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Drug ReportsBudesonide
Rhinocort, Biresp spiromax(budesonide)
Aerosphere, Airsupra, Breyna, Budesonide, Budesonide/Formoterol Teva Pharma B.V, Entocort, Eohilia, Jorveza, Kinpeygo, Pulmicort, Rhinocort, Spiromax, Symbicort, Symbicort Aerosphere, Tarpeyo, Uceris (budesonide) is a small molecule pharmaceutical. Budesonide was first approved as Rhinocort on 1994-02-14. It is used to treat allergic rhinitis perennial and inflammatory bowel diseases in the USA. It has been approved in Europe to treat asthma, chronic obstructive pulmonary disease, esophageal diseases, and IGA glomerulonephritis. The pharmaceutical is active against glucocorticoid receptor. In addition, it is known to target progesterone receptor and mineralocorticoid receptor.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
urogenital diseasesD000091642
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Budesonide, Entocort, Eohilia, Pulmicort, Rhinocort, Tarpeyo, Uceris (discontinued: Budesonide, Ortikos, Pulmicort, Rhinocort)
Combinations
Airsupra, Breyna, Breztri aerosphere, Symbicort, Symbicort aerosphere
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Budesonide
Tradename
Company
Number
Date
Products
PULMICORT RESPULESAstraZenecaN-020929 RX2000-08-08
3 products, RLD, RS
TARPEYOCalliditasN-215935 RX2021-12-15
1 products, RLD, RS
PULMICORT FLEXHALERCHEPLAPHARM ArzneimittelN-021949 RX2006-07-12
2 products, RLD, RS
RHINOCORT ALLERGYJohnson & JohnsonN-020746 OTC2015-03-23
1 products, RLD, RS
ENTOCORT ECPadagisN-021324 RX2001-10-02
1 products, RLD, RS
UCERISSalix PharmaceuticalsN-203634 RX2013-01-14
1 products, RLD, RS
UCERISSalix PharmaceuticalsN-205613 RX2014-10-07
1 products, RLD
EOHILIATakedaN-213976 RX2024-02-09
1 products, RLD, RS
Show 3 discontinued
Budesonide
+
Formoterol fumarate
+
Glycopyrrolate
Tradename
Company
Number
Date
Products
BREZTRI AEROSPHEREAstraZenecaN-212122 RX2020-07-23
1 products, RLD, RS
Budesonide
+
Formoterol fumarate dihydrate
Tradename
Company
Number
Date
Products
SYMBICORTAstraZenecaN-021929 RX2006-07-21
2 products, RLD, RS
Albuterol sulfate
+
Budesonide
Tradename
Company
Number
Date
Products
AIRSUPRAAstraZenecaN-214070 RX2023-01-10
1 products, RLD, RS
Budesonide
+
Formoterol fumarate
Tradename
Company
Number
Date
Products
SYMBICORT AEROSPHEREAstraZenecaN-216579 RX2023-04-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
airsupraNew Drug Application2025-09-18
bretzriNew Drug Application2020-07-23
breynaANDA2025-02-27
breztriNew Drug Application2022-01-26
budesonideANDA2025-12-30
budesonide (enteric coated)ANDA2024-01-08
budesonide and formoterol fumarate dihydrateNDA authorized generic2025-11-19
budesonide inhalationANDA2025-06-12
budesonide inhalation suspensionANDA2022-12-16
budesonide nasalANDA2025-12-02
Show 10 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
inflammatory bowel diseasesEFO_0003767D015212—
allergic rhinitis perennialEFO_1001417D012221J30.89
asthmaEFO_0000270D001249J45
bronchial spasm—D001986—
respiratory tract diseases—D012140—
peptic ulcer—D010437K27
drug-induced abnormalities—D000014—
Agency Specific
FDA
EMA
Expiration
Code
BUDESONIDE, TARPEYO, CALLIDITAS
2030-12-20ODE-464
2028-12-15ODE-389
2024-12-15NP
BUDESONIDE, EOHILIA, TAKEDA PHARMS USA
2027-02-09NP
ALBUTEROL SULFATE / BUDESONIDE, AIRSUPRA, ASTRAZENECA
2026-01-10NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Budesonide, Tarpeyo, Calliditas
118967192043-01-23U-3810
121718822043-01-23U-4085, U-4086
121718832043-01-23DP
84919322029-05-07DPU-3269, U-3781
Budesonide, Eohilia, Takeda Pharms Usa
112600642039-01-10DP
115649342039-01-10U-3820
83241922029-08-03U-3820
90503682029-08-01DP
102930522028-11-22DP
113578592028-11-12U-3820
84972582026-11-09U-3820
86795452026-11-09DP
89752432026-11-09U-3820
91198632026-11-09U-3820
111978222026-11-09DP
114132962026-11-09DP
Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab
113314422038-10-05DP
118332922038-10-05DP
88152582031-03-17U-2889
83242662030-05-28U-2889
87038062030-05-28U-2889
88087132030-05-28DPU-2889
94631612030-05-28DPU-2889
Budesonide, Ortikos, Sun Pharm Inds Inc
97071822036-09-09DPU-2554
101728022036-09-09U-2554
Budesonide, Uceris, Salix
88950642031-09-07DP
91320932031-09-07DP
91925812031-09-07DPU-1325
103073752031-09-07DP
106608582031-09-07DP
Albuterol Sulfate / Budesonide, Airsupra, Astrazeneca
94150092030-05-28U-2889, U-3203, U-3509
Budesonide / Formoterol Fumarate, Symbicort Aerosphere, Astrazeneca
107167532030-05-28DPU-2889, U-3203
