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Drug ReportsFormoterol
Foradil, Duoresp spiromax(formoterol)
Aerosphere, Breyna, Budesonide/Formoterol Teva Pharma B.V, CHF 5993 Chiesi Farmaceutici S.p.A, Duaklir, Duaklir Genuair, Dulera, Formoterol, Genuair, Perforomist, Riarify, Spiromax, Symbicort, Symbicort Aerosphere, Trimbow, Trydonis (formoterol) is a small molecule pharmaceutical. Formoterol was first approved as Foradil on 2001-02-16. It is used to treat asthma and bronchial spasm in the USA. It has been approved in Europe to treat asthma and chronic obstructive pulmonary disease. 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
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Formoterol, Perforomist (discontinued: Foradil, Foradil certihaler)
Combinations
Bevespi aerosphere, Breyna, Breztri aerosphere, Duaklir, Dulera, Symbicort, Symbicort aerosphere
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Formoterol fumarate
+
Glycopyrrolate
Tradename
Company
Number
Date
Products
BEVESPI AEROSPHEREAstraZenecaN-208294 RX2016-04-25
1 products, RLD, RS
Budesonide
+
Formoterol fumarate
+
Glycopyrrolate
Tradename
Company
Number
Date
Products
BREZTRI AEROSPHEREAstraZenecaN-212122 RX2020-07-23
1 products, RLD, RS
Formoterol fumarate
+
Mometasone furoate
Tradename
Company
Number
Date
Products
DULERAOrganonN-022518 RX2010-06-22
3 products, RLD, RS
Budesonide
+
Formoterol fumarate dihydrate
Tradename
Company
Number
Date
Products
SYMBICORTAstraZenecaN-021929 RX2006-07-21
2 products, RLD, RS
Budesonide
+
Formoterol fumarate
Tradename
Company
Number
Date
Products
SYMBICORT AEROSPHEREAstraZenecaN-216579 RX2023-04-28
1 products, RLD, RS
Aclidinium bromide
+
Formoterol fumarate
Tradename
Company
Number
Date
Products
DUAKLIR PRESSAIRCovis PharmaN-210595 RX2019-03-29
1 products, RLD, RS
Formoterol fumarate
Tradename
Company
Number
Date
Products
PERFOROMISTMylanN-022007 RX2007-05-11
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bevespi aerosphereNew Drug Application2023-03-24
bretzriNew Drug Application2020-07-23
breynaANDA2020-09-24
breztriNew Drug Application2022-01-26
budesonide and formoterol fumarate dihydrateNDA authorized generic2024-10-22
duaklir pressairNew Drug Application2022-08-01
duleraNew Drug Application2023-03-24
foradilNew Drug Application2012-03-01
formoterol fumarateANDA2024-11-07
formoterol fumarate inhalation solution and pari lc plus nebulizerANDA2024-10-10
Show 1 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory tract diseases—D012140—
asthmaEFO_0000270D001249J45
peptic ulcerHP_0004398D010437K27
bronchial spasm—D001986—
drug-induced abnormalities—D000014—
inflammatory bowel diseasesEFO_0003767D015212—
allergic rhinitis perennialEFO_1001417D012221J30.89
pruritusHP_0000989D011537L29
inflammationMP_0001845D007249—
facial dermatoses—D005148—
Show 5 more
Agency Specific
FDA
EMA
Expiration
Code
BUDESONIDE / FORMOTEROL FUMARATE / GLYCOPYRROLATE, BREZTRI AEROSPHERE, ASTRAZENECA AB
2023-07-23NC
FORMOTEROL FUMARATE / MOMETASONE FUROATE, DULERA, ORGANON LLC
2023-02-12PED
Patent Expiration
Patent
Expires
Flag
FDA Information
Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab
113314422038-05-10DP
88152582031-03-17U-2889
83242662030-05-28U-2889
87038062030-05-28U-2889
88087132030-05-28DPU-2889
94631612030-05-28DPU-2889
Budesonide / Formoterol Fumarate, Symbicort Aerosphere, Astrazeneca
94150092030-05-28U-2889, U-3203
107167532030-05-28DPU-2889, U-3203
Budesonide / Formoterol Fumarate Dihydrate, Symbicort, Astrazeneca
86161962029-04-07DP
85285452028-10-16DP
83876152027-03-26DP
75879882026-04-10DP
88756992024-11-10DP
77593282023-01-29DPU-2001, U-2002, U-2122
81432392023-01-29DPU-2001, U-2002, U-2122
85751372023-01-29DPU-2001, U-2002, U-2122
101662472023-01-29DPU-2001, U-2002, U-2122
113115582023-01-29DP
Aclidinium Bromide / Formoterol Fumarate, Duaklir Pressair, Covis
100859742029-03-13DPU-2513
110005172029-03-13DPU-2513
80518512027-04-22DP
RE464172025-02-10DS, DPU-2513
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AC: Selective beta-2-adrenoreceptor agonist inhalants
— R03AC13: Formoterol
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK07: Formoterol and budesonide
— R03AK08: Formoterol and beclometasone
— R03AK09: Formoterol and mometasone
— R03AK11: Formoterol and fluticasone
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL05: Formoterol and aclidinium bromide
— R03AL07: Formoterol and glycopyrronium bromide
— R03AL09: Formoterol, glycopyrronium bromide and beclometasone
