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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-nine 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 / Packagers: see list9

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

A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent 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

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

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

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

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

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>
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Expired Patents for Tradename: PROAIR HFA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 20045,605,674<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 20045,695,743<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 20045,766,573<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
Germany69232034Jun 06, 2002
JapanH07502275Mar 09, 1995
Austria150296Apr 15, 1997
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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