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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.

Summary for XOPENEX

US Patents:	1
Applicants:	2
NDAs:	2
Suppliers / Packagers:	5
Bulk Api Vendors:	32
Clinical Trials:	6
Patent Applications:	4,066
Drug Prices:	Drug price information for XOPENEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XOPENEX
DailyMed Link:	XOPENEX at DailyMed

Pharmacology for XOPENEX

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

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
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	AN	RX	Yes	Yes			Y
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	AN	RX	Yes	Yes
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	AN	RX	Yes	Yes
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002	AN	RX	Yes	Yes
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	AN	RX	Yes	Yes

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
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999

Paragraph IV (Patent) Challenges for XOPENEX

Drugname	Dosage	Strength	RLD	Date
	Inhalation Aerosol	0.045 mg/actuation
	Inhalation Solution	0.0025
	Inhalation Solution	0.0103%, 0.021% and 0.042%