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Last Updated: November 21, 2024

LEVALBUTEROL HYDROCHLORIDE Drug Patent Profile


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Which patents cover Levalbuterol Hydrochloride, and what generic alternatives are available?

Levalbuterol Hydrochloride is a drug marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mylan Speciality Lp, Norvium Bioscience, Ritedose Corp, Sun Pharm, Teva Parenteral, and Teva Pharms Usa. and is included in ten NDAs.

The generic ingredient in LEVALBUTEROL HYDROCHLORIDE is levalbuterol hydrochloride. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Levalbuterol Hydrochloride

A generic version of LEVALBUTEROL HYDROCHLORIDE was approved as levalbuterol hydrochloride by IMPAX LABS INC on April 9th, 2008.

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Summary for LEVALBUTEROL HYDROCHLORIDE
US Patents:0
Applicants:9
NDAs:10
Finished Product Suppliers / Packagers: 11
Raw Ingredient (Bulk) Api Vendors: 50
Clinical Trials: 33
Patent Applications: 947
What excipients (inactive ingredients) are in LEVALBUTEROL HYDROCHLORIDE?LEVALBUTEROL HYDROCHLORIDE excipients list
DailyMed Link:LEVALBUTEROL HYDROCHLORIDE at DailyMed
Drug patent expirations by year for LEVALBUTEROL HYDROCHLORIDE
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
Cipla LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171-002 Dec 13, 2013 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207820-001 Nov 5, 2018 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 090297-003 Apr 26, 2013 AN RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Luoxin Aurovitas LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207628-001 Jan 31, 2017 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 077756-003 Apr 9, 2008 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 077800-001 Mar 15, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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