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Last Updated: May 29, 2020

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VENTOLIN Drug Profile


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

Ventolin is a drug marketed by Glaxosmithkline and is included in seven NDAs. There are three patents protecting this drug.

The generic ingredient in VENTOLIN 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 Ventolin

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

  Start Trial

Drug patent expirations by year for VENTOLIN
Drug Prices for VENTOLIN

See drug prices for VENTOLIN

Drug Sales Revenue Trends for VENTOLIN

See drug sales revenues for VENTOLIN

Recent Clinical Trials for VENTOLIN

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

SponsorPhase
Simbec ResearchPhase 1
AstraZenecaPhase 1
University of Nevada, Las VegasPhase 4

See all VENTOLIN clinical trials

Synonyms for VENTOLIN
.alpha.'-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol
.alpha.1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol
.alpha.1'-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol, hemisulfate
(+-)-Albuterol
(+-)-alpha(sup 1)-(((1,1-Dimethylethyl)amino)methyl)-4-hydroxy-1,3-benzenedimethanol
(+-)-Salbutamol
(alpha1-((tert-butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha-diol)
(l)-albuterol
1-(tert-Butylaminomethyl)-4-hydroxy-m-xylene-.alpha.1,.alpha.3-diol
1-(tert-Butylaminomethyl)-4-hydroxy-m-xylene-alpha1,alpha3-diol
1,3-Benzenedimethanol, .alpha.(1)-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-
1,3-Benzenedimethanol, .alpha.1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-
1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-
1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, (+-)-
1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-
18559-94-9
2-(tert-Butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol
2-(tert-Butylamino)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanol
2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol
35763-26-9
4-(2-(tert-Butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol
4-[(1S)-1-hydroxy-2-(propylamino)ethyl]-2-(hydroxymethyl)phenol, oxamethane
4-[(1S)-2-(butylamino)-1-hydroxy-isopropyl]-2-(hydroxymethyl)phenol
4-[2-(tert-butylamino)-1-hydroxy-ethyl]-2-(hydroxymethyl)phenol
4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol
4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol #
4-[2-(tert-butylamino)-1-oxidanyl-ethyl]-2-(hydroxymethyl)phenol
4-{2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol
4-{2-[(tert-butyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol
4-Hydroxy-3-hydroxymethyl-.alpha.-((tert-butylamino)methyl)benzyl alcohol
4-Hydroxy-3-hydroxymethyl-alpha-((tert-butylamino)methyl)benzyl alcohol
559S949
A812971
AB00052154
AB00052154_10
AB00052154_11
AB00052154-08
AB00052154-09
AB0011383
AB1006817
AC-10286
ACM35763269
Aerolin
AH 3365
AH-3365
Airomir
AKOS007930174
albuterol
ALBUTEROL (+/-)
Albuterol (USP)
Albuterol [USAN:USP]
Albuterol [USAN]
Albuterol, United States Pharmacopeia (USP) Reference Standard
Almotex
alpha-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-alpha,alpha'-diol
alpha'-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol
alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol
Alti-Salbutamol
Anebron
API0006973
Arubendol-Salbutamol
Asmadil
Asmanil
Asmasal
Asmatol
Asmaven
Asmidon
Asmol
Asmol Uni-Dose
Asthalin
AX8136202
BCBcMAP01_000116
BCP28423
BDBM25769
Bio1_000446
Bio1_000935
Bio1_001424
BIS7017
BPBio1_000171
BRD-A88254928-001-04-6
BRD-A88254928-001-05-3
BRN 2213614
Broncho-Spray
Broncovaleas
Bronter
BSPBio_000155
Bugonol
Bumol
Butamol
Buto-Asma
Butohaler
Butotal
Butovent
Buventol
C-14301
CAS-18559-94-9
CC-23825
CCG-39288
CHEBI:2549
CHEMBL714
Cobutolin
Combivent
CS-4556
CS0015
CTK8E5622
D02147
DB01001
Dilatamol
DivK1c_000943
dl-Albuterol
DL-N-tert-Butyl-2-(4-hydroxy-3-hydroxymethylphenyl)-2-hydroxyethylamine
