night<disabled in preview>
7,011,848Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor<disabled in preview>
7,998,506Nicotinic acid compositions for treating hyperlipidemia and related methods therefor<disabled in preview>
6,746,691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics<disabled in preview>
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International Patent Family for Tradename: ADVICOR

Country Document Number Publication Date
Norway20000406Mar 20, 2000
Finland991896Sep 22, 1999
Norway994275Sep 02, 1999
World Intellectual Property Organization (WIPO)9906052Apr 29, 1999
Canada2297756Apr 29, 2008
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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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