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Profile for Tradename: PROVENTIL-HFA

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Proventil-hfa is a drug marketed by 3M and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug.

This drug has twenty-nine patent family members in eleven countries.

The generic ingredient in PROVENTIL-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: PROVENTIL-HFA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list5

Pharmacology for Tradename: PROVENTIL-HFA

Clinical Trials for: PROVENTIL-HFA

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

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

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

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

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

A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Status: Completed 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
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 1996RXYes5,775,321<disabled>Y<disabled>
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 1996RXYes6,006,745<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: PROVENTIL-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
6,036,942 Seal configuration for aerosol canister<disabled in preview>
6,030,682 Container for aerosol formulation<disabled in preview>
5,290,539 Device for delivering an aerosol<disabled in preview>
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International Patent Family for Tradename: PROVENTIL-HFA

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9211190Aug 20, 1992
Germany69114725Mar 28, 1996
Germany69128157Jun 10, 1998
Japan3588113Nov 10, 2004
Germany69406916Jun 25, 1998
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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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