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Last Updated: March 19, 2024

XOPENEX Drug Patent Profile


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Which patents cover Xopenex, and what generic alternatives are available?

Xopenex is a drug marketed by Hikma and Lupin and is included in two NDAs. There is one patent protecting this drug and two 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.

DrugPatentWatch® Generic Entry Outlook for Xopenex

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for XOPENEX
Drug Prices for XOPENEX

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Drug Sales Revenue Trends for XOPENEX

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Recent Clinical Trials for XOPENEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Henry Ford Health SystemPhase 4
Fahim Khorfan, MDPhase 4
Genesys Regional Medical CenterPhase 4

See all XOPENEX clinical trials

Paragraph IV (Patent) Challenges for XOPENEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XOPENEX Inhalation Solution levalbuterol hydrochloride 0.25% 020837 1 2006-05-23
XOPENEX Inhalation Solution levalbuterol hydrochloride 0.0103%, 0.021% and 0.042% 020837 1 2005-06-20

US Patents and Regulatory Information for XOPENEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 AN RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for XOPENEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for XOPENEX

See the table below for patents covering XOPENEX around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0560954 COMPOSITIONS DE TRAITEMENT ET TISSUS POLYMERES TRAITES AVEC CES DERNIERES (COMPOSITIONS AND POLYMER FABRICS TREATED WITH THE SAME) ⤷  Try a Trial
Singapore 86293 COMPOSITIONS AND POLYMER FABRICS TREATED WITH THE SAME ⤷  Try a Trial
Spain 2088152 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.