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Last Updated: December 13, 2024

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XOPENEX HFA Drug Patent Profile


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Which patents cover Xopenex Hfa, and when can generic versions of Xopenex Hfa launch?

Xopenex Hfa is a drug marketed by Lupin and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in eighteen countries.

The generic ingredient in XOPENEX HFA 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 Hfa

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for XOPENEX HFA
Drug Prices for XOPENEX HFA

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Drug Sales Revenue Trends for XOPENEX HFA

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Recent Clinical Trials for XOPENEX HFA

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SponsorPhase
Henry Ford Health SystemPhase 4
Ascension Genesys HospitalPhase 4
Fahim Khorfan, MDPhase 4

See all XOPENEX HFA clinical trials

Pharmacology for XOPENEX HFA
Paragraph IV (Patent) Challenges for XOPENEX HFA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XOPENEX HFA Inhalation Aerosol levalbuterol tartrate 0.045 mg/actuation 021730 1 2012-02-27

US Patents and Regulatory Information for XOPENEX HFA

XOPENEX HFA is protected by one US patents.

Patents protecting XOPENEX HFA

Levalbuterol salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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 HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Sign Up ⤷  Sign Up
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Sign Up ⤷  Sign Up
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Sign Up ⤷  Sign Up
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Sign Up ⤷  Sign Up
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.