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Drug ReportsFluticasone furoate
Breo ellipta, Avamys(fluticasone furoate)
/ Fluticasone, Advair, Airduo, Avamys, Dymista, Ellipta, Flonase, Flovent, Fluticasone, Fluticasone /, Spiromax, Wixela, Xhance (fluticasone furoate) is a small molecule pharmaceutical. Fluticasone furoate was first approved as Cutivate on 1990-12-14. It is used to treat allergic rhinitis perennial in the USA. It has been approved in Europe to treat allergic rhinitis perennial, allergic rhinitis seasonal, asthma, and chronic obstructive pulmonary disease.
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Events Timeline
5D
1M
3M
6M
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1Y
2Y
5Y
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Arnuity ellipta, Flonase sensimist
Combinations
Breo ellipta, Trelegy ellipta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluticasone furoate
Tradename
Company
Number
Date
Products
ARNUITY ELLIPTAGSKN-205625 RX2014-08-20
3 products, RLD, RS
FLONASE SENSIMIST ALLERGY RELIEFGSKN-022051 OTC2016-08-02
1 products, RLD, RS
Fluticasone furoate
+
Vilanterol trifenatate
Tradename
Company
Number
Date
Products
BREO ELLIPTAGSKN-204275 RX2013-05-10
3 products, RLD, RS
Fluticasone furoate
+
Umeclidinium bromide
+
Vilanterol trifenatate
Tradename
Company
Number
Date
Products
TRELEGY ELLIPTAGSKN-209482 RX2017-09-18
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
24 hour allergy nasalANDA2023-10-11
advairNew Drug Application2023-06-30
advair diskusNew Drug Application2024-01-30
advair hfaNew Drug Application2024-05-23
airduo digihalerNew Drug Application2024-04-29
airduo respiclickNew Drug Application2024-02-06
allergy nasalANDA2024-05-30
allergy reliefANDA2024-10-02
allergy relief nasalANDA2022-11-11
armonair digihalerNew Drug Application2024-04-29
Show 64 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis perennialEFO_1001417D012221J30.89
obstructive sleep apneaEFO_0003918D020181G47.33
chronic bronchitis—D029481J42
pulmonary emphysema—D011656J43
Agency Specific
FDA
EMA
Expiration
Code
FLUTICASONE FUROATE / VILANTEROL TRIFENATATE, BREO ELLIPTA, GLAXO GRP LTD
2026-11-13PED
2026-05-13NPP, NS
FLUTICASONE FUROATE, ARNUITY ELLIPTA, GLAXOSMITHKLINE
2026-03-01M-290
FLUTICASONE PROPIONATE, ARMONAIR DIGIHALER, TEVA PHARM
2025-01-09PED
2024-07-09NPP, NS
FLUTICASONE PROPIONATE, ARMONAIR RESPICLICK, TEVA PHARM
2025-01-09PED
2024-07-09NPP, NS
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO DIGIHALER, TEVA PHARM
2025-01-09PED
2024-07-09M-61
FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE, AIRDUO RESPICLICK, TEVA PHARM
2025-01-09PED
2024-07-09M-61
Patent Expiration
Patent
Expires
Flag
FDA Information
Fluticasone Propionate, Armonair Digihaler, Teva Pharm
112667962041-02-22DP
111732592040-07-06DP
114649232040-06-19DP
114397772040-05-24DP
113446852039-09-26DP
110006532038-12-18DP
113579352038-09-24DP
113513172038-02-10DP
105690342036-08-16DP
109188162035-12-14DP
97825502035-08-28DP
97825512035-08-28DP
87141492032-02-25DP
89789662032-01-13DP
105618082032-01-01DP
92162602031-06-28DP
97310872031-05-18DP
100225102031-05-18DP
101241312031-05-18DP
101953752031-02-14DP
86511032028-03-26DP
94632882025-05-19DP
107658202025-05-19DP
96160242024-09-01DP
Fluticasone Propionate, Xhance, Optinose Us Inc
115542292036-02-23U-2133
103002292035-07-07DPU-2133
100766142034-10-20DP
104785742033-11-04U-2133
101792162033-07-08DPU-2133
110336962033-05-20DP
102520102031-02-07DP
89786472030-12-06DP
85500732029-10-22DP
100766152029-07-30U-2133
116026032028-10-27DPU-2133
101241322027-03-06DPU-2133
79756902025-12-29U-2133
85227782024-04-20DP
Fluticasone Propionate / Salmeterol Xinafoate, Airduo Digihaler, Teva Pharm
90669572034-10-06DPU-645
94150082034-10-06DPU-645
99872292024-09-01DP
Fluticasone Furoate / Umeclidinium Bromide / Vilanterol Trifenatate, Trelegy Ellipta, Glaxosmithkline
97507262030-11-29DP
110902942030-11-29U-3202
85342812030-03-08DP
81619682028-02-05DP
74888272027-12-18DS, DP
85113042027-06-14DPU-1424, U-1691, U-2954, U-3623
81832572025-07-27U-2128, U-2129
74393932025-05-21DS, DPU-1401, U-1691, U-2099, U-2100, U-2127, U-2957, U-3623
74984402025-04-27DS, DP
83095722025-04-27U-2129
Fluticasone Furoate, Arnuity Ellipta, Glaxosmithkline
87462422030-10-11DP
82015562029-02-05DP
93333102027-10-02DP
Fluticasone Furoate / Vilanterol Trifenatate, Breo Ellipta, Glaxo Grp Ltd
111167212029-02-26DPU-1401, U-1691, U-3623
Fluticasone Furoate, Flonase Sensimist Allergy Relief, Haleon Us Holdings
