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Profile for Tradename: XOPENEX

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Xopenex is a drug marketed by Oak Pharms Inc and Sunovion and is included in two NDAs. It is available from nine suppliers. There are four patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in XOPENEX 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

Patents:4
Applicants:2
NDAs:2
Suppliers / Packagers: see list23

Pharmacology for Tradename: XOPENEX

Clinical Trials for: XOPENEX

Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
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

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

Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
Status: Completed Condition: Reactive Airways Disease (RAD)

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

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

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

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
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 2002RXYes6,451,289<disabled> <disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-004Jul 18, 2003RXYes6,451,289<disabled>Y <disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 1999RXYes<disabled><disabled>
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Expired Patents for Tradename: XOPENEX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 19995,362,755<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 20025,362,755<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 19995,547,994<disabled>
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Paragraph IV activity for: XOPENEX

Drugname Dosage Strength RLD Submissiondate
levalbuterol tartrateInhalation Aerosol0.045 mg/actuationXopenex2/27/2012
levalbuterol hydrochlorideInhalation Solution0.0025Xopenex5/23/2006
levalbuterol hydrochlorideInhalation Solution0.0103%, 0.021% and 0.042%Xopenex6/20/2005
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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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