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Details for Generic Name: allopurinol

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Allopurinol is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Apotex Inc, Ipca Labs Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Puracap Pharm, Purepac Pharm, Sandoz, Sun Pharm Inds Inc, Superpharm, Vintage Pharms, Watson Labs, Abbott, Dr Reddys La, Prometheus Labs, Eurohlth Intl Sarl, and Mylan Institutional, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for allopurinol. Nine suppliers are listed for this compound.

Summary for Generic Name: allopurinol

Tradenames:5
Patents:0
Applicants:18
NDAs:29
Drug Master File Entries: see list21
Suppliers: see list9
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: allopurinol

Clinical Trials for: allopurinol

A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL
Status: Recruiting Condition: Acute Lymphoblastic Leukemia (ALL)

Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study
Status: Enrolling by invitation Condition: End Stage Renal Disease; Left Ventricular Hypertrophy

Does Allopurinol Reduce Thickening of the Left Ventricle of the Heart in Patient With Treated Hypertension?
Status: Recruiting Condition: Hypertension; Hypertrophy, Left Ventricular

Allopurinol for Mania: A Randomized Trial Administering Allopurinol vs. Placebo as add-on to Mood Stabilizers and/or Antipsychotics in Patients in a Bipolar Manic Episode
Status: Completed Condition: Mania

Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
Status: Completed Condition: Gout; Hyperuricemia

Allopurinol in Acute Coronary Syndrome
Status: Recruiting Condition: Chronic Stable Angina

Allopurinol in Acute Gout
Status: Withdrawn Condition: Gout

Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia
Status: Completed Condition: Schizophrenia; Schizoaffective Disorder

Allopurinol Combination Study
Status: Active, not recruiting Condition: Gout

The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study
Status: Terminated Condition: Blood Pressure; Gout

Antenatal Allopurinol During Fetal Hypoxia
Status: Active, not recruiting Condition: Fetal Hypoxia; Reperfusion Injury

Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced Hand-foot Syndrome
Status: Completed Condition: Hand-foot Syndrome

A Pilot Study of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes
Status: Terminated Condition: Diabetic Nephropathies

A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes
Status: Recruiting Condition: Diabetic Nephropathies; Coronary Artery Disease

Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
Status: Completed Condition: Hyperuricosuria; Kidney Stones

Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Comorbidities
Status: Recruiting Condition: Cardiovascular Disease

Allopurinol Outcome Study
Status: Completed Condition: Gout

Does Allopurinol Prolong a Treated, Acute Gout Flare?
Status: Completed Condition: Gout

Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout
Status: Completed Condition: Gout; Gout Acute

Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients
Status: Completed Condition: Inflammatory Bowel Disease

Allopurinol in Functional Impairment (ALFIE) Trial: 'Improving Muscle Strength'
Status: Enrolling by invitation Condition: Sarcopenia

Allopurinol Maintenance Study for Bipolar Disorder
Status: Completed Condition: Bipolar Disorder; Mania; Mixed Mania

Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
Status: Completed Condition: Moderate to Severe Gout; Hyperuricemia

Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout
Status: Completed Condition: Gout

Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
Status: Recruiting Condition: Patients With Grade II Ankle Sprain

Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
Status: Completed Condition: Gout

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients
Status: Completed Condition: Gout

Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
Status: Recruiting Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Blastic Phase Chronic Myelogenous Leukemia; Contiguous Stage II Adult Burkitt Lymphoma; de Novo Myelodysplastic Syndromes; Noncontiguous Stage II Adult Burkitt Lymphoma; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Stage I Adult Burkitt Lymphoma; Stage III Adult Burkitt Lymphoma; Stage IV Adult Burkitt Lymphoma; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia

Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition
Status: Completed Condition: Fasting State

APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
Status: Completed Condition: Syndrome X

A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient
Status: Recruiting Condition: Chronic Kidney Disease

Allopurinol Add-on Treatment for Refractory Mania
Status: Completed Condition: Bipolar Disorder; Mixed Mania; Treatment-Resistant Mania

