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Profile for Tradename: XOPENEX HFA

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Xopenex Hfa is a drug marketed by Sunovion and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug.

This drug has thirty-seven patent family members in eighteen countries.

The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

Summary for Tradename: XOPENEX HFA

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list4

Pharmacology for Tradename: XOPENEX HFA

Clinical Trials for: XOPENEX 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

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

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: Completed Condition: Organophosphate Poisoning

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

Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older 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
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 2005RXYes7,256,310<disabled>YY <disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 2005RXYes<disabled><disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 2005RXYes8,765,153<disabled>Y <disabled>
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Expired Patents for Tradename: XOPENEX HFA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,605,674<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,225,183<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,844,002<disabled>
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International Patent Family for Tradename: XOPENEX HFA

Country Document Number Publication Date
Israel168739Jun 30, 2011
European Patent Office1572622Sep 14, 2005
Canada2507572Jun 24, 2004
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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.

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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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