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Albuterol sulfate - Generic Drug Details

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What are the generic 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, Novitium Pharma, Pliva, Rising Pharms, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Yaopharma Co Ltd, Boehringer Ingelheim, Cipla, Fosun Pharma, and Watson Labs Teva, and is included in eighty-eight NDAs. There are forty-seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has five hundred and sixty-six patent family members in forty-four countries.

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

International Patents:	566
US Patents:	47
Tradenames:	15
Applicants:	43
NDAs:	88
Drug Master File Entries:	38
Suppliers / Packagers:	48
Bulk Api Vendors:	89
Clinical Trials:	24
Patent Applications:	5,905
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
Am Therap	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072449-001	Dec 5, 1989		DISCN	No	No
Glaxosmithkline	VENTOLIN ROTACAPS	albuterol sulfate	CAPSULE;INHALATION	019489-001	May 4, 1988		DISCN	No	No
Rising Pharms	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	207046-002	Jun 29, 2018	AB	RX	No	No
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-001	Jan 14, 1987		DISCN	Yes	No
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	BX	RX	Yes	Yes			Y
Bausch And Lomb	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	075050-001	Jun 18, 1998	AN	RX	No	Yes

Expired US Patents for albuterol sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992
Schering	PROVENTIL	albuterol sulfate	TABLET;ORAL	017853-001	May 7, 1982
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004

International Patents for albuterol sulfate

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011144326
New Zealand	550304
Japan	6301904
Spain	2607956
Cyprus	2539
Denmark	2436414