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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Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
McKesson
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McKinsey
Boehringer Ingelheim

Last Updated: November 14, 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 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.

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

Identify potential future generic entrants

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
Teva Pharms Usa LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 090297-003 Apr 26, 2013 AN RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625-001 Dec 30, 2016 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
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cipla LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171-003 Dec 13, 2013 AN RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 207625-002 Dec 30, 2016 AN RX No No   Start Trial   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes   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

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Boehringer Ingelheim
Baxter
Johnson and Johnson
Merck

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