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Last Updated: October 24, 2021

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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. 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. Thirteen suppliers are listed for this compound.

Summary for levalbuterol hydrochloride
US Patents:1
Tradenames:2
Applicants:9
NDAs:11
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 13
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 31
Patent Applications: 1,310
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
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
Luoxin Aurovitas LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625-001 Dec 30, 2016 AN RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sun Pharm LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207820-002 Nov 5, 2018 AN RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Luoxin Aurovitas LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625-002 Dec 30, 2016 AN RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva Pharms Usa LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 090297-002 Apr 26, 2013 AN RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ⤷  Free Forever Trial ⤷  Free Forever 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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