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Details for Generic Name: lovastatin; niacin

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Lovastatin; niacin 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 four 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 thirty-three drug master file entries for lovastatin; niacin. Two suppliers are listed for this compound.

Summary for Generic Name: lovastatin; niacin

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list33
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details

Pharmacology for Ingredient: lovastatin; niacin

Clinical Trials for: lovastatin; niacin

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

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

Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
Status: Completed Condition: Hyperlipidemia; Mixed Hyperlipidemia; Dyslipidemia

Familial Atherosclerosis Treatment Study
Status: Completed Condition: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia

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

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

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, 2001RXYes6,469,035<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;ORAL021249-002Dec 17, 2001RXYes6,080,428<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: lovastatin; niacin

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>
6,676,967 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>
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 Ingredient: lovastatin; niacin

Country Document Number Publication Date
Germany69829042Mar 24, 2005
Canada2574987Sep 11, 1998
Brazil9815454Oct 23, 2001
Norway20000406Jan 27, 2000
Spain2234100Jun 16, 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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