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Last Updated: January 21, 2020

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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 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.

Drug Prices for ALBUTEROL SULFATE

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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

SponsorPhase
Sun Pharmaceutical Industries LimitedPhase 3
Amneal Ireland LimitedPhase 3
People's Hospital of Xinjiang Uygur Autonomous RegionN/A

See all ALBUTEROL SULFATE clinical trials

Recent Litigation for ALBUTEROL SULFATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
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 SA2017-03-21

See all ALBUTEROL SULFATE litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2015-09-29

See all ALBUTEROL SULFATE litigation

Generic filers with tentative approvals for ALBUTEROL SULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 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
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

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

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

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