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Levalbuterol hydrochloride - Generic Drug Details

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Levalbuterol hydrochloride is the generic ingredient in two branded drugs marketed by Mylan Speclt, Aurobindo Pharma Ltd, Oak Pharms Inc, Ritedose Corp, Impax Labs Inc, Cipla Ltd, Teva Parenteral, and Teva Pharms Usa, and is included in ten NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for levalbuterol hydrochloride. Sixteen suppliers are listed for this compound.

Summary for Generic Name: levalbuterol hydrochloride

Tradenames:2
Patents:1
Applicants:8
NDAs:10
Drug Master File Entries: see list9
Suppliers / Packagers: see list16
Bulk Api Vendors: see list27
Clinical Trials: see list1,005
Patent Applications: see list551
Therapeutic Class:Respiratory Tract Agents
Drug Prices:see low prices
DailyMed Link:levalbuterol hydrochloride at DailyMed

Pharmacology for Ingredient: levalbuterol hydrochloride

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;INHALATION020837-004Jul 18, 2003RXYesYes► subscribe► subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 1999RXYesYes6,451,289► subscribe ► subscribe
Impax Labs Inc
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION077756-001Apr 9, 2008RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: levalbuterol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 20025,547,994► subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-004Jul 18, 20035,844,002► subscribe
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 19995,760,090► subscribe
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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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