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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
PERFOROMISTViatrisN-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 Application2025-06-05
foradilNew Drug Application2012-03-01
formoterol fumarateANDA2025-06-05
formoterol fumarate inhalation solutionANDA2025-03-07
Show 6 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory tract diseases—D012140—
asthmaEFO_0000270D001249J45
peptic ulcer—D010437K27
bronchial spasm—D001986—
drug-induced abnormalities—D000014—
inflammatory bowel diseasesEFO_0003767D015212—
allergic rhinitis perennialEFO_1001417D012221J30.89
pruritus—D011537L29
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
113314422038-10-05DP
118332922038-10-05DP
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
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
580 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.981725212595
Obstructive lung diseasesD008173——61324181677
AsthmaD001249EFO_0000270J45—647101174
Lung diseasesD008171EFO_0003818J98.41916121553
EosinophiliaD004802—D72.1———1—1
Pulmonary eosinophiliaD011657EFO_0007257J82.81———1—1
InflammationD007249MP_0001845————1—1
CoughD003371—R05———1—1
Chronic coughD000096822—R05.3———1—1
Cough-variant asthmaD000096823—J45.991———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Exercise-induced asthmaD001250—J45.990—1———1
Bronchiolitis obliteransD001989EFO_0007183J44.81—1———1
BronchiolitisD001988———1———1
Bronchiolitis obliterans syndromeD000092122—D89.811—1———1
Respiratory aspirationD053120EFO_1001839——1———1
Airway obstructionD000402———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Lung neoplasmsD008175—C34.901————1
Precancerous conditionsD011230——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Disease progressionD018450——————11
Chronic diseaseD002908——————11
Retrospective studiesD012189——————11
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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Breztri – AstraZeneca
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Dulera – Organon
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Dulera – Merck & Co
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Symbicort – AstraZeneca
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Breztri aerosphere – AstraZeneca
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Duaklir – AstraZeneca
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Bevespi aerosphere – 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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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Formoterol
Total medical expenditures per year (USD, in millions)
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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 9,928 documents
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Safety
Black-box Warning
Black-box warning for: Foradil
Adverse Events
Top Adverse Reactions
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59,005 adverse events reported
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