— R03AL10: Formoterol and tiotropium bromide
— R03AL11: Formoterol, glycopyrronium bromide and budesonide
— R03C: Adrenergics for systemic use
— R03CC: Selective beta-2-adrenoreceptor agonists, systemic
— R03CC15: Formoterol
HCPCS
Code
Description
J7605
Arformoterol, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 15 micrograms
J7606
Formoterol fumarate, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 20 micrograms
J7640
Formoterol, inhalation solution, compounded product, administered through dme, unit dose form, 12 micrograms
Clinical
Clinical Trials
588 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_0000270J4523501145060289
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.92447886145257
Obstructive lung diseasesD008173HP_0006536—1433664529183
Lung diseasesD008171HP_0002088J98.4229553722141
EmphysemaD004646EFO_0000464J43——45—9
BronchitisD001991—J40——35—8
Disease progressionD018450————1337
CoughD003371HP_0012735R0511—146
Cough-variant asthmaD000096823——11—326
Pulmonary emphysemaD011656—J43——24—6
Show 22 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory aspirationD053120EFO_1001839—331—17
AspergillosisD001228EFO_0007157B44—44——4
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.81—44——4
Pulmonary aspergillosisD055732EFO_1001834——44——4
Covid-19D000086382———22——3
InfectionsD007239EFO_0000544——11——2
Communicable diseasesD003141———11——2
Respiratory insufficiencyD012131HP_0002093J96.9——2——2
PneumoniaD011014EFO_0003106———1——1
RecurrenceD012008————1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bronchiolitis obliteransD001989EFO_0007183——3———3
BronchiolitisD001988HP_0011950——3———3
Bronchiolitis obliterans syndromeD000092122———3———3
Medication adherenceD055118EFO_0006344—22——13
Interstitial lung diseasesD017563HP_0006530J84.89—1———1
Cryptogenic organizing pneumoniaD018549EFO_1001300J84.116—1———1
Organizing pneumoniaD000092124———1———1
Respiratory distress syndromeD012128EFO_1000637J80—1———1
Acute lung injuryD055371EFO_0004610——1———1
Lung injuryD055370—S27.30—1———1
Show 10 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———8———210
Lung neoplasmsD008175HP_0100526C34.901————1
Precancerous conditionsD011230——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitisD065631—J30.9————22
RhinitisD012220EFO_0008521J31————22
Chronic coughD000096822——————22
Personal satisfactionD010549——————11
Patient satisfactionD017060——————11
Type 1 diabetes mellitusD003922EFO_0001359E10————11
HypoglycemiaD007003HP_0001943E16.2————11
Bronchial hyperreactivityD016535——————11
HypertrophyD006984EFO_0002460—————11
Non-small-cell lung carcinomaD002289——————11
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFormoterol
INNformoterol
Description
N-[2-hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethyl)phenyl]formamide is a phenylethanoloamine having 4-hydroxy and 3-formamido substituents on the phenyl ring and an N-(4-methoxyphenyl)propan-2-yl substituent. It is a member of phenols, a member of formamides, a secondary amino compound, a secondary alcohol and a member of phenylethanolamines.
Classification
Small molecule
Drug classbronchodilators (phenethylamine derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1
Identifiers
PDB—
CAS-ID73573-87-2
RxCUI—
ChEMBL IDCHEMBL1256786
ChEBI ID63082
PubChem CID3410
DrugBankDB00983
UNII ID5ZZ84GCW8B (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
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Bevespi aerosphere – AstraZeneca
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Dulera – Organon
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Dulera – Merck & Co
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Breztri aerosphere – AstraZeneca
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Symbicort – AstraZeneca
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Duaklir – AstraZeneca
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Tabular view
Estimated US medical usage
Formoterol
+
Budesonide
Total medical expenditures per year (USD, in millions)
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Formoterol
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Formoterol
+
Mometasone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,251 documents
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Safety
Black-box Warning
Black-box warning for: Foradil
Adverse Events
Top Adverse Reactions
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66,669 adverse events reported
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