Albuterol
Accuneb, Airsupra, 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
Trade Name
FDA
EMA
Accuneb, Proair, Proventil-hfa, Ventolin (generic drugs available since 1989-12-05, discontinued: Proventil, Ventolin, Ventolin rotacaps, Volmax, Vospire)
CombinationsAirsupra, 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
Albuterol sulfate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
VENTOLIN HFA | GSK | N-020983 RX | 2001-04-19 | 1 products, RLD, RS |
PROVENTIL-HFA | Kindeva Drug Delivery | N-020503 RX | 1996-08-15 | 1 products, RLD, RS |
ACCUNEB | Mylan | N-020949 RX | 2001-04-30 | 1 products, RLD, RS |
PROAIR HFA | Teva | N-021457 RX | 2004-10-29 | 1 products, RLD, RS |
PROAIR DIGIHALER | Teva | N-205636 RX | 2018-12-21 | 1 products, RLD |
PROAIR RESPICLICK | Teva | N-205636 RX | 2015-03-31 | 1 products, RLD, RS |
Show 11 discontinued
Albuterol sulfate
+
Budesonide
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
AIRSUPRA | AstraZeneca | N-214070 RX | 2023-01-10 | 1 products, RLD, RS |
Albuterol sulfate
+
Ipratropium bromide
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
COMBIVENT RESPIMAT | Boehringer Ingelheim | N-021747 RX | 2011-10-07 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
combivent respimat | New Drug Application | 2022-01-24 |
proair respiclick | New Drug Application | 2023-06-07 |
proventil hfa | New Drug Application | 2021-06-03 |
truemed group llc | Export only | 2022-08-11 |
ventolin | New Drug Application | 2021-08-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
asthma | EFO_0000270 | D001249 | J45 |
bronchial spasm | — | D001986 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
ALBUTEROL SULFATE / BUDESONIDE, AIRSUPRA, ASTRAZENECA | |||
2026-01-10 | NP |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Albuterol Sulfate, Proair Digihaler, Teva Branded Pharm | |||
11266796 | 2041-02-22 | DP | |
11173259 | 2040-07-06 | DP | |
11464923 | 2040-06-19 | DP | |
11439777 | 2040-05-24 | DP | |
11344685 | 2039-09-26 | DP | |
11000653 | 2038-12-18 | DP | |
11357935 | 2038-09-24 | DP | |
11351317 | 2038-02-10 | DP | |
10569034 | 2036-08-16 | DP | |
10918816 | 2035-12-14 | DP | |
9782550 | 2035-08-28 | DP | |
9782551 | 2035-08-28 | DP | |
8978966 | 2032-01-13 | DP | |
10561808 | 2032-01-01 | DP | |
9216260 | 2031-06-28 | DP | |
9731087 | 2031-05-18 | DP | |
10022510 | 2031-05-18 | DP | |
10124131 | 2031-05-18 | DP | |
8651103 | 2028-03-26 | DP | |
9463288 | 2025-05-19 | DP | |
10765820 | 2025-05-19 | DP | |
7540282 | 2023-05-06 | DP | |
Albuterol Sulfate, Proair Hfa, Teva Branded Pharm | |||
9463289 | 2031-05-18 | DP | |
9808587 | 2031-05-18 | DP | |
10022509 | 2031-05-18 | DP | |
10086156 | 2031-05-18 | DP | |
10695512 | 2031-05-18 | DP | |
11395889 | 2031-05-18 | DP | |
8132712 | 2028-09-07 | DP | |
7105152 | 2023-09-12 | DP | |
Albuterol Sulfate / Ipratropium Bromide, Combivent Respimat, Boehringer Ingelheim | |||
8733341 | 2030-10-16 | DP | |
7837235 | 2028-03-13 | DP | |
9027967 | 2027-03-31 | DP | |
7396341 | 2026-10-10 | DP | |
7896264 | 2025-05-26 | DP | |
7284474 | 2024-08-26 | DP | |
Albuterol Sulfate / Budesonide, Airsupra, Astrazeneca | |||
9415009 | 2030-05-28 | U-3509 | |
Albuterol Sulfate, Ventolin Hfa, Glaxosmithkline | |||
7500444 | 2026-02-26 | DP | |
7832351 | 2023-06-19 | DP |
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
387 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Asthma | D001249 | EFO_0000270 | J45 | 12 | 36 | 62 | 48 | 28 | 186 |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 4 | 8 | 24 | 26 | 20 | 82 |
Healthy volunteers/patients | — | 9 | 1 | — | 1 | 5 | 16 | ||
