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Albuterol sulfate - Generic Drug Details

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, Mova, Teva, Vintage, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Pliva, 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-five NDAs. There are forty-three 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 fifty-five patent family members in forty-four countries.

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

Summary for albuterol sulfate

International Patents:	555
US Patents:	43
Tradenames:	15
Applicants:	40
NDAs:	85
Drug Master File Entries:	38
Suppliers / Packagers:	44
Bulk Api Vendors:	79
Clinical Trials:	871
Patent Applications:	5,798
Formulation / Manufacturing:	see details
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
➤ Sign Up	➤ Sign Up	EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

US Patents and Regulatory Information for albuterol sulfate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072620-001	Dec 5, 1989		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ucb Inc	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	073121-001	Sep 29, 1992		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Hi Tech Pharma	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	074543-001	Jan 15, 1998	AN	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Glaxosmithkline	VENTOLIN ROTACAPS	albuterol sulfate	CAPSULE;INHALATION	019489-001	May 4, 1988		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
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 albuterol sulfate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
3m Drug Delivery	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	➤ Sign Up	➤ Sign Up
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-002	Jul 10, 1986	➤ Sign Up	➤ Sign Up
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992	➤ Sign Up	➤ Sign Up
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-001	Jul 10, 1986	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for albuterol sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
8,157,128	Indicating device	➤ Sign Up
6,743,413	Suspension aerosol formulations	➤ Sign Up
6,655,381	Pre-metered dose magazine for breath-actuated dry powder inhaler	➤ Sign Up
9,526,850	Dose counters for inhalers, inhalers and methods of assembly thereof	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration