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

Stem definition	Drug id	CAS RN
steroids not used as glucocorticosteroids	1225	80474-14-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fluticasone proprionate fluticasone propionate flixotide fluticasone 17-propionate	A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS. It has received approval to be used in combination with salmeterol. Molecular weight: 500.57 Formula: C25H31F3O5S CLOGP: 4.03 LIPINSKI: 1 HAC: 5 HDO: 1 TPSA: 80.67 ALOGS: -4.64 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fluticasone proprionate
fluticasone propionate
flixotide
fluticasone 17-propionate

A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS. It has received approval to be used in combination with salmeterol.

Molecular weight: 500.57
Formula: C25H31F3O5S
CLOGP: 4.03
LIPINSKI: 1
HAC: 5
HDO: 1
TPSA: 80.67
ALOGS: -4.64
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.20	mg	N
0.60	mg	Inhal.aerosol
0.60	mg	Inhal.powder
1.50	mg	Inhal.solution

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.65 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	6 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	3.60 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	3 %	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	17 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.10 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.00 mg/mL	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

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Date	Agency	Company
Dec. 14, 1990	FDA	FOUGERA PHARMS
June 29, 2020	PMDA	Kyorin Pharmaceutical Co., Ltd.
March 26, 2021	EMA	TEVA B.V.

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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	869.52	10.07	1297	153456	126264	63208005
Synovitis	370.60	10.07	21	154732	186897	63147372
Systemic lupus erythematosus	336.99	10.07	53	154700	208865	63125404
Hand deformity	335.40	10.07	12	154741	159445	63174824
Cough	324.05	10.07	1492	153261	291251	63043018
Completed suicide	320.98	10.07	7	154746	145666	63188603
Contraindicated product administered	317.40	10.07	71	154682	217577	63116692
Wheezing	311.47	10.07	707	154046	94888	63239381
Toxicity to various agents	291.38	10.07	119	154634	247131	63087138
Glossodynia	282.58	10.07	48	154705	178828	63155441

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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	672.23	10.56	606	68926	42050	34845349
Sinusitis	217.86	10.56	335	69197	41067	34846332
Toxicity to various agents	214.66	10.56	66	69466	200296	34687103
Wheezing	210.87	10.56	330	69202	41072	34846327
Infective pulmonary exacerbation of cystic fibrosis	189.21	10.56	135	69397	6666	34880733
Cough	183.39	10.56	685	68847	149455	34737944
Dyspnoea	162.13	10.56	1290	68242	375492	34511907
Eosinophilic granulomatosis with polyangiitis	146.79	10.56	74	69458	1913	34885486
Product dose omission issue	138.47	10.56	537	68995	119174	34768225
Productive cough	130.56	10.56	254	69278	37559	34849840

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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	1106.48	9.68	1415	172060	133680	79437233
Toxicity to various agents	467.22	9.68	167	173308	421373	79149540
Completed suicide	427.77	9.68	27	173448	245740	79325173
Wheezing	394.06	9.68	818	172657	115846	79455067
Cough	387.66	9.68	1702	171773	365087	79205826
Infective pulmonary exacerbation of cystic fibrosis	384.11	9.68	276	173199	12575	79558338
Dyspnoea	332.33	9.68	3075	170400	853950	78716963
Eosinophilic granulomatosis with polyangiitis	278.02	9.68	143	173332	3517	79567396
Synovitis	257.94	9.68	18	173457	150716	79420197
Chest discomfort	248.47	9.68	762	172713	137282	79433631

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	D07AC17	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	R01AD08	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R01AD58	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03AK06	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	R03BA05	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
CHEBI has role	CHEBI:50857	anti-allergic drugs
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35523	bronchodilator

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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
Atopic dermatitis	indication	24079001	DOID:3310
Contact dermatitis	indication	40275004	DOID:2773
Seborrheic dermatitis	indication	50563003	DOID:8741
Lichen simplex chronicus	indication	53891004
Allergic rhinitis	indication	61582004
Granuloma annulare	indication	65508009	DOID:3777
Pulmonary emphysema	indication	87433001
Pruritus ani	indication	90446007
Discoid lupus erythematosus	indication	200938002
Plaque psoriasis	indication	200965009

