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Last Updated: February 28, 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 are two patents 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:2
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
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 ⤷  Try a Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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