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Generated: July 19, 2019

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Levalbuterol hydrochloride - Generic Drug Details

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What are the generic sources for levalbuterol hydrochloride and what is the scope of levalbuterol hydrochloride patent protection?

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. Thirteen suppliers are listed for this compound.

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]

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
Ritedose Corp LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 203653-003 Mar 22, 2016 AN RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207820-003 Nov 5, 2018 AN RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs Inc LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 077756-001 Apr 9, 2008 AN RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625-003 Dec 30, 2016 AN RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 077800-001 Mar 15, 2013 AN RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Parenteral LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 200875-001 Sep 11, 2014 AN RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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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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 020837-002 Mar 25, 1999 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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