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Generated: December 13, 2018

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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.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 AN RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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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 020837-004 Jul 18, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
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 Date
➤ Subscribe Inhalation Aerosol 0.045 mg/actuation ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Inhalation Solution 0.0025 ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Inhalation Solution 0.0103%, 0.021% and 0.042% ➤ Subscribe ➤ Try a Free Trial

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Medtronic
AstraZeneca
Cerilliant
Daiichi Sankyo
Merck
Colorcon
Healthtrust
Fish and Richardson

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