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Profile for Tradename: VENTOLIN HFA

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Ventolin Hfa is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from twelve suppliers. There are seventeen patents protecting this drug.

The generic ingredient in VENTOLIN HFA is albuterol sulfate. There are thirty-five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

Summary for Tradename: VENTOLIN HFA

Patents:17
Applicants:1
NDAs:1
Suppliers / Packagers: see list21
2013 Sales:$745,629,000

Pharmacology for Tradename: VENTOLIN HFA

Clinical Trials for: VENTOLIN HFA

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

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

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

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

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

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

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
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes7,832,351*PED<disabled>Y<disabled>
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes6,966,467*PED<disabled>Y<disabled>
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes7,143,908*PED<disabled>Y<disabled>
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes6,510,969*PED<disabled>Y<disabled>
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes6,938,796*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: VENTOLIN HFA

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
7,101,534Suspension aerosol formulations<disabled in preview>
6,656,453 Medicaments<disabled in preview>
7,105,152Suspension aerosol formulations<disabled in preview>
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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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