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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

Xopenex was eligible for patent challenges on December 31, 1968.

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

Summary for XOPENEX

US Patents:	1
Applicants:	2
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	33
Clinical Trials:	6
Patent Applications:	4,452
Drug Prices:	Drug price information for XOPENEX
Drug Sales Revenues:	Drug sales revenues for XOPENEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XOPENEX
DailyMed Link:	XOPENEX at DailyMed

See drug prices for XOPENEX

See drug sales revenues for XOPENEX

Recent Clinical Trials for XOPENEX

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Genesys Regional Medical Center	Phase 4
Fahim Khorfan, MD	Phase 4

See all XOPENEX clinical trials

Recent Litigation for XOPENEX

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Sepracor Inc. v. Barr Laboratories Inc.	2007-07-12
Sepracor Inc. v. Dey LP	2006-09-27
Sunovion Pharmaceuticals v. Dey Pharma	2006-02-22

See all XOPENEX litigation

Pharmacology for XOPENEX

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

Synonyms for XOPENEX

(-)-Albuterol

(-)-alpha(sup 1)-(((1,1-Dimethylethyl)amino)methyl)-4-hydroxy-1,3-benzenedimethanol

(-)-Salbutamol

(R) - Albuterol

(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-hydroxy-ethyl]-2-(hydroxymethyl)phenol

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

AC1L3WY7

ACM34391043

AJ-08305

AKOS005552518

alpha-1-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol

AN-14841

API0003155

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

I14-48286

J-019582

Jsp006235

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)-(-)-

MolPort-006-830-342

NCGC00015955-01

NCGC00015955-02

NCGC00015955-03

NCGC00016736-01

NCGC00024698-01

NDAUXUAQIAJITI-LBPRGKRZSA-N

R-Albuterol

R-Salbutamol

Salbutamol;4-(2-tert-Butylamino-1-hydroxy-ethyl)-2-hydroxymethyl-phenol

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
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	020837-002	Mar 25, 1999	AN	RX	Yes	Yes
Sunovion	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005		RX	Yes	Yes			Y

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	020837-002	Mar 25, 1999
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002
Oak Pharms Inc	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999