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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

XOPENEX HFA Drug 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 Sunovion and is included in one NDA. There are two patents protecting this drug.

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.

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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Generic Entry Opportunity Date for XOPENEX HFA
Generic Entry Date for XOPENEX HFA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XOPENEX HFA

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 HFA clinical trials

Recent Litigation for XOPENEX HFA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Cipla Ltd. v. Sunovion Pharmaceuticals Inc.2015-05-26
Celgard, LLC v. Sumitomo Chemical Co., Ltd.2013-02-22
Sunovion Pharmaceuticals Inc. v. Watson Pharmaceuticals Inc.2012-07-27

See all XOPENEX HFA litigation

Pharmacology for XOPENEX HFA
Paragraph IV (Patent) Challenges for XOPENEX HFA
Tradename Dosage Ingredient NDA Submissiondate
XOPENEX HFA AEROSOL, METERED;INHALATION levalbuterol tartrate 021730 2012-02-27

US Patents and Regulatory Information for XOPENEX HFA

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

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