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Last Updated: June 24, 2021

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XOPENEX Drug Profile


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

Xopenex is a drug marketed by Akorn and Sunovion and is included in two NDAs. There are three patents 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. Three 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
Genesys Regional Medical CenterPhase 4
Fahim Khorfan, MDPhase 4

See all XOPENEX clinical trials

Pharmacology for XOPENEX
Paragraph IV (Patent) Challenges for XOPENEX
Tradename Dosage Ingredient NDA Submissiondate
XOPENEX SOLUTION;INHALATION levalbuterol hydrochloride 020837 2006-05-23
XOPENEX SOLUTION;INHALATION levalbuterol hydrochloride 020837 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
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 AN RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 AN RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
>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
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002   Try Before You Buy   Try Before You Buy
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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