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Last Updated: January 20, 2020

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PROVENTIL-HFA Drug Profile

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When do Proventil-hfa patents expire, and when can generic versions of Proventil-hfa launch?

Proventil-hfa is a drug marketed by 3m Drug Delivery and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Proventil-hfa

  Start Trial

A generic version of PROVENTIL-HFA was approved as albuterol sulfate by SUN PHARM INDUSTRIES on January 20th, 2020.

Drug patent expirations by year for PROVENTIL-HFA
Recent Clinical Trials for PROVENTIL-HFA

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

SponsorPhase
West Penn Allegheny Health SystemPhase 4
Asthma Management SystemsPhase 4
Merck Sharp & Dohme Corp.Phase 4

See all PROVENTIL-HFA clinical trials

Recent Litigation for PROVENTIL-HFA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc.2006-05-02

See all PROVENTIL-HFA litigation

Pharmacology for PROVENTIL-HFA
Synonyms for PROVENTIL-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(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)
36519-31-0
4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hemisulfate
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
AC1L22LX
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
bis(salbutamol); sulfuric acid
Broncho Inhalat
Bronchospray
Broncodil
Buventol Easyhaler
C13H21NO3??1/2H2SO4
C13H21NO3.H2O4S
CA0122
CCG-222402
CHEBI:2550
CHEMBL1441059
D00683
Dipulmin
dl-Salbutamol sulfate
Eae -Ae
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
MolPort-003-933-916
NCGC00094370-01
NCGC00261783-01
NSC 289928
Pediavent
ProAir
Proair HFA
Proair Respiclick
Proventil (TN)
Proventil Repetabs
Proventil Repetabs, Solution, Syrup, and Tablets
Pulvinal salbutamol
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
SCHEMBL33279
Sulbutamol sulphate
TBS-7
TL8003382
Tox21_501098
TQ-1016
Venetlin
Ventolin
Ventolin (TN)
Ventolin easy-breathe
Ventolin HFA
Ventolin Nebules
Volare
VoSpire ER
Paragraph IV (Patent) Challenges for PROVENTIL-HFA
Tradename Dosage Ingredient NDA Submissiondate
PROVENTIL-HFA AEROSOL, METERED;INHALATION albuterol sulfate 020503 2015-05-20

US Patents and Regulatory Information for PROVENTIL-HFA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 BX RX Yes 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 PROVENTIL-HFA

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   Start Trial   Start Trial
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996   Start Trial   Start Trial
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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