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Last Updated: June 28, 2022

XOPENEX Drug Patent 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 two 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. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

DrugPatentWatch® Generic Entry Outlook for Xopenex

Annual sales in 2019 were $19mm indicating the motivation for generic entry (peak sales were $558mm in 2011).

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
Ascension Genesys HospitalPhase 4
Fahim Khorfan, MDPhase 4

See all XOPENEX clinical trials

Pharmacology for XOPENEX
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
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 AN RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 020837-002 Mar 25, 1999 See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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