81474612028-10-15DP
83478792028-07-15DP
80622642026-04-05DP
93208622024-11-06DP
Fluticasone Propionate, Flovent Hfa, Glaxo Grp Ltd
75004442026-02-26DP
Azelastine Hydrochloride / Fluticasone Propionate, Dymista, Mylan Speciality Lp
81686202026-02-24DP
ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD12: Fluticasone furoate
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK10: Vilanterol and fluticasone furoate
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL08: Vilanterol, umeclidinium bromide and fluticasone furoate
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BA: Glucocorticoid inhalants for obstructive airway disease
— R03BA09: Fluticasone furoate
HCPCS
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Clinical
Clinical Trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J4554671139863392
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.91818626936201
Lung diseasesD008171HP_0002088J98.4411544422134
Obstructive lung diseasesD008173HP_0006536—411414922125
RhinitisD012220EFO_0008521J31913414219124
Allergic rhinitisD065631—J30.9913374217118
Allergic rhinitis seasonalD006255EFO_0003956J30271912646
Allergic rhinitis perennialD012221EFO_1001417J30.89331611437
Respiratory aspirationD053120EFO_1001839—182104337
Eosinophilic esophagitisD057765EFO_0004232K20.01774622
Show 51 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SinusitisD012852EFO_0007486J32142—510
RhinosinusitisD000096825——142—38
PolypsD011127EFO_0000662—123—27
Bronchiolitis obliteransD001989EFO_0007183——21—25
Bronchiolitis obliterans syndromeD000092122———21—25
AspergillosisD001228EFO_0007157B44—33——3
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.81—33——3
Pulmonary aspergillosisD055732EFO_1001834——33——3
BlisterD001768——2—1——3
PneumoniaD011014EFO_0003106———1—23
Show 17 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Graft vs host diseaseD006086—D89.81—1——12
Medication adherenceD055118EFO_0006344—11——12
Pulmonary eosinophiliaD011657EFO_0007257J82.81—1———1
LeukemiaD007938—C95—1———1
Myelodysplastic syndromesD009190—D46—1———1
Myeloid leukemia acuteD015470—C92.0—1———1
Hematologic neoplasmsD019337———1———1
RecurrenceD012008———1———1
Non-hodgkin lymphomaD008228—C85.9—1———1
Multiple myelomaD009101—C90.0—1———1
Show 13 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD013810——16————16
Diabetes mellitusD003920HP_0000819E08-E132————2
Type 1 diabetes mellitusD003922EFO_0001359E101————1
Knee osteoarthritisD020370EFO_0004616M171————1
OsteoarthritisD010003EFO_0002506M15-M191————1
Liver diseasesD008107HP_0002910K70-K771————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SmokingD012907EFO_0004318—————22
Respiratory signs and symptomsD012818——————22
EmergenciesD004630——————22
Adrenal insufficiencyD000309——————22
Exercise toleranceD017079——————22
FibrosisD005355——————11
Cystic fibrosisD003550EFO_0000390E84————11
Paranasal sinus diseasesD010254——————11
CognitionD003071EFO_0003925—————11
Tobacco use disorderD014029—F17————11
Show 10 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFluticasone furoate
INNfluticasone furoate
Description
Fluticasone furoate is a trifluorinated corticosteroid that consists of 6alpha,9-difluoro-11beta,17alpha-dihydroxy-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-16-methyl-3-oxoandrosta-1,4-diene bearing a 2-furoyl substituent at position 17. Used in combination with vilanterol trifenate for treatment of bronchospasm associated with chronic obstructive pulmonary disease. It has a role as an anti-allergic agent, a prodrug and an anti-asthmatic drug. It is an 11beta-hydroxy steroid, a corticosteroid, a fluorinated steroid, a steroid ester, a 2-furoate ester, a thioester and a 3-oxo-Delta(1),Delta(4)-steroid. It is functionally related to a fluticasone. It derives from a hydride of an androstane.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(OC(=O)c1ccco1)C(=O)SCF
Identifiers
PDB—
CAS-ID397864-44-7
RxCUI—
ChEMBL IDCHEMBL1676
ChEBI ID74899
PubChem CID9854489
DrugBankDB08906
UNII IDJS86977WNV (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
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Dymista – Viatris
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Trelegy ellipta – Innoviva
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Xhance – OptiNose
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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153,029 adverse events reported
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