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Levalbuterol tartrate - Generic Drug Details

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Levalbuterol tartrate is the generic ingredient in one branded drug marketed by Sunovion and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-seven patent family members in eighteen countries.

There are nine drug master file entries for levalbuterol tartrate. Two suppliers are listed for this compound.

Summary for Generic Name: levalbuterol tartrate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packaging: see list2
Drug Prices:see low prices

Pharmacology for Ingredient: levalbuterol tartrate

Clinical Trials for: levalbuterol tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 2005RXYesMar 12, 2018
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 2005RXYes8,765,153Dec 8, 2023Y
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 2005RXYes7,256,310Oct 8, 2024YY
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Expired Orange Book Patents for Generic Ingredient: levalbuterol tartrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,225,183<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,836,299<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730-001Mar 11, 20055,844,002<disabled>
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International Patent Family for Ingredient: levalbuterol tartrate

Country Document Number Estimated Expiration
European Patent Office1572622<disabled in preview>
World Intellectual Property Organization (WIPO)9502651<disabled in preview>
JapanH09500300<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.

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