Foradil, Duoresp spiromax(formoterol)

Aerosphere, Budesonide/Formoterol Teva Pharma B.V, CHF 5993 Chiesi Farmaceutici S.p.A, Duaklir, Duaklir Genuair, Dulera, 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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Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Perforomist (generic drugs available since 2021-06-22, discontinued: Foradil, Foradil certihaler)

Combinations

Bevespi aerosphere, Breztri aerosphere, Duaklir, Dulera, Symbicort, Symbicort aerosphere (generic drugs available since 2021-06-22)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Aclidinium bromide

Formoterol fumarate

Tradename	Company	Number	Date	Products
DUAKLIR PRESSAIR	Covis Pharma	N-210595 RX	2019-03-29	1 products, RLD, RS

Budesonide

Formoterol fumarate

Tradename	Company	Number	Date	Products
SYMBICORT AEROSPHERE	AstraZeneca	N-216579 RX	2023-04-28	1 products, RLD, RS

Budesonide

Formoterol fumarate

Glycopyrrolate

Tradename	Company	Number	Date	Products
BREZTRI AEROSPHERE	AstraZeneca	N-212122 RX	2020-07-23	1 products, RLD, RS

Budesonide

Formoterol fumarate dihydrate

Tradename	Company	Number	Date	Products
SYMBICORT	AstraZeneca	N-021929 RX	2006-07-21	2 products, RLD, RS

Formoterol fumarate

Tradename	Company	Number	Date	Products
PERFOROMIST	Mylan	N-022007 RX	2007-05-11	1 products, RLD, RS

Show 2 discontinued

Formoterol fumarate

Glycopyrrolate

Tradename	Company	Number	Date	Products
BEVESPI AEROSPHERE	AstraZeneca	N-208294 RX	2016-04-25	1 products, RLD, RS

Formoterol fumarate

Mometasone furoate

Tradename	Company	Number	Date	Products
DULERA	Organon	N-022518 RX	2010-06-22	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
bevespi aerosphere	New Drug Application	2020-11-05
breyna	ANDA	2020-09-24
duaklir pressair	New Drug Application	2022-01-25
dulera	New Drug Application	2021-06-01
foradil	New Drug Application	2012-03-01
perforomist	New Drug Application	2019-05-01
symbicort	New Drug Application	2019-07-24

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
asthma	EFO_0000270	D001249	J45
bronchial spasm	—	D001986	—

Agency Specific

FDA

EMA

Expiration	Code
BUDESONIDE / FORMOTEROL FUMARATE / GLYCOPYRROLATE, BREZTRI AEROSPHERE, ASTRAZENECA AB
2023-07-23	NC
FORMOTEROL FUMARATE / MOMETASONE FUROATE, DULERA, ORGANON LLC
2023-02-12	PED

Patent Expiration

Patent	Expires	Flag	FDA Information
Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab
11331442	2038-05-10	DP
8815258	2031-03-17		U-2889
8324266	2030-05-28		U-2889
8703806	2030-05-28		U-2889
8808713	2030-05-28	DP	U-2889
9463161	2030-05-28	DP	U-2889
Budesonide / Formoterol Fumarate, Symbicort Aerosphere, Astrazeneca
9415009	2030-05-28		U-2889, U-3203
10716753	2030-05-28	DP	U-2889, U-3203
Budesonide / Formoterol Fumarate Dihydrate, Symbicort, Astrazeneca
8616196	2029-04-07	DP
8528545	2028-10-16	DP
8387615	2027-03-26	DP
7587988	2026-04-10	DP
8875699	2024-11-10	DP
7759328	2023-01-29	DP	U-2001, U-2002, U-2122
8143239	2023-01-29	DP	U-2001, U-2002, U-2122
8575137	2023-01-29	DP	U-2001, U-2002, U-2122
10166247	2023-01-29	DP	U-2001, U-2002, U-2122
11311558	2023-01-29	DP
Aclidinium Bromide / Formoterol Fumarate, Duaklir Pressair, Covis
10085974	2029-03-13	DP	U-2513
11000517	2029-03-13	DP	U-2513
8051851	2027-04-22	DP
RE46417	2025-02-10	DS, DP	U-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

397 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	18	38	90	33	19	194
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	13	36	61	50	10	166
Emphysema	D004646	EFO_0000464	J43	—	—	4	4	—	8
Disease progression	D018450			—	—	1	3	2	6
Chronic bronchitis	D029481		J42	—	—	2	3	—	5
Bronchiectasis	D001987	HP_0002110	J47	—	—	1	2	1	4
Exercise-induced asthma	D001250		J45.990	—	1	1	1	—	3
Inflammation	D007249			—	1	—	1	—	2
Exercise	D015444	EFO_0000483		—	—	—	1	1	2
Bronchitis	D001991		J40	—	—	1	1	—	2

Show 4 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382		U07.1	—	2	2	—	—	3
Respiratory insufficiency	D012131	HP_0002093	J96.9	—	—	1	—	—	1
Pneumonia	D011014	EFO_0003106	J18	—	—	1	—	—	1
Hypoxia	D000860		R09.02	—	—	1	—	—	1
Hypersensitivity	D006967	EFO_0003785	T78.40	—	1	1	—	—	1
Obstructive lung diseases	D008173	HP_0006536		—	1	1	—	—	1
Smoking	D012907	EFO_0003768	F17	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Medication adherence	D055118	EFO_0006344		2	2	—	—	1	3
Bronchiolitis obliterans	D001989	EFO_0007183		—	2	—	—	—	2
Respiratory tract infections	D012141		J06.9	—	1	—	—	—	1
Interstitial lung diseases	D017563	EFO_0004244	J84.89	—	1	—	—	—	1
Cryptogenic organizing pneumonia	D018549	EFO_1001300	J84.116	—	1	—	—	—	1
Respiratory distress syndrome	D012128	EFO_1000637	J80	—	1	—	—	—	1
Alzheimer disease	D000544	EFO_0000249	F03	—	1	—	—	—	1
Cognitive dysfunction	D060825		G31.84	—	1	—	—	—	1
Airway obstruction	D000402			—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—		4	—	—	—	2	6
Lung neoplasms	D008175	C34.90	1	—	—	—	—	1
Precancerous conditions	D011230		1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Personal satisfaction	D010549			—	—	—	—	1	1
Patient satisfaction	D017060			—	—	—	—	1	1
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	—	—	—	1	1
Bronchial hyperreactivity	D016535			—	—	—	—	1	1
Hypertrophy	D006984	EFO_0002460		—	—	—	—	1	1
Non-small-cell lung carcinoma	D002289			—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420		T88.7	—	—	—	—	1	1
Cough	D003371	HP_0012735	R05	—	—	—	—	1	1
Obesity	D009765	EFO_0001073	E66.9	—	—	—	—	1	1
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	FORMOTEROL
INN	formoterol
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 class	bronchodilators (phenethylamine derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1

Identifiers

PDB	6IBL
CAS-ID	73573-87-2
RxCUI	25255
ChEMBL ID	CHEMBL1256786
ChEBI ID	63082
PubChem CID	3410
DrugBank	DB00983
UNII ID	5ZZ84GCW8B (ChemIDplus, GSRS)

Target

Agency Approved

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

Clinical Variant

No data

Financial

Dulera - Organon

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Dulera - Merck Sharp & Dohme

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Symbicort - AstraZeneca

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Duaklir - AstraZeneca

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 7,135 documents

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Safety

Black-box Warning

Black-box warning for: Foradil

Adverse Events

Top Adverse Reactions

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8,019 adverse events reported

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