dl-Salbutamol
DSSTox_CID_1255
DSSTox_GSID_21255
DSSTox_RID_76042
DTXSID5021255
EC 242-424-0
EINECS 242-424-0
Eolene
EU-0101090
Farcolin
FT-0630453
Gerivent
Grafalin
GTPL558
HMS1568H17
HMS1921C04
HMS2089I19
HMS2092I08
HMS2095H17
HMS3712H17
HMS502P05
HSDB 7206
HY-B1037
IDI1_000943
J10176
K-5595
KBio1_000943
KBio2_000680
KBio2_003248
KBio2_005816
KBioGR_001294
KBioSS_000680
KS-5209
KSC-11-222-1
KUC106739N
L000531
Levosalbutamol Hydrochloride
Libretin
Lopac0_001090
Lopac0_001098
LS-29861
LS-7693
m-Xylene-.alpha.,.alpha.-diol, .alpha.-1-((tert-butylamino)methyl)-4-hydroxy-
m-Xylene-.alpha.,.alpha.'-diol, .alpha.'-((tert-butylamino)methyl)-4-hydroxy-
m-Xylene-alpha,alpha'-diol, alpha-((tert-butylamino)methyl)-4-hydroxy-
m-Xylene-alpha,alpha'-diol, alpha'-((tert-butylamino)methyl)-4-hydroxy-
MCULE-4493408325
Medolin
MFCD00148978
Mozal
NCGC00015955-04
NCGC00015955-05
NCGC00015955-06
NCGC00015955-07
NCGC00015955-08
NCGC00015955-09
NCGC00015955-10
NCGC00015955-11
NCGC00015955-12
NCGC00015955-13
NCGC00015955-14
NCGC00015955-16
NCGC00024698-02
NCGC00024698-03
NCGC00024698-04
NCGC00024698-05
NCGC00024698-06
NCGC00024698-07
NCGC00258354-01
NDAUXUAQIAJITI-UHFFFAOYSA-N
NINDS_000943
Novosalmol
NSC-757417
NSC757417
Parasma
PDSP1_000623
PDSP2_000620
Pharmakon1600-01500677
Pneumolat
Prestwick_665
Prestwick0_000198
Prestwick1_000198
Prestwick2_000198
Prestwick3_000198
Proventil
Proventil (TN)
Proventil HFA
Proventil Inhaler
Q-201695
Q-201696
Q410358
R,S-Albuterol
racemic salbutamol
Respax
Respolin
S 8260
s5494
Sabutal
Sabutamol
Salamol
Salamol EB
Salbetol
Salbron
Salbu-BASF
Salbu-Fatol
Salbuhexal
Salbulin
Salbupur
Salbusian
Salbutalan
Salbutamol
Salbutamol [INN:BAN]
Salbutamol 100 microg/mL in Acetonitrile
Salbutamol Free Base
Salbutamol impurity I (1RS)-2-[(1,1-dimethylethyl)
Salbutamol sulfate
Salbutamol Sulphate
Salbutamol-d9
Salbutamol, British Pharmacopoeia (BP) Reference Standard
Salbutamol, European Pharmacopoeia (EP) Reference Standard
Salbutamol, VETRANAL(TM), analytical standard
Salbutamol,(+/-)
Salbutamolum
Salbutamolum [INN-Latin]
Salbutan
Salbutol
Salbuven
Salbuvent
Sallbupp
Salmaplon
Salomol
Salvent
Saventol
SBB066105
SBI-0051060.P005
SC-22638
SC-93513
SCH 13949W
SCH-13949W
SCHEMBL10025126
SCHEMBL4913
Servitamol
SGCUT00011
SMP1_000268
Solbutamol
SPBio_001539
SPBio_002076
Spectrum_000200
SPECTRUM1500677
Spectrum2_001350
Spectrum4_000887
Spectrum5_001059
Spreor
SR-01000075161
SR-01000075161-11
SR-01000075161-3
SR-01000075161-4
SR-01000075161-5
SR-01000075161-8
ST024764
ST075204
ST077150
ST24042831
Sultanol
Sultanol N
Suprasma
Suxar
Theosal
to_000081
Tobybron
Tox21_110266
Tox21_110266_1
Tox21_200800
TR-008568
Vencronyl
Venetlin (Salt/Mix)
Ventalin inhaler
Ventamol
Ventilan
Ventiloboi
Ventodisks
Ventolin Inhaler
Ventolin Rotacaps
Ventoline
Volare albuterol HFA
Volare easi-breathe
Volmax
Vospire
VU0243312-5
Zaperin
ZX-AFC000812
Paragraph IV (Patent) Challenges for VENTOLIN
Tradename Dosage Ingredient NDA Submissiondate
VENTOLIN SYRUP;ORAL albuterol sulfate 019621

US Patents and Regulatory Information for VENTOLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline VENTOLIN albuterol AEROSOL, METERED;INHALATION 018473-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate SYRUP;ORAL 019621-001 Jun 10, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate SOLUTION;INHALATION 019773-001 Apr 23, 1992 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate SOLUTION;INHALATION 019269-002 Jan 16, 1987 DISCN No No   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 VENTOLIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VENTOLIN albuterol sulfate SYRUP;ORAL 019621-001 Jun 10, 1987   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol AEROSOL, METERED;INHALATION 018473-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986   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:

Colorcon
McKinsey
Dow
Harvard Business School
Merck
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.