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Details for Generic Name: albuterol sulfate

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Albuterol sulfate is the generic ingredient in fifteen branded drugs marketed by Teva Branded Pharm, 3M, Glaxosmithkline, Mylan Speclt, Actavis Mid Atlantic, Apotex Inc, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Nephron, Ritedose Corp, Roxane, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, G And W Labs Inc, Mova, Teva, Vintage, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Mutual Pharm, Pliva, Sandoz, Ucb Inc, Warner Chilcott, Boehringer Ingelheim, Cipla Ltd, and Sandoz Inc, and is included in eigthy-three NDAs. There are fifty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and ninety-nine patent family members in twenty-nine countries.

There are thirty-five drug master file entries for albuterol sulfate. Eighteen suppliers are listed for this compound.

Summary for Generic Name: albuterol sulfate

Tradenames:15
Patents:51
Applicants:36
NDAs:83
Drug Master File Entries: see list35
Suppliers / Packaging: see list39
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: albuterol sulfate

Clinical Trials for: albuterol sulfate

Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction
Status: Terminated Condition: Asthma; Bronchospasm

Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children
Status: Completed Condition: Airway Disease; Asthma; Acute Wheezing

Preterm Infant Inhaled Albuterol Dosing
Status: Recruiting Condition: Bronchopulmonary Dysplasia; Very Low Birth Weight

Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate
Status: Completed Condition: Healthy Volunteers

Salbutamol, Pharmacogenetics and Breathing Mechanics
Status: Active, not recruiting Condition: Exercise-induced Bronchoconstriction,; Inhaled Salbutamol; Cycling Performance

Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
Status: Completed Condition: Asthma

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Status: Completed Condition: Asthma

Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning
Status: Recruiting Condition: Organophosphate Poisoning

Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
Status: Completed Condition: Allergic Asthma

A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Status: Completed Condition: Asthma

Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
Status: Completed Condition: Reactive Airways Disease (RAD)

Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
Status: Completed Condition: Exercise-Induced Bronchoconstriction (EIB)

The Various Effects of Gaseous Albuterol on Serum Lactate
Status: Recruiting Condition: Asthma

Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma
Status: Completed Condition: Asthma

Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
Status: Completed Condition: Asthma

4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma
Status: Terminated Condition: Asthma

Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma
Status: Completed Condition: Bronchial Asthma

A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma
Status: Completed Condition: Asthma

Study to Evaluate the Pharmacokinetic Profile of Salbutamol Delivered by Unit Dose Dry Powder Inhaler (UD-DPI) Compared to the Diskus and Metered Dose Inhaler (MDI) in Healthy Volunteers.
Status: Completed Condition: Asthma

Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
Status: Terminated Condition: Asthma

Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects
Status: Completed Condition: Asthma; COPD

Comparative Study on the Efficacy and Safety of Procaterol Versus Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room
Status: Completed Condition: Asthma

Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma
Status: Completed Condition: Asthma

Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
Status: Completed Condition: Asthma

Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma
Status: Completed Condition: Asthma

Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
Status: Completed Condition: Asthma

Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Status: Completed Condition: Asthma

Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)
Status: Completed Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Efficacy of Albuterol in the Treatment of Congenital Myasthenic Syndromes
Status: Completed Condition: Congenital Myasthenic Syndrome

Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
Status: Completed Condition: Asthma

A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects
Status: Terminated Condition: Asthma

Dose Finding Study of Albuterol Sulfate in Patients With Intermittent or Persistent Mild Asthma
Status: Not yet recruiting Condition: Asthma

Comparison of Single-Dose Efficacy of an Albuterol Breath Activated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered Dose Inhaler (HFA-MDI) (Both Using the Same Hydrofluoroalkane Propellant) in Asthmatics
Status: Completed Condition: Asthma

Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Status: Completed Condition: Asthma

Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients
Status: Completed Condition: COPD

A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing
Status: Terminated Condition: Asthma

Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
Status: Completed Condition: Asthma

Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
Status: Completed Condition: Healthy

Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
Status: Completed Condition: Healthy

Drug Study of Albuterol to Treat Acute Lung Injury
Status: Terminated Condition: Respiratory Distress Syndrome, Adult

Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique
Status: Completed Condition: Asthma

Budesonide Inhalation Suspension for Acute Asthma in Children
Status: Completed Condition: Asthma; Acute Asthma; Reactive Airway Exacerbation

A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)
Status: Completed Condition: Asthma

Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol
Status: Withdrawn Condition: Asthma

The Effect of Nebulized Albuterol on Donor Oxygenation
Status: Completed Condition: Brain Death; Organ Donor; Pulmonary Edema

Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
Status: Recruiting Condition: Idiopathic Pulmonary Arterial Hypertension.

Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
Status: Completed Condition: Asthma

Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects
Status: Completed Condition: Memory Functions

A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
Status: Completed Condition: Asthma

Hypertonic Saline for Outpatient Bronchiolitis
Status: Recruiting Condition: Bronchiolitis; Respiratory Distress

A Safety and Tolerability Study of Levalbuterol HFA Metered Dose Inhaler in Subjects With Asthma
Status: Completed Condition: Asthma

Efficacy and Safety of Increasing Doses of Inhaled Albuterol Administered by Metered Dose Inhalers in Children With Acute Wheezing Episodes
Status: Recruiting Condition: Asthma; Children

Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma
Status: Completed Condition: Asthma

IPF Drug Deposition Study
Status: Completed Condition: Idiopathic Pulmonary Fibrosis

Chronic-Dose Safety and Efficacy Study of an Albuterol Metered Dose Inhaler (MDI) Inhaler Using a Hydrofluoroalkane (HFA) Propellant In Pediatric Asthmatics
Status: Completed Condition: Asthma

Nebulized Albuterol for Congestive Heart Failure Exacerbation
Status: Withdrawn Condition: Congestive Heart Failure

Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
Status: Completed Condition: Asthma

Inhaled Salbutamol in Elective Caesarean Section
Status: Recruiting Condition: Postnatal Pulmonary Adaptation; Cesarean Section

Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms
Status: Completed Condition: Bronchial Asthma

Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
Status: Completed Condition: Asthma

Albuterol in Individuals With Late Onset Pompe Disease (LOPD)
Status: Completed Condition: Pompe Disease

Salbutamol Tolerance Onset
Status: Completed Condition: Asthma

Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics
Status: Completed Condition: Asthma

A Study to Assess the Systemic Exposure of FLIXOTIDE™ (Fluticasone Propionate) and SERETIDE™ (Fluticasone Propionate and Salmeterol) Given With VENTOLIN™ Mini-Spacer Compared to the Aerochamber Plus Spacer
Status: Completed Condition: Asthma

Genetic Determinants of the Response to Salbutamol Among Asthma Patients
Status: Recruiting Condition: Asthma

Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
Status: Recruiting Condition: Lymphangioleiomyomatosis

Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB
Status: Completed Condition: Exercise-induced Bronchospasm

Effect of Nebulized Bronchodilators on Heart Rate
Status: Completed Condition: COPD; CABG Surgery; Sepsis; Shock; Ventilators, Mechanical

A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
Status: Completed Condition: Asthma

A Study of LY2216684 in Healthy Subjects Receiving Albuterol or Propanolol
Status: Completed Condition: Major Depressive Disorder

Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
Status: Completed Condition: Asthma; Bronchospasm

Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
Status: Completed Condition: Asthma; Chronic Obstructive Pulmonary Disease; COPD

Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

Treatment of Multiple Sclerosis With Copaxone and Albuterol
Status: Completed Condition: Autoimmune Diseases; Multiple Sclerosis

A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
Status: Completed Condition: Asthma

Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
Status: Completed Condition: Moderate and Severe Acute Asthma Exacerbations in Pediatric Patients

Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects
Status: Completed Condition: Asthma; Bronchoconstriction

A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients
Status: Completed Condition: Asthma

Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol
Status: Completed Condition: Asthma; Bronchoconstriction

Dose-response of Albuterol in Asthmatics
Status: Completed Condition: Asthma

Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)
Status: Recruiting Condition: CHRONIC OBSTRUCTIVE PULMONARY DISEASE; ASTHMA; HEALTHY SUBJECTS

Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol
Status: Completed Condition: Asthma

Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease
Status: Recruiting Condition: Asthma; COPD

The Effect of High Dose Salbutamol on Muscle Performance
Status: Active, not recruiting Condition: Ergogenic Effects of Salbutamol in Healthy Males

Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
Status: Completed Condition: Chronic Obstructive Pulmonary Disease

Comparison of RPL554 With Placebo and Salbutamol in Asthmatic Patients
Status: Recruiting Condition: Asthma

Effect of the Salbutamol on Mechanical Properties of Respiratory System
Status: Recruiting Condition: Smoking; Airway Obstruction

To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
Status: Completed Condition: Asthma

Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler Compared to Ipratropium Bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo in Adults With Chronic Obstructive Pulmonary Disease
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs.
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

Symbicort Onset of Action 2
Status: Completed Condition: Asthma

Symbicort Onset of Action 1
Status: Completed Condition: Asthma

The Effects Of Bronchodilator Therapy On Respiratory And Autonomic Function In Patients With Familial Dysautonomia
Status: Completed Condition: Familial Dysautonomia

Study of Dose-response to Bronchodilator and Dose-finding in Child 2.5 to 6 Years - Study Golden
Status: Completed Condition: Asthma

Effectiveness and Cost Study Comparing Two Ways to Deliver Albuterol for the Treatment of Asthma in the Hospital
Status: Completed Condition: Status Asthmaticus

Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Status: Completed Condition: Asthma

A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
Status: Completed Condition: Asthma

Acute Asthma Responsiveness and B2 Adrenergic Receptors Polymorphisms
Status: Recruiting Condition: Acute Asthma

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
Vintage
ALBUTEROL SULFATE
albuterol sulfate
SYRUP;ORAL078105-001Dec 27, 2006RXNo<disabled><disabled>
Watson Labs
ALBUTEROL SULFATE
albuterol sulfate
TABLET;ORAL072764-001Aug 28, 1991DISCNNo<disabled><disabled>
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes6,966,467*PED<disabled>Y<disabled>
Teva Pharms
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION075343-001Nov 9, 1999RXNo<disabled><disabled>
Dava Pharms Inc
VOSPIRE ER
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL076130-002Sep 26, 2002RXNo<disabled><disabled>
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International Patent Family for Ingredient: albuterol sulfate

Country Document Number Publication Date
Argentina028746May 21, 2003
European Patent Office1667627Apr 28, 2010
Australia8464301Jan 02, 2002
European Patent Office2189176May 26, 2010
Denmark0918507Jul 29, 2002
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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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