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Drug ReportsAlbuterol
Albuterol
Airsupra, Albuterol, Combivent, Proair, Proventil, Proventil-hfa, Ventolin (albuterol) is a small molecule pharmaceutical. Albuterol was first approved as Ventolin on 1982-01-01. It is used to treat asthma and bronchial spasm in the USA. The pharmaceutical is active against beta-2 adrenergic receptor.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
immune system diseasesD007154
Trade Name
FDA
EMA
Proair, Proventil-hfa, Ventolin (generic drugs available since 1989-12-05, discontinued: Accuneb, Proventil, Ventolin, Ventolin rotacaps, Volmax, Vospire)
Combinations
Airsupra, Combivent (generic drugs available since 1989-12-05, discontinued: Duoneb)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Albuterol
Tradename
Company
Number
Date
Products
VENTOLINGSKN-018473 DISCN1982-01-01
1 products
PROVENTILMerck Sharp & DohmeN-017559 DISCN1982-01-01
1 products
Hide discontinued
Albuterol sulfate
Tradename
Company
Number
Date
Products
VENTOLIN HFAGSKN-020983 RX2001-04-19
1 products, RLD, RS
PROVENTIL-HFAKindeva Drug DeliveryN-020503 RX1996-08-15
1 products, RLD, RS
PROAIR HFATevaN-021457 RX2004-10-29
1 products, RLD, RS
PROAIR DIGIHALERTevaN-205636 RX2018-12-21
1 products, RLD
PROAIR RESPICLICKTevaN-205636 RX2015-03-31
1 products, RLD, RS
Show 11 discontinued
Albuterol sulfate
+
Budesonide
Tradename
Company
Number
Date
Products
AIRSUPRAAstraZenecaN-214070 RX2023-01-10
1 products, RLD, RS
Albuterol sulfate
+
Ipratropium bromide
Tradename
Company
Number
Date
Products
COMBIVENT RESPIMATBoehringer IngelheimN-021747 RX2011-10-07
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
airsupraNew Drug Application2023-01-10
albuterolANDA2023-11-27
albuterol sulateNDA authorized generic2021-02-17
albuterol sulfateANDA2024-01-31
albuterol sulfate hfaNDA authorized generic2023-02-06
albuterol sulfate inhalation solutionANDA2023-12-20
basic dental emergency kitunapproved drug other2023-03-02
combivent respimatNew Drug Application2023-05-23
deluxe dental emergency kitunapproved drug other2023-03-02
duonebANDA2012-10-26
Show 11 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
bronchial spasm—D001986—
Agency Specific
FDA
EMA
Expiration
Code
ALBUTEROL SULFATE / BUDESONIDE, AIRSUPRA, ASTRAZENECA
2026-01-10NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Albuterol Sulfate, Proair Digihaler, Teva Branded Pharm
112667962041-02-22DP
111732592040-07-06DP
114649232040-06-19DP
114397772040-05-24DP
113446852039-09-26DP
110006532038-12-18DP
113579352038-09-24DP
113513172038-02-10DP
105690342036-08-16DP
109188162035-12-14DP
97825502035-08-28DP
97825512035-08-28DP
89789662032-01-13DP
105618082032-01-01DP
92162602031-06-28DP
97310872031-05-18DP
100225102031-05-18DP
101241312031-05-18DP
86511032028-03-26DP
94632882025-05-19DP
107658202025-05-19DP
Albuterol Sulfate, Proair Hfa, Teva Branded Pharm
94632892031-05-18DP
98085872031-05-18DP
100225092031-05-18DP
100861562031-05-18DP
106955122031-05-18DP
113958892031-05-18DP
81327122028-09-07DP
Albuterol Sulfate / Ipratropium Bromide, Combivent Respimat, Boehringer Ingelheim
87333412030-10-16DP
78372352028-03-13DP
90279672027-03-31DP
73963412026-10-10DP
78962642025-05-26DP
72844742024-08-26DP
Albuterol Sulfate / Budesonide, Airsupra, Astrazeneca
94150092030-05-28U-3509
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AC: Selective beta-2-adrenoreceptor agonist inhalants
— R03AC02: Salbutamol
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK04: Salbutamol and sodium cromoglicate
— R03AK13: Salbutamol and beclometasone
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL02: Salbutamol and ipratropium bromide
— R03C: Adrenergics for systemic use
— R03CC: Selective beta-2-adrenoreceptor agonists, systemic
— R03CC02: Salbutamol
HCPCS
Code
Description
J7607
Levalbuterol, inhalation solution, compounded product, administered through dme, concentrated form, 0.5 mg
J7609
Albuterol, inhalation solution, compounded product, administered through dme, unit dose, 1 mg
J7610
Albuterol, inhalation solution, compounded product, administered through dme, concentrated form, 1 mg
