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Details for Generic Name: niacin

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Niacin is the generic ingredient in eight branded drugs marketed by Medpointe Pharm Hlc, Barr, Lupin Ltd, Sun Pharma Global, Abbvie, Everylife, Halsey, Hikma Pharms Llc, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Upsher Smith, Sanofi Aventis Us, and Intl Minerals, and is included in twenty-six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are twelve drug master file entries for niacin. Nine suppliers are listed for this compound.

Summary for Generic Name: niacin

Tradenames:8
Patents:2
Applicants:19
NDAs:26
Drug Master File Entries: see list12
Suppliers / Packaging: see list38
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: niacin

Ingredient-typeNicotinic Acids
Drug ClassNicotinic Acid

Clinical Trials for: niacin

Niacin on Immune Activation : a Proof-of-concept Study
Status: Active, not recruiting Condition: HIV

Biosynthesis of PGD2 in Vivo
Status: Completed Condition: Healthy Volunteer

Short-term Effect of Extended-release Niacin on Endothelial Function.
Status: Completed Condition: Hypoalphalipoproteinemia

Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis
Status: Completed Condition: Healthy Volunteers

Effect of Niacin in the Lipoprotein (a) Concentration
Status: Completed Condition: Hypercholesterolemia

Niacin/Laropiprant and Endothelial Function
Status: Completed Condition: Coronary Heart Disease

Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)
Status: Completed Condition: Hypercholesterolemia; Hyperlipidemia

Niacin, N-3 Fatty Acids and Insulin Resistance
Status: Completed Condition: Metabolic Syndrome; Hypertriglyceridemia

Assessment Of Vascular Health After Niacin Therapy (AVANT)
Status: Completed Condition: Coronary Artery Disease; Carotid Artery Disease; Peripheral Artery Disease

SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia
Status: Completed Condition: Dyslipidemia

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients
Status: Recruiting Condition: Chronic Renal Failure; Hemodialysis

The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study
Status: Active, not recruiting Condition: Healthy Volunteers

Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
Status: Completed Condition: Ischemic Stroke

ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART
Status: Terminated Condition: HIV; Atherosclerosis

A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Status: Completed Condition: Healthy Subjects; Dyslipidaemias

Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)
Status: Withdrawn Condition: Dyslipidemia

Niacin and Endothelial Function in Early CKD
Status: Completed Condition: Chronic Kidney Disease

A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)
Status: Completed Condition: Hypercholesterolemia

Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)
Status: Completed Condition: Diabetes Mellitus Type 2

Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels
Status: Completed Condition: HIV Infections; Dyslipidemia; Endothelial Dysfunction

Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Status: Completed Condition: Healthy

Evaluation of the Effect of NICOtinic Acid (Niacin) on Elevated Lipoprotein(a) Levels (NICOLa Study)
Status: Active, not recruiting Condition: Elevated Lipoprotein(a) Levels

Role of Prostaglandins on Niacin-Induced Flushing
Status: Completed Condition: Flushing

Olive Oil on Nampt and Its Relation With Postprandial Inflammation and Atherosclerosis in the Setting of Metabolic Syndrome.
Status: Active, not recruiting Condition: Metabolic Syndrome

Niacin Skin Flush Response in Patients With Schizophrenia
Status: Completed Condition: Schizophrenia

Effects of Niacin on Good Cholesterol in People With Peripheral Arterial Disease
Status: Terminated Condition: Peripheral Arterial Disease

Effects of Niacin Therapy on Lipoprotein Composition and Function
Status: Recruiting Condition: Cardiovascular Disease

Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions
Status: Active, not recruiting Condition: Central Retinal Vein Occlusion; Branch Retinal Vein Occlusion

A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Status: Completed Condition: Hyperlipidemia; Hypercholesterolemia

To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Status: Completed Condition: Hypercholesterolemia

Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Status: Completed Condition: Dyslipidemia

Plaque Inflammation and Dysfunctional HDL Cholesterol in Participants Receiving Niacin and Statins in the AIM-HIGH Study (The HDL Proteomics Study)
Status: Completed Condition: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Atherosclerosis; Myocardial Infarction

Nicotinamide Safety Study
Status: Recruiting Condition: Pregnancy Induced Hypertension; Superimposed Preeclampsia; Hypertension

A Study to Evaluate Efficacy and Safety of Extended-Release Niacin (+) Laropiprant (+) Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
Status: Terminated Condition: Primary Hypercholesterolemia; Dyslipidemia

Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment
Status: Completed Condition: Type 2 Diabetes Mellitus; Dyslipidemia

Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
Status: Terminated Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia

Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
Status: Terminated Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia

Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)
Status: Completed Condition: Coronary Disease; Hypolipoproteinemia

A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(COMPLETED)
Status: Completed Condition: Type 2 Diabetes Mellitus

Niacin to Improve Blood Flow in People With Sickle Cell Disease
Status: Completed Condition: Sickle Cell Disease

Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease
Status: Terminated Condition: Coronary Artery Disease; Dyslipidemias

A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
Status: Terminated Condition: Hypercholesterolemia, Familial; Heterozygous Familial Hypercholesterolemia

Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia
Status: Recruiting Condition: Dyslipidemia

Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
Status: Terminated Condition: Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemia

Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
Status: Completed Condition: Carotid Atherosclerosis

Niacin Plus Statin to Prevent Vascular Events
Status: Terminated Condition: Cardiovascular Diseases; Heart Diseases; Cerebrovascular Accident; Coronary Disease; Atherosclerosis; Myocardial Infarction

Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
Status: Completed Condition: Cardiovascular Diseases

Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia
Status: Terminated Condition: Hyperlipoproteinemia; Metabolic Syndrome

The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker
Status: Not yet recruiting Condition: Hypercholesterolemia

Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Status: Completed Condition: Opioid Abuse

Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis
Status: Active, not recruiting Condition: Aortocoronary Saphenous Vein Bypass Graft Atherosclerosis; Intermediate Saphenous Vein Graft Lesions

Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
Status: Completed Condition: Metabolic Syndrome X; Insulin Resistance

Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease
Status: Active, not recruiting Condition: Polycystic Kidney Disease

Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
Status: Completed Condition: HIV-1 Infection

Effect of MK0524A on Flushing Caused by Niacin (0524A-056)
Status: Completed Condition: Flushing

The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)
Status: Completed Condition: Metabolic Syndrome

Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia
Status: Completed Condition: Cardiovascular Diseases; Heart Diseases; HIV Infections; Hyperlipidemia; Hypertriglyceridemia; Insulin Resistance; Atherosclerosis

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

Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
Status: Completed Condition: Cardiovascular Disease; Peripheral Arterial Disease; Diabetes Mellitus; Coronary Heart Disease

A Study to Evaluate the Use of the Drug Combination Vorinostat, Niacinamide, and Etoposide in Patients With Lymphoid Malignancies That Have Reoccurred
Status: Active, not recruiting Condition: Hodgkin's Disease; Non-Hodgkin's Lymphoma

Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
Status: Completed Condition: Hypercholesterolemia

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

Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
Status: Completed Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia

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

Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
Status: Completed Condition: Insulin Sensitivity; Lipoproteins Metabolism; Non Esterified Fatty Acid Kinetics; Lipid Profile

Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis
Status: Terminated Condition: Atherosclerosis

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

MK0524B Bioequivalence Study (0524B-070)
Status: Completed Condition: Dyslipidemia

Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
Status: Completed Condition: Dyslipidemia

The Impact of Tredaptive on Flow-Mediated Dilation in Cardiac Patients
Status: Terminated Condition: Coronary Artery Disease; Dyslipidemia

Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Status: Completed Condition: Pain

Effects of Niacin On Fatty Acid Trapping
Status: Recruiting Condition: Dyslipidemia

To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
Status: Active, not recruiting Condition: Retinal Vein Occlusion

Anticancer Activity of Nicotinamide on Lung Cancer
Status: Recruiting Condition: Non-Small-Cell Lung Carcinoma

Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST
Status: Completed Condition: Hypercholesterolemia

The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Status: Completed Condition: Hyperphosphatemia

The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
Status: Recruiting Condition: Chronic Kidney Disease

Alternative Options to Minimize Niacin-Induced Flushing
Status: Completed Condition: Hypercholesterolemia; Flushing

MK0524A Bioequivalence Study (0524A-059)
Status: Completed Condition: Dyslipidemia

Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
Status: Recruiting Condition: Obesity; Short Stature; Growth Hormone Deficiency

Obesity and Nonalcoholic Fatty Liver Disease
Status: Completed Condition: Non-Alcoholic Fatty Liver Disease

Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)
Status: Recruiting Condition: Coronary Artery Disease

Effect of Nicotinic Acid on Adipose Tissue Inflammation in Obese Subjects
Status: Completed Condition: Obesity

Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
Status: Completed Condition: Polycystic Ovary Syndrome

Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation
Status: Completed Condition: Hyperpigmentation

Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)
Status: Completed Condition: Hypercholesterolemia; Hyperlipidemia

Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)
Status: Completed Condition: Dyslipidemia

Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)
Status: Completed Condition: Flushing

Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
Status: Completed Condition: Dyslipidemia; Coronary Heart Disease; Atherosclerosis; Stroke; Diabetes

Effect of an Investigational Compound on Tolerability of Extended Release Niacin
Status: Completed Condition: Hypercholesteremia; Hyperlipidemia

Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Status: Recruiting Condition: Coronary Artery Disease; Carotid Artery Diseases; Atherosclerosis

MK0524A Clinical Efficacy Study
Status: Completed Condition: Hypercholesterolemia

Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy
Status: Completed Condition: Dyslipidemia; Hyperlipidemia; Hyperglycemia

Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
Status: Completed Condition: HIV Infections; Hypercholesterolemia; Hypertriglyceridemia; Diabetes Mellitus

Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
Status: Terminated Condition: Dialysis; Cardiovascular Disease; Atherosclerosis; Inflammation

Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Status: Completed Condition: Peripheral Arterial Disease

Effect of Nicotinamide in Friedreich's Ataxia
Status: Recruiting Condition: Neurodegenerative Disorders

A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
Status: Completed Condition: Progressive Supranuclear Palsy

Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)
Status: Terminated Condition: Hypercholesterolemia; Mixed Dyslipidemia

Pioglitazone Vs Placebo in Combination With Niacin Extended Release on Low HDL
Status: Recruiting Condition: Metabolic Syndrome

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;ORAL022078-004Jul 28, 2010RXYes6,469,035<disabled><disabled>
Watson Labs
NIACIN
niacin
TABLET;ORAL083305-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-005Jul 28, 2010RXYes6,469,035<disabled><disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-002Feb 15, 2008RXYes6,469,035<disabled><disabled>
Abbvie
SIMCOR
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078-005Jul 28, 2010RXYes6,080,428<disabled><disabled>
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International Patent Family for Ingredient: niacin

Country Document Number Publication Date
European Patent Office0966284Dec 29, 1999
Brazil9815454Oct 23, 2001
World Intellectual Property Organization (WIPO)9906052Feb 11, 1999
Finland991895Sep 22, 1999
Norway994275Sep 02, 1999
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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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