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Last Updated: April 13, 2024

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 Hikma, 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: 65
Clinical Trials: 33
Patent Applications: 1,506
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
National Heart, Lung, and Blood Institute (NHLBI)N/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
Teva Pharms Usa LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 090297-001 Apr 26, 2013 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ritedose Corp LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 203653-002 Mar 22, 2016 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 077756-002 Apr 9, 2008 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ritedose Corp LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 203653-001 Mar 22, 2016 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207820-002 Nov 5, 2018 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 AN RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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