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XOPENEX Drug Profile

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Which patents cover Xopenex, and what substitute generic drugs are available?

Xopenex is a drug marketed by Oak Pharms Inc and Sunovion and is included in two NDAs. There are three 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. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

Summary for Tradename: XOPENEX

Patents:1
Applicants:2
NDAs:2
Suppliers / Packagers: see list7
Bulk Api Vendors: see list31
Clinical Trials: see list4
Patent Applications: see list4,777
Drug Prices:see details
DailyMed Link:XOPENEX at DailyMed

Pharmacology for Tradename: XOPENEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 2002RXYesYes6,451,289► Subscribe ► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-004Jul 18, 2003RXYesYes6,451,289► SubscribeY ► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 1999RXYesYes► Subscribe► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-004Jul 18, 2003RXYesYes► Subscribe► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 2002RXYesYes► Subscribe► Subscribe
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Expired Patents for Tradename: XOPENEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 19996,083,993► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 19995,362,755► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-004Jul 18, 20035,547,994► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-001Mar 25, 19995,362,755► Subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 20025,362,755► Subscribe
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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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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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