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Generated: September 24, 2018

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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-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for albuterol sulfate
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
➤ Try a Free Trial➤ Try a Free TrialEQ 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
G And W Labs Inc ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454-001 Sep 25, 1995 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Copley Pharm ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072967-001 Nov 22, 1991 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 BX RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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

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 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-002 Jan 14, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Federal Trade Commission
Chubb
Cipla
Argus Health
Deloitte
UBS
Medtronic
Express Scripts

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