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Last Updated: March 19, 2024

Levalbuterol tartrate - Generic Drug Details


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What are the generic sources for levalbuterol tartrate and what is the scope of patent protection?

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

Levalbuterol tartrate has thirty-six patent family members in eighteen countries.

Four suppliers are listed for this compound.

Summary for levalbuterol tartrate
International Patents:36
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 4
Clinical Trials: 5
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for levalbuterol tartrate
What excipients (inactive ingredients) are in levalbuterol tartrate?levalbuterol tartrate excipients list
DailyMed Link:levalbuterol tartrate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for levalbuterol tartrate
Generic Entry Date for levalbuterol tartrate*:
Constraining patent/regulatory exclusivity:
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 levalbuterol tartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
SunovionPhase 2
SunovionPhase 3

See all levalbuterol tartrate clinical trials

Pharmacology for levalbuterol tartrate
Paragraph IV (Patent) Challenges for LEVALBUTEROL TARTRATE
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 levalbuterol tartrate

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a 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 levalbuterol tartrate

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 ⤷  Try a Trial ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Try a Trial ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Try a Trial ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Try a Trial ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 ⤷  Try a Trial ⤷  Try a 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 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.