Exercise-induced asthma | D001250 | J45.990 | — | — | 3 | 2 | — | 5 | |
Status asthmaticus | D013224 | 2 | 1 | — | 2 | — | 5 | ||
Disease progression | D018450 | — | — | — | 2 | 1 | 3 | ||
Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | — | 1 | 1 | 3 | |
Hyperkalemia | D006947 | HP_0002153 | E87.5 | — | — | — | 2 | 1 | 3 |
Pediatric obesity | D063766 | — | — | — | 2 | 1 | 3 | ||
Airway obstruction | D000402 | — | — | — | 1 | 2 | 3 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | 1 | — | 2 | 4 |
Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 1 | 3 | — | — | 3 |
Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 2 | — | 1 | 3 |
Bronchial spasm | D001986 | — | 2 | 1 | — | — | 3 | ||
Conjunctivitis | D003231 | H10 | — | — | 2 | — | — | 2 | |
Rhinitis | D012220 | EFO_0008521 | J31 | — | — | 2 | — | — | 2 |
Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | 1 | 1 | — | — | 1 |
Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | 1 | ||
Familial dysautonomia | D004402 | Orphanet_1764 | G90.1 | — | — | 1 | — | — | 1 |
Organophosphate poisoning | D062025 | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Bronchiolitis | D001988 | HP_0011950 | 1 | 1 | — | — | 1 | 3 | |
Cough | D003371 | HP_0012735 | R05 | — | 1 | — | — | 2 | 3 |
Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 1 | — | — | — | 1 |
Familial primary pulmonary hypertension | D065627 | I27.0 | — | 1 | — | — | — | 1 | |
Lymphangioleiomyomatosis | D018192 | J84.81 | 1 | 1 | — | — | — | 1 | |
Viral bronchiolitis | D001990 | — | 1 | — | — | — | 1 | ||
Brain death | D001926 | G93.82 | — | 1 | — | — | — | 1 | |
Pulmonary edema | D011654 | EFO_1001134 | J81 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | — | — | — | — | 2 |
Drug-related side effects and adverse reactions | D064420 | T88.7 | 1 | — | — | — | — | 1 | |
Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | — | 1 |
Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
Idiopathic pulmonary fibrosis | D054990 | J84.112 | 1 | — | — | — | — | 1 | |
Congenital myasthenic syndromes | D020294 | Orphanet_590 | G70.2 | 1 | — | — | — | — | 1 |
Ciliary motility disorders | D002925 | EFO_0003900 | 1 | — | — | — | — | 1 | |
Transient tachypnea of the newborn | D059245 | P22.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 4 | 4 |
Smoking | D012907 | EFO_0003768 | F17 | — | — | — | — | 3 | 3 |
Airway remodeling | D056151 | — | — | — | — | 2 | 2 | ||
Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 1 | 1 |
Viruses | D014780 | NCBITaxon_10239 | STY/T005 | — | — | — | — | 1 | 1 |
Food hypersensitivity | D005512 | EFO_1001890 | — | — | — | — | 1 | 1 | |
Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
Alpha 1-antitrypsin deficiency | D019896 | E88.01 | — | — | — | — | 1 | 1 | |
Argininosuccinic aciduria | D056807 | — | — | — | — | 1 | 1 |
Show 30 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ALBUTEROL |
INN | salbutamol |
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 class | bronchodilators (phenethylamine derivatives) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CC(C)(C)NCC(O)c1ccc(O)c(CO)c1 |
Identifiers
PDB | — |
CAS-ID | 18559-94-9 |
RxCUI | — |
ChEMBL ID | CHEMBL714 |
ChEBI ID | 2549 |
PubChem CID | 2083 |
DrugBank | DB01001 |
UNII ID | QF8SVZ843E (ChemIDplus, GSRS) |
Target
Agency Approved
ADRB2
ADRB2
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
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
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Proair - Teva
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29,649 adverse events reported
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