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Last Updated: June 3, 2020

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XOPENEX Drug Profile


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Which patents cover Xopenex, and what generic alternatives are available?

Xopenex is a drug marketed by Oak Pharms Inc and Sunovion and is included in two NDAs. There are three patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in XOPENEX is levalbuterol tartrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

US ANDA Litigation and Generic Entry Outlook for Xopenex

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for XOPENEX
Drug Prices for XOPENEX

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Drug Sales Revenue Trends for XOPENEX

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Recent Clinical Trials for XOPENEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Henry Ford Health SystemPhase 4
Fahim Khorfan, MDPhase 4
Genesys Regional Medical CenterPhase 4

See all XOPENEX clinical trials

Recent Litigation for XOPENEX

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 XOPENEX litigation

Pharmacology for XOPENEX
Synonyms for XOPENEX
(-)-Albuterol
(-)-alpha(sup 1)-(((1,1-Dimethylethyl)amino)methyl)-4-hydroxy-1,3-benzenedimethanol
(-)-Salbutamol
(R) - Albuterol
(r)-(-)-salbutamol
(R)-4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol
(R)-albuterol
(R)-alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol
(R)-alpha1-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol
(R)-salbutamol
1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, (-)-
1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, (alpha1R)-
34391-04-3
4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol
4-[(1R)-2-(tert-butylamino)-1-oxidanyl-ethyl]-2-(hydroxymethyl)phenol
68H
A822211
AC-1542
ACM34391043
AKOS005552518
Albuterol (r)-form
alpha-1-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol
API0003155
ASF-1096
BBL010806
BCP28425
BDBM50361247
BIDD:GT0508
BRD-K34469523-003-01-4
C-23839
C11770
CAS-18559-94-9
CHEBI:8746
CHEMBL1002
D08124
DB13139
DTXSID80187964
EDN2NBH5SS
F2173-0564
FT-0770967
GTPL9816
J-019582
Levalbuterol
Levolin
Levosalbutamol
Levosalbutamol (INN)
Levosalbutamol (Levalbuterol)
Levosalbutamol [INN]
Lopac-S-5013
Lopac-S-8260
LS-187796
LS-29860
m-Xylene-alpha,alpha'-diol, alpha(sup 1)-((tert-butylamino)methyl)-4-hydroxy-, (R)-(-)-
NCGC00015955-01
NCGC00015955-02
NCGC00015955-03
NCGC00016736-01
NCGC00024698-01
NDAUXUAQIAJITI-LBPRGKRZSA-N
Q408709
R-Albuterol
R-Salbutamol
SB19749
SBI-0206903.P001
SC-47248
SCHEMBL4003
STK618645
Tocris-0634
UNII-EDN2NBH5SS
UNII-QF8SVZ843E component NDAUXUAQIAJITI-LBPRGKRZSA-N
ZINC7601
Paragraph IV (Patent) Challenges for XOPENEX
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 XOPENEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 AN RX Yes Yes   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
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 XOPENEX

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 020837-001 Mar 25, 1999   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:

Colorcon
Boehringer Ingelheim
McKinsey
Dow
Harvard Business School
Mallinckrodt

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 verification 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.