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Last Updated: June 4, 2020

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PROAIR HFA Drug Profile


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When do Proair Hfa patents expire, and what generic alternatives are available?

Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. There are eight patents protecting this drug.

This drug has two hundred and forty-one patent family members in twenty-eight countries.

The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Proair Hfa

A generic version of PROAIR HFA was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5th, 1989.

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Drug patent expirations by year for PROAIR HFA
Drug Prices for PROAIR HFA

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Drug Sales Revenue Trends for PROAIR HFA

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Recent Clinical Trials for PROAIR HFA

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SponsorPhase
Sun Pharmaceutical Industries LimitedPhase 3
Amneal Ireland LimitedPhase 3
Oregon Health and Science UniversityPhase 4

See all PROAIR HFA clinical trials

Recent Litigation for PROAIR HFA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Branded Pharmaceutical Products R&D, Inc. v. Lupin Alantis Holdings SA2017-03-21
Teva Branded Pharmaceutical Products R&D Inc. v. Perrigo Pharmaceuticals Co.2013-08-16
ORTHO-MCNEIL PHARMACEUTICAL, INC. v. LUPIN PHARMACEUTICALS, INC.2006-10-17

See all PROAIR HFA litigation

PTAB Litigation
PetitionerDate
2018-10-26

See all PROAIR HFA litigation

Pharmacology for PROAIR HFA
Synonyms for PROAIR HFA
(+-)-Salbutamol sulfate
(+-)-ysulfate(2:1)(salt)
(C13H21NO3)2.H2SO4
022S709
1-(4-Hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate
1,3-Benzenedimethanol, .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
36519-31-0
4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hemisulfate
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
AccuNeb
Accuneb (TN)
Accuvent
Aerotec
AH-3365
AKOS015994719
Albuterol hemisulfate
ALBUTEROL SULFATE
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(2:1)
Aloprol
alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol sulfate (2:1) (salt)
Amocasin
API0004123
BG0312
Bis((tert-butyl)(beta,3,4-trihydroxyphenethyl)ammonium) sulphate
Broncho Inhalat
Bronchospray
Broncodil
Buventol Easyhaler
C13H21NO3??1/2H2SO4
C13H21NO3.H2O4S
CA0122
CCG-222402
CHEBI:2550
CHEMBL1441059
D00683
Dipulmin
dl-Salbutamol sulfate
DTXSID10881180
EINECS 256-916-8
Emican
Epaq
EU-0101098
Fartolin
FT-0650809
H886
HMS3263K18
HMS3266D17
Huma-Salmol
Inspiryl
J10322
K-9412
KS-00000RSS
KS-5056
Loftan
LP01098
LS-162604
LS-29862
NCGC00094370-01
NCGC00261783-01
NSC 289928
NSC-289928
Pediavent
ProAir
Proair Respiclick
Proventil (TN)
Proventil Repetabs
Proventil Repetabs, Solution, Syrup, and Tablets
Proventil-HFA
Pulvinal salbutamol
Q27231480
R03AC02
R03CC02
S 5013
S0531
Salbutamol Diskus
Salbutamol Easyhaler
Salbutamol hemisulfate
Salbutamol hemisulfate salt
Salbutamol hemisulfate salt, >=98%
Salbutamol hemisulfate salt, VETRANAL(TM), analytical standard
Salbutamol sulfate
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 sulphate (albuterol sulphate)
Salbutamol Sulphate (Albuterol Sulphate) 1.0 mg/ml in Methanol (as free base)
SC-18559
Sch 13949W sulfate
SCH-13949W Sulfate
SCHEMBL33279
Sulbutamol sulphate
TBS-7
Tox21_501098
TQ-1016
Venetlin
Ventolin
Ventolin (TN)
Ventolin easy-breathe
Ventolin HFA
Ventolin Nebules
Ventolin Rotacaps
Volare
VoSpire ER
Paragraph IV (Patent) Challenges for PROAIR HFA
Tradename Dosage Ingredient NDA Submissiondate
PROAIR HFA AEROSOL, METERED;INHALATION albuterol sulfate 021457 2012-05-18

US Patents and Regulatory Information for PROAIR HFA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes   Start Trial   Start Trial Y   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 PROAIR HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004   Start Trial   Start Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004   Start Trial   Start Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004   Start Trial   Start Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
McKinsey
Boehringer Ingelheim
McKesson
AstraZeneca

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