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Last Updated: January 30, 2023

Levalbuterol hydrochloride - Generic Drug Details


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What are the generic drug sources for levalbuterol hydrochloride and what is the scope of freedom to operate?

Levalbuterol hydrochloride is the generic ingredient in two branded drugs marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mylan Speciality Lp, Ritedose Corp, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Akorn, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for levalbuterol hydrochloride. Eleven suppliers are listed for this compound.

Summary for levalbuterol hydrochloride
US Patents:0
Tradenames:2
Applicants:9
NDAs:11
Drug Master File Entries: 6
Finished Product Suppliers / Packagers: 11
Raw Ingredient (Bulk) Api Vendors: 62
Clinical Trials: 33
Patent Applications: 1,413
What excipients (inactive ingredients) are in levalbuterol hydrochloride?levalbuterol hydrochloride excipients list
DailyMed Link:levalbuterol hydrochloride at DailyMed
Recent Clinical Trials for levalbuterol hydrochloride

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

SponsorPhase
University of AleppoPhase 4
Children's Hospital Los AngelesN/A
University of Illinois at ChicagoN/A

See all levalbuterol hydrochloride clinical trials

Pharmacology for levalbuterol hydrochloride
Paragraph IV (Patent) Challenges for LEVALBUTEROL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XOPENEX Inhalation Solution levalbuterol hydrochloride 0.25% 020837 1 2006-05-23
XOPENEX Inhalation Solution levalbuterol hydrochloride 0.0103%, 0.021% and 0.042% 020837 1 2005-06-20

US Patents and Regulatory Information for levalbuterol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207820-001 Nov 5, 2018 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 077800-003 Mar 15, 2013 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171-001 Dec 13, 2013 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 See Plans and Pricing See Plans and Pricing
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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