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

Stem definition	Drug id	CAS RN
steroids for topical use, acetal derivatives	419	51333-22-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: budesonide barazone budesomide budeson	A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS. Molecular weight: 430.54 Formula: C25H34O6 CLOGP: 2.90 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.06 ALOGS: -3.97 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

budesonide
barazone
budesomide
budeson

A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.

Molecular weight: 430.54
Formula: C25H34O6
CLOGP: 2.90
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.06
ALOGS: -3.97
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
9	mg	O
2	mg	SL
0.20	mg	N
0.80	mg	Inhal.aerosol
0.80	mg	Inhal.powder
1.50	mg	Inhal.solution

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	37 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	3.90 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	20 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.80 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.13 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.09 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.04 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

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Date	Agency	Company
Aug. 1, 2018	EMA	Dr. Falk Pharma GmbH
Feb. 14, 1994	FDA
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	2302.36	10.42	1823	105097	125738	63256364
Wheezing	988.88	10.42	999	105921	94596	63287506
Obstructive airways disorder	772.83	10.42	464	106456	20235	63361867
Dyspnoea	667.50	10.42	2528	104392	658785	62723317
Full blood count abnormal	567.46	10.42	452	106468	31265	63350837
Sleep disorder due to a general medical condition	538.99	10.42	305	106615	11883	63370219
Cough	445.86	10.42	1289	105631	291454	63090648
Macular degeneration	362.19	10.42	312	106608	24064	63358038
Chest discomfort	354.85	10.42	652	106268	109317	63272785
Chronic sinusitis	273.34	10.42	203	106717	12640	63369462

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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	858.84	10.67	644	56643	42012	34857632
Wheezing	427.44	10.67	427	56860	40975	34858669
Dyspnoea	320.33	10.67	1340	55947	375442	34524202
Chronic obstructive pulmonary disease	199.47	10.67	317	56970	48601	34851043
Cough	198.42	10.67	618	56669	149522	34750122
Productive cough	182.41	10.67	265	57022	37548	34862096
Frequent bowel movements	182.31	10.67	158	57129	12629	34887015
Bronchiectasis	162.22	10.67	132	57155	9669	34889975
Colitis ulcerative	151.49	10.67	160	57127	16360	34883284
Chest discomfort	148.24	10.67	296	56991	54234	34845410

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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	2255.48	9.82	1864	135616	133231	79473677
Wheezing	1121.32	9.82	1185	136295	115479	79491429
Dyspnoea	724.06	9.82	3152	134328	853873	78753035
Obstructive airways disorder	678.98	9.82	506	136974	30953	79575955
Full blood count abnormal	594.95	9.82	520	136960	39954	79566954
Cough	540.87	9.82	1621	135859	365168	79241740
Sleep disorder due to a general medical condition	475.03	9.82	300	137180	13977	79592931
Chest discomfort	416.37	9.82	806	136674	137238	79469670
Colitis ulcerative	344.09	9.82	359	137121	34383	79572525
Toxicity to various agents	327.29	9.82	159	137321	421381	79185527

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A07EA06	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Corticosteroids acting locally
ATC	D07AC09	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	R01AD05	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03AK07	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AK12	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC	R03AL11	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03BA02	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:88188	allergenic drug

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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
Crohn's disease	indication	34000006
Allergic rhinitis	indication	61582004
Primary immunoglobulin A nephropathy	indication	68779003
Asthma	indication	195967001	DOID:2841
Eosinophilic esophagitis	indication	235599003	DOID:13922
Severe chronic obstructive pulmonary disease	indication	313299006
Asthma management	indication	406162001
Crohn's disease in remission	indication	426549001
Chronic Non-Allergic Rhinitis	indication
Allergic Rhinitis Prevention	indication

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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	11.8	acidic
pKa2	12.78	acidic

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
0.08MG/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
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	7759328	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	7759328	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	7759328	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8143239	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	8143239	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	8143239	Jan. 29, 2023	USE FOR THE TREATMENT OF ASTHMA IN PATIENTS 6 YEARS OF AGE AND OLDER
0.08MG/INH;0.0045MG/INH	SYMBICORT	ASTRAZENECA	N021929	July 21, 2006	RX	AEROSOL, METERED	INHALATION	8575137	Jan. 29, 2023	USE FOR MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

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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
0.16MG/INH;0.0048MG/INH;0.009MG/INH	BREZTRI AEROSPHERE	ASTRAZENECA AB	N212122	July 23, 2020	RX	AEROSOL, METERED	INHALATION	July 23, 2023	NEW COMBINATION
2MG/ACTUATION	BUDESONIDE	PADAGIS ISRAEL	A215328	April 12, 2023	RX	AEROSOL, FOAM	RECTAL	Oct. 24, 2023	COMPETITIVE GENERIC THERAPY
4MG	TARPEYO	CALLIDITAS	N215935	Dec. 15, 2021	RX	CAPSULE, DELAYED RELEASE	ORAL	Dec. 15, 2024	NEW PRODUCT
4MG	TARPEYO	CALLIDITAS	N215935	Dec. 15, 2021	RX	CAPSULE, DELAYED RELEASE	ORAL	Dec. 15, 2028	TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G
EQ 90MCG BASE/INH;80MCG/INH	AIRSUPRA	ASTRAZENECA	N214070	Jan. 10, 2023	RX	AEROSOL, METERED	INHALATION	Jan. 10, 2026	NEW PRODUCT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	10.30	WOMBAT-PK	CHEMBL
Interleukin-5	Cytokine	P05113	IL5_HUMAN		IC50	9.92	WOMBAT-PK
Interferon gamma	Cytokine	P01579	IFNG_HUMAN		IC50	9.50	WOMBAT-PK
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN	AGONIST	EC50	7.85	IUPHAR
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST	EC50	7.55	IUPHAR
Matrix metalloproteinase-9	Enzyme	P14780	MMP9_HUMAN		IC50	5.70	DRUG MATRIX
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN				WOMBAT-PK
Androgen receptor	Transcription factor		ANDR_RAT		Ki	5.96	DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	7.57	DRUG MATRIX
Glucocorticoid receptor	Transcription factor		GCR_RAT		IC50	8.54	CHEMBL

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External reference:

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ID	Source
004214	NDDF
108622005	SNOMEDCT_US
19831	RXNORM
395726003	SNOMEDCT_US
4020889	VUID
4020889	VANDF
4145	INN_ID
4303	MMSL
44092	MMSL
5281004	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BREZTRI	HUMAN PRESCRIPTION DRUG LABEL	3	0310-4616	AEROSOL, METERED	160 ug	RESPIRATORY (INHALATION)	NDA	28 sections
BREZTRI	HUMAN PRESCRIPTION DRUG LABEL	3	0310-4616	AEROSOL, METERED	160 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6815	SUSPENSION	0.25 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6815	SUSPENSION	0.25 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6816	SUSPENSION	0.50 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6816	SUSPENSION	0.50 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN PRESCRIPTION DRUG LABEL	1	0093-6817	SUSPENSION	1 mg	RESPIRATORY (INHALATION)	ANDA	26 sections
Budesonide	HUMAN OTC DRUG LABEL	1	0363-0048	SPRAY, METERED	32 ug	NASAL	ANDA	15 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0310-7370	AEROSOL	160 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections
Budesonide and Formoterol Fumarate Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0310-7372	AEROSOL	80 ug	RESPIRATORY (INHALATION)	NDA authorized generic	28 sections

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