RDEA3170 and Allopurinol Combination Study in Gout Subjects
Status: Active, not recruiting Condition: Gout

Intravenous Allopurinol to Improve Heart Function in Individuals With Dilated Cardiomyopathy
Status: Withdrawn Condition: Cardiovascular Diseases; Cardiomyopathy, Dilated; Heart Diseases; Heart Failure, Congestive

The Effect of Allopurinol on Insulin Resistance and Blood Pressure
Status: Completed Condition: Metabolic Syndrome

Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol
Status: Completed Condition: Leishmaniasis, Cutaneous

Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Status: Completed Condition: Gout

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Status: Completed Condition: Gout

Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol
Status: Completed Condition: Gout; Hyperuricemia; Arthritis; Joint Disease

Efficacy of Allopurinol and Dypiridamole in Acute Mania
Status: Completed Condition: Mania

Antenatal Allopurinol in Intrauterine Growth Restriction
Status: Not yet recruiting Condition: Fetal Growth Retardation

Allopurinol as a Possible Oxygen Sparing Agent During Exercise in Peripheral Arterial Disease
Status: Completed Condition: Peripheral Arterial Disease

A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
Status: Completed Condition: Gout; Hyperuricemia; Arthritis; Joint Disease; Renal Insufficiency

Prednisone for Heart Failure Patients With Hyperuricemia
Status: Completed Condition: Heart Failure; Hyperuricemia

Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies
Status: Completed Condition: Tumor Lysis Syndrome

Allopurinol in Chronic Heart Failure
Status: Completed Condition: Chronic Heart Failure; Hyperuricemia

Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Status: Completed Condition: Tumor Lysis Syndrome; Cancer; Hyperuricemia

Efficacy and Safety of Oral Febuxostat in Participants With Gout
Status: Completed Condition: Gout

Evaluating Efficacy of Canakinumab (ACZ885) in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy
Status: Completed Condition: Gout

Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
Status: Completed Condition: Heart Failure; Elevated Serum Uric Acid

Allopurinol for Renal Transplant Associated Hypertension in Children
Status: Terminated Condition: Hypertension; Renal Transplant

Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Status: Completed Condition: Gout and Hyperuricemia

Intravenous Allopurinol in Heart Failure
Status: Recruiting Condition: Congestive Heart Failure

Impact of Diabetes on Left Ventricular Remodeling
Status: Completed Condition: Diabetes

Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
Status: Completed Condition: Leishmaniasis

Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients
Status: Completed Condition: Chronic Heart Failure

Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Status: Completed Condition: Gout

Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients
Status: Completed Condition: Gout

IVIVR Assessing PK Parameters Used to Establish Bioequivalence
Status: Not yet recruiting Condition: Healthy

Uric Acid in Essential Hypertension in Children
Status: Completed Condition: Essential Hypertension

Uric Acid and Hypertension in African Americans
Status: Completed Condition: Cardiovascular Diseases; Heart Diseases; Hypertension

The Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure
Status: Completed Condition: Hyperuricemia; Chronic Kidney Disease

Combining Lesinurad With Allopurinol in Inadequate Responders
Status: Completed Condition: Gout

Combining Lesinurad With Allopurinol in Inadequate Responders
Status: Completed Condition: Gout

Lesinurad and Allopurinol Combination Extension Study in Gout
Status: Active, not recruiting Condition: Gout

A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
Status: Completed Condition: Gout

Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2
Status: Recruiting Condition: Leukemia; Lymphoma

Effect of Allopurinol Treatment on Insulin Resistance
Status: Recruiting Condition: Hyperuricemia; Prediabetes; Insulin Resistance

Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Status: Completed Condition: Intercritical Gout

Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
Status: Completed Condition: Kidney Disease; Left Ventricular Hypertrophy

Study of Cardiovascular Disease and Obstructive Sleep Apnea
Status: Recruiting Condition: Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour); Hypertension

DECT Study in Allopurinol-Treated Gout Patients
Status: Not yet recruiting Condition: Gout

UAB Center of Research Translation (CORT) Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure
Status: Recruiting Condition: Pre-hypertension; JNC 7 Stage I Hypertension

