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XOPENEX Drug Profile

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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 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 list8
Drug Prices: :see details

Pharmacology for Tradename: XOPENEX

Clinical Trials for: XOPENEX

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, 2002RXYes6,451,289Mar 21, 2021
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-004Jul 18, 2003RXYes6,451,289Mar 21, 2021Y
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 1999RXYesJan 22, 2018
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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;INHALATION020837-003Jan 30, 20025,362,755<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 19995,362,755<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 20025,844,002<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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