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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Dow
Cerilliant
US Department of Justice
Medtronic
Julphar
Colorcon
Teva
Boehringer Ingelheim

Generated: June 19, 2018

DrugPatentWatch Database Preview

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. Five suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
Drug patent expirations by year for XOPENEX
Pharmacology for XOPENEX
Synonyms for XOPENEX
(-)-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 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)-
148563-16-0
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
AK307325
AKOS015961919
alfa1-[[1,1-Dimethylethylamino]methyl]-4-hydroxy-1-(S),3-benzene dimethanol Hydrochlorid
AN-41529
BC209011
BG0555
BS-1006
C13H22ClNO3
CCG-39986
CHEMBL1201061
D02281
DTXSID20198296
FT-0621958
Levalbuterol HCl
Levalbuterol hydrochloride
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
R-ALBUTEROLHYDROCHLORIDE
S105
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 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 ➤ 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
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes ➤ 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 ➤ 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 XOPENEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 020837-002 Mar 25, 1999 ➤ 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 020837-003 Jan 30, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for XOPENEX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Inhalation Aerosol 0.045 mg/actuation ➤ Subscribe 2012-02-27
➤ Subscribe Inhalation Solution 0.0025 ➤ Subscribe 2006-05-23
➤ Subscribe Inhalation Solution 0.0103%, 0.021% and 0.042% ➤ Subscribe 2005-06-20

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Deloitte
Mallinckrodt
Dow
Merck
Johnson and Johnson
McKinsey
AstraZeneca

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.