Uric Acid and the Endothelium is CKD
Status: Recruiting Condition: Kidney Disease

Prednisone for Heart Failure Patients With Hyperuricemia
Status: Recruiting Condition: Heart Failure, Hyperuricemia

Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
Status: Terminated Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
Status: Completed Condition: Schizophrenia

Genetics of Hyperuricemia Therapy in Hmong
Status: Recruiting Condition: Hyperuricemia, Gout

Xanthine Oxidase Inhibition in Renal Transplant Recipients
Status: Recruiting Condition: Complications of Renal Transplant

Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma
Status: Completed Condition: Adult Acute Lymphocytic Leukemia; High-Grade Lymphoma

A Controlled Study of Uric Acid on the Progression of IgA Nephropathy
Status: Completed Condition: IgA Nephropathy

Busulfan and Cyclophosphamide Followed By ALLO BMT
Status: Recruiting Condition: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome

Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function
Status: Active, not recruiting Condition: Renal Function; Endothelial Function; Blood Pressure; Overweight; Obesity

Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)
Status: Active, not recruiting Condition: Chronic Lymphocytic Leukemia

Xanthine Oxidase Inhibition for Improvement of Long-term Outcomes Following Ischaemic Stroke and Transient Ischaemic Attack
Status: Not yet recruiting Condition: Ischaemic Stroke

T-Cell Depleted Double UCB for Refractory AML
Status: Recruiting Condition: Acute Myelogenous Leukemia; Refractory Acute Myelogenous Leukemia

T-Regulatory Cell Infusion Post Umbilical Cord Blood Transplant in Patients With Advanced Hematologic Cancer
Status: Recruiting Condition: Leukemia; Lymphoma; Multiple Myeloma; Plasma Cell Neoplasm; Myelodysplastic Syndromes

PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
Status: Completed Condition: Gout

PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Status: Completed Condition: Intercritical Gout

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
Status: Completed Condition: Lymphoma, Non-Hodgkin; HIV Infections

Vascular Pathophysiology in Obstructive Sleep Apnea
Status: Withdrawn Condition: Obstructive Sleep Apnea

The Predictors of Successful Oral Dissolution Therapy in Radiolucent Renal Stones; A Prospective Evaluation
Status: Recruiting Condition: Urolithiasis; Renal Stones

Hyperuricemia on Hypertension and Metabolic Syndrome
Status: Completed Condition: Systolic and Diastolic Blood Pressure Levels; Uric Acid Levels; Metabolic Syndrome Parameters; Hepatic Enzymes

S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Status: Completed Condition: Leukemia

Rasburicase (Fasturtec) Registration Trial
Status: Terminated Condition: Hyperuricemia

INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Status: Completed Condition: Non-Hodgkin's Lymphoma; Cancer

Inflammatory Mediators in Obstructive Sleep Apnoea Syndrome; Mechanisms of Production and the Effect of Long Term Antioxidants Administration
Status: Recruiting Condition: Obstructive Sleep Apnea Syndrome

Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Status: Terminated Condition: Gout

Phase III Trial of Febuxostat in Korea Gout Patients
Status: Completed Condition: Gout

An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Status: Completed Condition: Diabetic Autonomic Neuropathy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purepac Pharm
ALLOPURINOL
allopurinol
TABLET;ORAL070579-001Apr 14, 1986DISCNNo<disabled><disabled>
Northstar Hlthcare
ALLOPURINOL
allopurinol
TABLET;ORAL078253-002Sep 11, 2007RXNo<disabled><disabled>
Watson Labs
ALLOPURINOL
allopurinol
TABLET;ORAL018877-001Sep 28, 1984RXNo<disabled><disabled>
Dr Reddys La
LOPURIN
allopurinol
TABLET;ORAL071587-001Apr 2, 1987RXNo<disabled><disabled>
Vintage Pharms
ALLOPURINOL
allopurinol
TABLET;ORAL075798-002Jun 27, 2003RXNo<disabled><disabled>
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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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