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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	11.49	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
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	9066957	Oct. 6, 2034	TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	9415008	Oct. 6, 2034	TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	9415008	Oct. 6, 2034	TREATMENT OF ASTHMA
0.093MG	XHANCE	OPTINOSE US INC	N209022	Sept. 18, 2017	RX	SPRAY, METERED	NASAL	8327844	Oct. 24, 2023	METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG	XHANCE	OPTINOSE US INC	N209022	Sept. 18, 2017	RX	SPRAY, METERED	NASAL	7975690	Dec. 29, 2025	METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG	XHANCE	OPTINOSE US INC	N209022	Sept. 18, 2017	RX	SPRAY, METERED	NASAL	10124132	March 6, 2027	METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG	XHANCE	OPTINOSE US INC	N209022	Sept. 18, 2017	RX	SPRAY, METERED	NASAL	11602603	Oct. 27, 2028	METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG	XHANCE	OPTINOSE US INC	N209022	Sept. 18, 2017	RX	SPRAY, METERED	NASAL	10076615	July 30, 2029	METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY
0.093MG	XHANCE	OPTINOSE US INC	N209022	Sept. 18, 2017	RX	SPRAY, METERED	NASAL	10179216	July 8, 2033	METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY

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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
0.03MG/INH	ARMONAIR RESPICLICK	TEVA PHARM	N208798	July 9, 2021	DISCN	POWDER	INHALATION	July 9, 2024	NEW STRENGTH
0.03MG/INH	ARMONAIR RESPICLICK	TEVA PHARM	N208798	July 9, 2021	DISCN	POWDER	INHALATION	Jan. 9, 2025	PEDIATRIC EXCLUSIVITY
0.055MG/INH	ARMONAIR DIGIHALER	TEVA PHARM	N208798	Feb. 20, 2020	RX	POWDER	INHALATION	July 9, 2024	NEW PATIENT POPULATION
0.055MG/INH	ARMONAIR RESPICLICK	TEVA PHARM	N208798	Jan. 27, 2017	DISCN	POWDER	INHALATION	July 9, 2024	NEW PATIENT POPULATION
0.055MG/INH	ARMONAIR DIGIHALER	TEVA PHARM	N208798	Feb. 20, 2020	RX	POWDER	INHALATION	Jan. 9, 2025	PEDIATRIC EXCLUSIVITY
0.055MG/INH	ARMONAIR RESPICLICK	TEVA PHARM	N208798	Jan. 27, 2017	DISCN	POWDER	INHALATION	Jan. 9, 2025	PEDIATRIC EXCLUSIVITY
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	July 9, 2024	REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	July 9, 2024	REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO DIGIHALER	TEVA PHARM	N208799	July 12, 2019	RX	POWDER	INHALATION	Jan. 9, 2025	PEDIATRIC EXCLUSIVITY
0.055MG/INH;EQ 0.014MG BASE/INH	AIRDUO RESPICLICK	TEVA PHARM	N208799	Jan. 27, 2017	RX	POWDER	INHALATION	Jan. 9, 2025	PEDIATRIC EXCLUSIVITY

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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	10.74	WOMBAT-PK	CHEMBL
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN	AGONIST	EC50	6.83	IUPHAR
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN	AGONIST	EC50	9.77	WOMBAT-PK
Cytosolic phospholipase A2	Enzyme	P47712	PA24A_HUMAN				WOMBAT-PK
Glucocorticoid receptor	Transcription factor		GCR_RAT		EC50	9.12	CHEMBL

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External reference:

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ID	Source
003593	NDDF
004952	NDDF
108632003	SNOMEDCT_US
396064000	SNOMEDCT_US
397192001	SNOMEDCT_US
4020180	VUID
4020180	VANDF
4020529	VANDF
41126	RXNORM
444036	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
basic care allergy relief nasal	HUMAN OTC DRUG LABEL	1	0113-7117	SPRAY, METERED	50 ug	NASAL	ANDA	17 sections
DYMISTA	HUMAN PRESCRIPTION DRUG LABEL	2	0037-0245	SPRAY, METERED	50 ug	NASAL	NDA	29 sections
DYMISTA	HUMAN PRESCRIPTION DRUG LABEL	2	0037-0245	SPRAY, METERED	50 ug	NASAL	NDA	29 sections
FLONASEALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	0135-0576	SPRAY, METERED	50 ug	NASAL	NDA	16 sections
FLONASEALLERGY RELIEF	HUMAN OTC DRUG LABEL	1	0135-0576	SPRAY, METERED	50 ug	NASAL	NDA	16 sections
Fluticasone Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3270	SPRAY, METERED	50 ug	NASAL	ANDA	26 sections
Fluticasone Propionate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3270	SPRAY, METERED	50 ug	NASAL	ANDA	26 sections
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0326	POWDER	100 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0326	POWDER	100 ug	RESPIRATORY (INHALATION)	ANDA	28 sections
fluticasone propionate and salmeterol	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0327	POWDER	250 ug	RESPIRATORY (INHALATION)	ANDA	28 sections

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