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA06: Budesonide
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AC: Corticosteroids, potent (group iii)
— D07AC09: Budesonide
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD05: Budesonide
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK07: Formoterol and budesonide
— R03AK12: Salmeterol and budesonide
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL11: Formoterol, glycopyrronium bromide and budesonide
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BA: Glucocorticoid inhalants for obstructive airway disease
— R03BA02: Budesonide
HCPCS
Code
Description
J7626
Budesonide, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, up to 0.5 mg
J7627
Budesonide, inhalation solution, compounded product, administered through dme, unit dose form, up to 0.5 mg
J7633
Budesonide, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, per 0.25 milligram
J7634
Budesonide, inhalation solution, compounded product, administered through dme, concentrated form, per 0.25 milligram
Clinical
Clinical Trials
709 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_0000270J45—5632030118
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.98615192572
Obstructive lung diseasesD008173——541114943
Lung diseasesD008171EFO_0003818J98.41—391225
Allergic rhinitisD065631—J30.9—211—4
RhinitisD012220EFO_0008521J31—211—4
Cough-variant asthmaD000096823—J45.991———112
EosinophiliaD004802—D72.1———1—1
Pulmonary eosinophiliaD011657EFO_0007257J82.81———1—1
InflammationD007249MP_0001845————1—1
Show 7 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ColitisD003092EFO_0003872K52.9—13—14
Exercise-induced asthmaD001250—J45.990—11——2
Eosinophilic esophagitisD057765EFO_0004232K20.0—11—12
EsophagitisD004941HP_0100633K20—11—12
Allergic rhinitis seasonalD006255EFO_0003956J30—11——2
Collagenous colitisD046729EFO_1001293K52.831——2——2
Gastroesophageal refluxD005764EFO_0003948K21—11——1
Peptic esophagitisD004942EFO_1001095——11——1
EmergenciesD004630————1——1
RecurrenceD012008————1——1
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bronchiolitis obliterans syndromeD000092122—D89.811—2———2
Respiration disordersD012120—J00-J99—1———1
Bronchiolitis obliteransD001989EFO_0007183J44.81—1———1
BronchiolitisD001988———1———1
DyspneaD004417—R06.011———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———6————6
Respiratory aspirationD053120EFO_1001839—1————1
Lung neoplasmsD008175—C34.901————1
Precancerous conditionsD011230——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Disease progressionD018450——————11
CoughD003371—R05————11
Microscopic colitisD046728EFO_1001295K52.83————11
Chronic diseaseD002908——————11
Retrospective studiesD012189——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBudesonide
INNbudesonide
Description
Dexbudesonide is a 21-hydroxy steroid.
Classification
Small molecule
Drug classtopical steroids (acetal derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCC1O[C@@H]2C[C@H]3[C@@H]4CCC5=CC(=O)C=C[C@]5(C)[C@H]4[C@@H](O)C[C@]3(C)[C@]2(C(=O)CO)O1
Identifiers
PDB—
CAS-ID51333-22-3
RxCUI—
ChEMBL IDCHEMBL1370
ChEBI ID3207
PubChem CID40000
DrugBankDB01222
UNII IDQ3OKS62Q6X (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
2908
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Q6N0A4
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
PGR
PGR
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
PGR
Gene synonyms
NR3C3
NCBI Gene ID
5241
Protein name
progesterone receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 3
Uniprot ID
Q9UPF7
Mouse ortholog
Pgr (18667)
progesterone receptor (Q00175)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Pulmicort – AstraZeneca
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Tarpeyo – Calliditas
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Airsupra – AstraZeneca
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Breztri aerosphere – AstraZeneca
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Symbicort – AstraZeneca
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Breztri – AstraZeneca
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Tabular view
Estimated US medical usage
Budesonide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Budesonide
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Formoterol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 23,101 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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88,364 adverse events reported
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