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formoterol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
bronchodilators, phenethylamine derivatives	1239	73573-87-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: eformoterol formoterol formoterol fumarate formoterol fumarate dihydrate formoterol fumarate hydrate	An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. Molecular weight: 344.41 Formula: C19H24N2O4 CLOGP: 1.26 LIPINSKI: 0 HAC: 6 HDO: 4 TPSA: 90.82 ALOGS: -3.92 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

eformoterol
formoterol
formoterol fumarate
formoterol fumarate dihydrate
formoterol fumarate hydrate

An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

Molecular weight: 344.41
Formula: C19H24N2O4
CLOGP: 1.26
LIPINSKI: 0
HAC: 6
HDO: 4
TPSA: 90.82
ALOGS: -3.92
ROTB: 8

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
24	mcg	Inhal.aerosol
24	mcg	Inhal.powder
0.16	mg	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	8 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.66 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

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Date	Agency	Company
April 28, 2014	EMA	Teva Pharma B.V.
Feb. 16, 2001	FDA	NOVARTIS
June 18, 2019	PMDA	AstraZeneca K.K.

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	802.57	13.41	610	33118	126951	63328343
Product quality issue	611.66	13.41	323	33405	35542	63419752
Dyspnoea	538.76	13.41	1120	32608	660193	62795101
Obstructive airways disorder	403.35	13.41	204	33524	20495	63434799
Wheezing	387.47	13.41	355	33373	95240	63360054
Cough	272.52	13.41	526	33202	292217	63163077
Polycystic ovaries	228.75	13.41	87	33641	4384	63450910
Sleep apnoea syndrome	199.65	13.41	147	33581	28986	63426308
Gastrooesophageal reflux disease	198.16	13.41	249	33479	95390	63359904
Nasal polyps	187.06	13.41	82	33646	5957	63449337

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	483.98	14.27	288	17258	42368	34897017
Product quality issue	405.58	14.27	189	17357	16846	34922539
Dyspnoea	298.62	14.27	610	16936	376172	34563213
Nasal obstruction	170.20	14.27	44	17502	636	34938749
Chronic obstructive pulmonary disease	164.97	14.27	160	17386	48758	34890627
Wheezing	155.97	14.27	144	17402	41258	34898127
Asthma-chronic obstructive pulmonary disease overlap syndrome	150.92	14.27	46	17500	1241	34938144
No adverse event	145.60	14.27	108	17438	22819	34916566
Sinus pain	125.12	14.27	35	17511	692	34938693
Cough	109.51	14.27	236	17310	149904	34789481

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	794.32	12.42	603	38819	134492	79570474
Dyspnoea	560.50	12.42	1273	38149	855752	78849214
Wheezing	387.89	12.42	376	39046	116288	79588678
Obstructive airways disorder	350.04	12.42	209	39213	31250	79673716
Cough	317.39	12.42	613	38809	366176	79338790
Product quality issue	238.43	12.42	169	39253	33771	79671195
Chronic obstructive pulmonary disease	216.27	12.42	238	39184	85181	79619785
Nasal polyps	212.56	12.42	93	39329	7234	79697732
Polycystic ovaries	211.29	12.42	77	39345	3702	79701264
Sleep apnoea syndrome	190.28	12.42	152	39270	36326	79668640

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FDA Adverse Event Reporting System (Pediatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Congenital naevus	27.87	15.89	5	6	70	89711

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Pharmacologic Action:

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Source	Code	Description
ATC	R03AC13	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Selective beta-2-adrenoreceptor agonists
ATC	R03AK07	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK08	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK09	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK11	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AL05	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL07	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL09	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL10	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03AL11	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Pulmonary emphysema	indication	87433001
Non-allergic asthma	indication	266361008	DOID:9360
Severe chronic obstructive pulmonary disease	indication	313299006
Allergic asthma	indication	389145006	DOID:9415
Adjunct Therapy to Achieve Long-term Asthma Control	indication
Exercise-Induced Bronchospasm Prevention	indication
COPD Associated with Chronic Bronchitis	indication
Bronchospasm Prevention with COPD	indication
Mycosis	contraindication	3218000	DOID:1564
Ocular hypertension	contraindication	4210003	DOID:9282

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.23	acidic
pKa2	12.47	acidic
pKa3	8.49	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	10716753	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8324266	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8703806	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8808713	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	9415009	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	9463161	May 28, 2030	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH	BEVESPI AEROSPHERE	ASTRAZENECA	N208294	April 25, 2016	RX	AEROSOL, METERED	INHALATION	8815258	March 17, 2031	USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR REDUCING EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	10166247	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.005MG/INH;0.05MG/INH	DULERA	ORGANON LLC	N022518	Aug. 12, 2019	RX	AEROSOL, METERED	INHALATION	Feb. 12, 2023	PEDIATRIC EXCLUSIVITY
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	July 23, 2023	NEW COMBINATION

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Kd	8.60	CHEMBL	CHEMBL
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	4.89	CHEMBL
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN		Ki	6.50	CHEMBL
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN		EC50	7.60	CHEMBL
Heat shock protein HSP 90-alpha	Cytosolic other	P07900	HS90A_HUMAN		IC50	8.52	WOMBAT-PK
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.79	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_CAVPO		EC50	8.80	CHEMBL

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External reference:

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ID	Source
005421	NDDF
005422	NDDF
016698	NDDF
129490002	SNOMEDCT_US
15056	MMSL
183814-30-4	SECONDARY_CAS_RN
236216	RXNORM
3410	PUBCHEM_CID
3465	IUPHAR_LIGAND_ID
347879	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BEVESPI AEROSPHERE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-4600	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	29 sections
BEVESPI AEROSPHERE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-4600	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	29 sections
BEVESPI AEROSPHERE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-4600	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	29 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7502	AEROSOL, METERED	4.50 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7502	AEROSOL, METERED	4.50 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7503	AEROSOL, METERED	4.50 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
BREYNA	HUMAN PRESCRIPTION DRUG LABEL	2	0378-7503	AEROSOL, METERED	4.50 ug	RESPIRATORY (INHALATION)	ANDA	29 sections
BREZTRI	HUMAN PRESCRIPTION DRUG LABEL	3	0310-4616	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	28 sections
BREZTRI	HUMAN PRESCRIPTION DRUG LABEL	3	0310-4616	AEROSOL, METERED	4.80 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0310-7370	AEROSOL	4.50 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections

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