ALBUTEROL SULFATE - Generic Drug Details

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What are the generic drug sources for albuterol sulfate and what is the scope of freedom to operate?

Albuterol sulfate is the generic ingredient in sixteen 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 Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Amneal Pharms Co, Appco, Arise, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Boehringer Ingelheim, Cipla, Fosun Pharma, and Watson Labs Teva, and is included in ninety NDAs. There are thirty-six 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 twelve patent family members in forty-two countries.

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

Summary for ALBUTEROL SULFATE

International Patents:	512
US Patents:	36
Tradenames:	16
Applicants:	45
NDAs:	90
Drug Master File Entries:	38
Suppliers / Packagers:	39
Bulk Api Vendors:	100
Clinical Trials:	26
Patent Applications:	6,235
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ALBUTEROL SULFATE
Drug Sales Revenues:	Drug sales revenues for ALBUTEROL SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE
DailyMed Link:	ALBUTEROL SULFATE at DailyMed

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Drug Sales Revenue Trends for ALBUTEROL SULFATE

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Recent Clinical Trials for ALBUTEROL SULFATE

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

Sponsor	Phase
Sun Pharmaceutical Industries Limited	Phase 3
Amneal Ireland Limited	Phase 3
People's Hospital of Xinjiang Uygur Autonomous Region	N/A

See all ALBUTEROL SULFATE clinical trials

Recent Litigation for ALBUTEROL SULFATE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
MYLAN SPECIALTY L.P. v. AUROBINDO PHARMA USA INC.	2018-10-22
Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc.	2017-03-31
Teva Branded Pharmaceutical Products R&D, Inc. v. Lupin Alantis Holdings SA	2017-03-21

See all ALBUTEROL SULFATE litigation

PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc.	2015-09-29

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Generic filers with tentative approvals for ALBUTEROL SULFATE

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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
(+-)-ysulfate(2:1)(salt)
(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
Aerolin
Aerotec
AH-3365
AKOS015951296
AKOS015994719
Albuterol hemisulfate
Albuterol sulfate (USP)
Albuterol sulfate [USAN:USP]
Albuterol sulfate [USAN]
Albuterol sulfate, Pharmaceutical Secondary Standard; Certified Reference Material
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(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol sulfate (2:1) (salt)
Amocasin
API0004123
Asmaven sulfate
Asthalin
Asthavent
AX8292143
BCP02974
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
OVICLFZZVQVVFT-UHFFFAOYSA-N
Pediavent
ProAir
Proair HFA
Proair Respiclick
Proventil (TN)
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 hemisulfate, 98%
Salbutamol hemisulphate
Salbutamol hemisulphate salt
Salbutamol sulfate
Salbutamol sulfate - Albuterol
Salbutamol sulfate (Albuterol)
Salbutamol sulfate (JP17)
Salbutamol sulfate for system suitability, European Pharmacopoeia (EP) Reference Standard
Salbutamol sulfate, British Pharmacopoeia (BP) Reference Standard
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
Sulbutamol sulphate
TBS-7
TL8003382
Tox21_501098
TQ-1016
Venetlin
Ventolin
Ventolin (TN)
Ventolin easy-breathe
Ventolin HFA
Ventolin Nebules
Ventorlin
Volare
VoSpire ER

Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
PROVENTIL-HFA	AEROSOL, METERED;INHALATION	albuterol sulfate	020503	2015-05-20
PROAIR HFA	AEROSOL, METERED;INHALATION	albuterol sulfate	021457	2012-05-18
ACCUNEB	SOLUTION;INHALATION	albuterol sulfate	020949	2005-10-19
VENTOLIN	SYRUP;ORAL	albuterol sulfate	019621
VOLMAX	TABLET, EXTENDED RELEASE;ORAL	albuterol sulfate	019604

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
Pliva	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072317-001	Dec 5, 1989		DISCN	No	No	Start Trial	Start Trial				Start Trial
Warner Chilcott	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072818-001	Jan 9, 1990		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Schering	PROVENTIL	albuterol sulfate	SYRUP;ORAL	018062-001	Jan 19, 1983		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Dava Pharms Inc	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072860-001	Dec 20, 1989		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teva	ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	073419-001	Mar 30, 1992	AA	RX	No	Yes	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ALBUTEROL SULFATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN	albuterol sulfate	TABLET;ORAL	019112-002	Jul 10, 1986	Start Trial	Start Trial
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	Start Trial	Start Trial
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-001	Jan 14, 1987	Start Trial	Start Trial
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	Start Trial	Start Trial
3m Drug Delivery	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	Start Trial	Start Trial
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	Start Trial	Start Trial
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-002	Dec 23, 1992	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ALBUTEROL SULFATE

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Country	Patent Number	Estimated Expiration
Hong Kong	1222811	Start Trial
Portugal	2314336	Start Trial
China	100413494	Start Trial
Hungary	E042291	Start Trial
Japan	2007521844	Start Trial
China	105903110	Start Trial
Japan	2014140758	Start Trial
>Country	>Patent Number	>Estimated Expiration

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