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Albuterol sulfate - Generic Drug Details

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What are the generic drug sources for albuterol sulfate and what is the scope of albuterol sulfate patent protection?

Albuterol sulfate is the generic ingredient in fifteen branded drugs marketed by Teva Branded Pharm, 3m Drug Delivery, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharma Global, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, G And W Labs Inc, Lannett Co Inc, Mova, Teva, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Amneal Pharms Co, Pliva, Rising Pharms, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Yaopharma Co Ltd, Boehringer Ingelheim, Cipla Ltd, Fosun Pharma, and Watson Labs Teva, and is included in eighty-seven NDAs. There are forty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for albuterol sulfate. Forty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for albuterol sulfate

US Patents:	45
Tradenames:	15
Applicants:	42
NDAs:	87
Drug Master File Entries:	38
Suppliers / Packagers:	48
Bulk Api Vendors:	84
Clinical Trials:	24
Patent Applications:	5,872
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for albuterol sulfate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for albuterol sulfate
DailyMed Link:	albuterol sulfate at DailyMed

Pharmacology for albuterol sulfate

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

Synonyms for albuterol sulfate

.alpha.1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol sulfate (2:1) salt

(+-)-Salbutamol sulfate

(C13H21NO3)2.H2SO4

022S709

1-(4-Hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate

1, .alpha.1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-, sulfate (2:1) (salt)

1, .alpha.1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-, sulfate (2:1) salt

1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, sulfate (2:1) (salt)

1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-,sulfate (2:1) (salt)

1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, sulfate (2:1) (salt)

2-(tert-Butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Hemisulfate

2200AH

34245-12-0

36519-31-0

39971-61-4

4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hemisulfate

4-(2-(tert-Butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol sulfate

4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol; sulfuric acid

4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid

5-[2-(tert-Butylamino)-1-hydroxyethyl]-2-hydroxybenzyl Alcohol Hemisulfate

51022-70-9

AB0013333

AB1009413

AC-6369

AC1L22LX

AccuNeb

Accuneb (TN)

Accuvent

Aerotec

AH-3365

AK-51732

AK158331

AKOS015951296

AKOS015994719

Albuterol hemisulfate

Albuterol sulfate (USP)

Albuterol sulfate [USAN:USP]

Albuterol sulfate [USAN]

Albuterol sulfate, pharmaceutical secondary standard; traceable to USP, PhEur and BP

Albuterol sulfate, United States Pharmacopeia (USP) Reference Standard

Albuterol Sulfate,(S)

Albuterol sulfate(1:x)

Albuterol sulfate(2:1)

Aloprol

alpha-([t-Butylamino]methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol

alpha-[(tert-Butylamino)methyl]-4-hydroxy-1,3-benzenedimethanol sulfate

alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol sulfate (2:1) (salt)

Amocasin

API0004123

Asmaven sulfate

Asthavent

AX8292143

BCP0726000244

BG0312

Bis((tert-butyl)(beta,3,4-trihydroxyphenethyl)ammonium) sulphate

bis(salbutamol); sulfuric acid

Broncho Inhalat

Bronchospray

Broncodil

Buventol Easyhaler

C13H21NO3??1/2H2SO4

C13H21NO3.H2O4S

CA0122

CCG-100775

CCG-222402

CHEBI:2550

CHEMBL1201026

CHEMBL1441059

CPD000058513

CTK4J3501

D00683

Dipulmin

dl-Salbutamol sulfate

Eae -Ae

EINECS 256-916-8

Emican

Epaq

EU-0101098

Fartolin

FT-0650809

H886

HMS2051A09

HMS3263K18

HMS3266D17

HMS3393A09

Huma-Salmol

Inspiryl

J10322

K-9412

KS-00000RSS

KS-5056

KSC593K0D

Loftan

LP01098

LS-162604

LS-29862

MFCD00055200

MLS000758199

MLS001423971

MolPort-003-933-916

MolPort-005-933-644

NC00025

NCGC00094370-01

NCGC00261783-01

NSC 289928

NSC-289928

NSC289928

OR076774

OVICLFZZVQVVFT-UHFFFAOYSA-N

Pediavent

Proair HFA

Proair Respiclick

Proventil Repetabs

Proventil Repetabs, Solution, Syrup, and Tablets

Proventil-HFA

Pulvinal salbutamol

S 5013

S0531

s2507

Salbutamol Diskus

Salbutamol Easyhaler

Salbutamol hemisulfate

Salbutamol hemisulfate salt

Salbutamol hemisulfate salt, >=98%

Salbutamol hemisulfate salt, VETRANAL(TM), analytical standard

Salbutamol hemisulphate

Salbutamol sulfate

Salbutamol sulfate - Albuterol

Salbutamol sulfate (Albuterol)

Salbutamol sulfate (JP17)

Salbutamol sulfate for system suitability, European Pharmacopoeia (EP) Reference Standard

Salbutamol sulfate, 99% 1g

Salbutamol sulfate, European Pharmacopoeia (EP) Reference Standard

Salbutamol sulfate(Albuterol)

salbutamol sulphate (albuterol sulphate)

Salbutamol Sulphate (Albuterol Sulphate) 1.0 mg/ml in Methanol (as free base)

salbutamol; sulfuric acid

SAM001246971

SC-18559

Sch 13949W sulfate

SCH-13949W

SCH-13949W Sulfate

SCHEMBL33279

SCHEMBL33280

SMR000058513

TBS-7

TL8003382

Tox21_501098

TQ-1016

Venetlin

Ventolin

Ventolin (TN)

Ventolin easy-breathe

Ventolin HFA

Ventolin Nebules

Ventorlin

Volare

VoSpire ER

Tentative approvals for ALBUTEROL SULFATE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

US Patents and Regulatory Information for albuterol sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pliva	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072317-001	Dec 5, 1989		DISCN	No	No
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-001	Jul 10, 1986		DISCN	No	No
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes					Y
Amneal Pharms	ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	079241-001	May 12, 2010	AA	RX	No	No
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	BX	RX	Yes	Yes					Y
Mylan	ALBUTEROL SULFATE	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	078092-002	Jan 29, 2007	AB	RX	No	No
Warner Chilcott	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072817-001	Jan 9, 1990		DISCN	No	No

Expired US Patents for albuterol sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983
Glaxosmithkline	VENTOLIN	albuterol sulfate	SYRUP;ORAL	019621-001	Jun 10, 1987
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992

International Patents for albuterol sulfate

Country	Document Number	Estimated Expiration
Colombia	4830464
Japan	2000513634
Portugal	1086688
Iceland	5282
Poland	337316
Spain	2258753
Hong Kong	1222812