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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 eight suppliers. There are six 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:6
Applicants:2
NDAs:2
Suppliers: see list8

Pharmacology for Tradename: XOPENEX

Clinical Trials for: XOPENEX

Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning
Status: Not yet recruiting Condition: Salbutamol; Organophosphate Poisoning; Atropine

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Status: Completed Condition: Asthma

Salbutamol, Pharmacogenetics and Breathing Mechanics
Status: Active, not recruiting Condition: Exercise-induced Bronchoconstriction,; Inhaled Salbutamol; Cycling Performance

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

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

A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
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)

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;INHALATION021730Mar 11, 2005RXYes5,605,674<disabled>Y<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730Mar 11, 2005RXYes7,256,310<disabled>YY<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837Jan 30, 2002RXYes5,547,994<disabled><disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730Mar 11, 2005RXYes8,765,153<disabled>Y<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837Mar 25, 1999RXYes6,451,289<disabled><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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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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