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Details for Generic Name: levalbuterol tartrate

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Levalbuterol tartrate is the generic ingredient in one branded drug marketed by Sunovion and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are nine drug master file entries for levalbuterol tartrate. Two suppliers are listed for this compound.

Summary for Generic Name: levalbuterol tartrate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packaging: see list4

Pharmacology for Ingredient: levalbuterol tartrate

Clinical Trials for: levalbuterol tartrate

A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects
Status: Terminated 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

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

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

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
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, 2005RXYes8,765,153<disabled>Y <disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 2005RXYes5,836,299<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: levalbuterol tartrate

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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, 20055,225,183<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,836,299<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20056,352,684<disabled>
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International Patent Family for Ingredient: levalbuterol tartrate

Country Document Number Publication Date
Germany9422364Sep 14, 2000
European Patent Office0708805Dec 22, 2010
South Korea101166955Jul 19, 2012
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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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