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Profile for Tradename: PROAIR HFA

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Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from seven suppliers. There are five patents protecting this drug.

This drug has sixty-eight patent family members in twenty-one countries.

The generic ingredient in PROAIR 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: PROAIR HFA

Patents:5
Applicants:1
NDAs:1
Suppliers: see list7

Pharmacology for Tradename: PROAIR HFA

Clinical Trials for: PROAIR HFA

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

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

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

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

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

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)

The Various Effects of Gaseous Albuterol on Serum Lactate
Status: Recruiting Condition: 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
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes6,446,627<disabled>Y<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes7,105,152<disabled>Y<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes7,566,445<disabled>Y<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes8,834,849<disabled>Y<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes8,132,712<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: PROAIR 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
6,743,413 Suspension aerosol formulations<disabled in preview>
7,101,534Suspension aerosol formulations<disabled in preview>
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International Patent Family for Tradename: PROAIR HFA

Country Document Number Publication Date
Denmark0717987Nov 12, 2001
European Patent Office2135199Dec 23, 2009
Germany69233319Feb 17, 2005
Japan3908269Apr 25, 2007
European Patent Office1086688Mar 28, 2001
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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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