Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

LEVALBUTEROL HYDROCHLORIDE Drug Profile

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When do Levalbuterol Hydrochloride patents expire, and when can generic versions of Levalbuterol Hydrochloride launch?

Levalbuterol Hydrochloride is a drug marketed by Aurobindo Pharma Ltd, Cipla, Impax Labs Inc, Mylan Speciality Lp, 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. Thirteen suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.

Drug patent expirations by year 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

Recent Litigation for LEVALBUTEROL HYDROCHLORIDE

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District Court Litigation
Case NameDate
Sepracor Inc. v. Barr Laboratories Inc.2007-07-12
Sepracor Inc. v. Dey LP2006-09-27
Sunovion Pharmaceuticals v. Dey Pharma2006-02-22

See all LEVALBUTEROL HYDROCHLORIDE litigation

Pharmacology for LEVALBUTEROL HYDROCHLORIDE
Synonyms for LEVALBUTEROL HYDROCHLORIDE
(-)-Salbutamol hydrochloride
(|A1R)-|A1-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol Hydrochloride
(r)-(-)-a1-((tert-butylamino)methyl)-4-hydroxy-m-xylene-a,a'-diol hydrochloride
(R)-4-(2-(tert-Butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hydrochloride
(R)-albuterol
(R)-Albuterol Hydrochloride
(R)-alpha--[[1,1-dimethylethyl}amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride
(R)-alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol hydrochloride
(R)-Salbutamol ((R)-Albuterol HCl)
(R)-Salbutamol hydrochloride
1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, hydrochloride, (alpha1R)-
2-(Hydroxymethyl)-4-{(1R)-1-hydroxy-2-[(2-methyl-2-propanyl)amino ]ethyl}phenol hydrochloride (1:1)
293L908
4-[(1R)-2-(tert-butylamino)-1-hydroxy-ethyl]-2-(hydroxymethyl)phenol hydrochloride
4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol hydrochloride
50293-90-8
AC-23919
AC1L3WYA
AC1Q3F9A
ACM50293908
AKOS015961919
AN-41529
BC209011
BCP04477
BG0555
BS-1006
C13H22ClNO3
CCG-39986
CHEMBL1201061
D02281
DTXSID20198296
FT-0621958
Levalbuterol HCl
Levalbuterol hydrochloride (USAN)
Levalbuterol hydrochloride [USAN:USP]
Levalbuterol hydrochloride [USAN]
Levalbuterol hydrochloride, >=98% (HPLC)
Levalbuterol hydrochloride, United States Pharmacopeia (USP) Reference Standard
Levosalbutamol Hydrochloride
LS-175140
MolPort-003-666-750
NSC-759255
NSC759255
OWNWYCOLFIFTLK-YDALLXLXSA-N
Pharmakon1600-01505811
R-albuterol hydrochloride
S105
Salbutamol (hydrochloride) pound>>Levalbuterol pound>>(-)-Salbutamol pound>>(R)-Salbutamol
SC-47702
SCHEMBL40682
TL8002564
UNII-P12862PDAK component OWNWYCOLFIFTLK-YDALLXLXSA-N
UNII-WDQ1526QJM
WDQ1526QJM
Xopenex (TN)
Zopenex
Zopenex [common misspelling of Xopenex]
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
Aurobindo Pharma Ltd LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207628-001 Jan 31, 2017 AN RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207820-001 Nov 5, 2018 AN RX No No   Start Trial   Start Trial   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
Cipla LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171-001 Dec 13, 2013 AN RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625-003 Dec 30, 2016 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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.