J7611
Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, 1 mg
J7612
Levalbuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, 0.5 mg
J7613
Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 1 mg
J7614
Levalbuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 0.5 mg
J7615
Levalbuterol, inhalation solution, compounded product, administered through dme, unit dose, 0.5 mg
J7620
Albuterol, up to 2.5 mg and ipratropium bromide, up to 0.5 mg, fda-approved final product, non-compounded, administered through dme
Clinical
Clinical Trials
636 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J451652796566276
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9619523343151
Healthy volunteers/patients———91—11223
Status asthmaticusD013224——2543415
BronchiolitisD001988HP_0011950—22—1712
Obstructive lung diseasesD008173HP_0006536——21226
Disease progressionD018450—————246
Lung diseasesD008171HP_0002088J98.41—2126
Exercise-induced asthmaD001250—J45.990——32—5
Heart failureD006333HP_0001635I50—12125
Show 27 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E84——2—911
HypersensitivityD006967HP_0012393T78.40—23—26
Bronchial spasmD001986———21—14
Respiratory distress syndromeD012128EFO_1000637J80211——3
Retinopathy of prematurityD012178EFO_1001158H35.1—21——2
ConjunctivitisD003231HP_0000509H10——2——2
RhinitisD012220EFO_0008521J31——2——2
Transient tachypnea of the newbornD059245—P22.11—1——2
Myasthenia gravisD009157EFO_0004991G70.0—11——1
Pulmonary arterial hypertensionD000081029————1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CoughD003371HP_0012735R05—1——23
Acute lung injuryD055371EFO_0004610——1——12
Pulmonary hypertensionD006976EFO_0001361I27.20—1———1
Familial primary pulmonary hypertensionD065627—I27.0—1———1
LymphangioleiomyomatosisD018192—J84.8111———1
Viral bronchiolitisD001990———1———1
Brain deathD001926—G93.82—1———1
Pulmonary edemaD011654EFO_1001134J81—1———1
Amyotrophic lateral sclerosisD000690HP_0007354G12.21—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920HP_0000819E08-E132————2
Major depressive disorderD003865EFO_0003761F221————1
CicatrixD002921HP_0100699L90.51————1
Sickle cell anemiaD000755EFO_0000697D571————1
Idiopathic pulmonary fibrosisD054990—J84.1121————1
Congenital myasthenic syndromesD020294Orphanet_590G70.21————1
Ciliary motility disordersD002925EFO_0003900—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1————44
SmokingD012907EFO_0004318—————44
EmphysemaD004646EFO_0000464J43————33
PneumoniaD011014EFO_0003106—————22
Cardiovascular diseasesD002318HP_0001626—————22
Airway remodelingD056151——————22
Artificial respirationD012121——————11
Pulmonary atelectasisD001261—J98.1————11
Acute kidney injuryD058186HP_0001919N17————11
Vitamin d deficiencyD014808EFO_0003762E55————11
Show 53 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAlbuterol
INNsalbutamol
Description
Albuterol is a member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). It has a role as a bronchodilator agent, a beta-adrenergic agonist, an environmental contaminant and a xenobiotic. It is a member of phenylethanolamines, a secondary amino compound and a member of phenols.
Classification
Small molecule
Drug classbronchodilators (phenethylamine derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Identifiers
PDB—
CAS-ID18559-94-9
RxCUI—
ChEMBL IDCHEMBL714
ChEBI ID2549
PubChem CID2083
DrugBankDB01001
UNII IDQF8SVZ843E (ChemIDplus, GSRS)
Target
Agency Approved
ADRB2
ADRB2
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
154
Protein name
beta-2 adrenergic receptor
Protein synonyms
adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor
Uniprot ID
Q9UMZ5
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Proair – Teva
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Estimated US medical usage
Albuterol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Albuterol
+
Ipratropium
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 26,372 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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88,859 adverse events reported
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