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Last Updated: October 25, 2020

DrugPatentWatch Database Preview

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 Aurobindo Pharma Ltd, Cipla, Impax Labs Inc, Mylan Speciality Lp, Ritedose Corp, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Oak Pharms Inc, and is included in eleven NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for levalbuterol hydrochloride. Twelve suppliers are listed for this compound.

Summary for levalbuterol hydrochloride
Recent Clinical Trials for levalbuterol hydrochloride

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SponsorPhase
Children's Hospital Los AngelesN/A
National Heart, Lung, and Blood Institute (NHLBI)N/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 NDA Submissiondate
XOPENEX SOLUTION;INHALATION levalbuterol hydrochloride 020837 2006-05-23
XOPENEX SOLUTION;INHALATION levalbuterol hydrochloride 020837 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 207820-003 Nov 5, 2018 AN RX No No   Start Trial   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharms Usa LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 090297-003 Apr 26, 2013 AN RX No No   Start Trial   Start Trial   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 levalbuterol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Medtronic
Merck
Johnson and Johnson
Colorcon

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