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Drug ReportsBudesonide
Rhinocort, Duoresp 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
Entocort, Eohilia, Pulmicort, Rhinocort, Tarpeyo, Uceris (generic drugs available since 2008-11-18, discontinued: Ortikos)
Combinations
Airsupra, Breztri aerosphere, Symbicort, Symbicort aerosphere (generic drugs available since 2008-11-18)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Albuterol sulfate
+
Budesonide
Tradename
Company
Number
Date
Products
AIRSUPRAAstraZenecaN-214070 RX2023-01-10
1 products, RLD, RS
Budesonide
Tradename
Company
Number
Date
Products
PULMICORT RESPULESAstraZenecaN-020929 RX2000-08-08
3 products, RLD, RS
PULMICORT FLEXHALERAstraZenecaN-021949 RX2006-07-12
2 products, RLD, RS
TARPEYOCalliditasN-215935 RX2021-12-15
1 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, RS
EOHILIATakedaN-213976 RX2024-02-09
1 products, RLD, RS
Show 3 discontinued
Budesonide
+
Formoterol fumarate
Tradename
Company
Number
Date
Products
SYMBICORT AEROSPHEREAstraZenecaN-216579 RX2023-04-28
1 products, RLD, RS
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
Labels
FDA
EMA
Brand Name
Status
Last Update
airsupraNew Drug Application2023-01-10
bretzriNew Drug Application2020-07-23
breynaANDA2020-09-24
breztriNew Drug Application2022-01-26
budesonideANDA2024-02-02
budesonide (enteric coated)ANDA2024-01-08
budesonide and formoterol fumarate dihydrateNDA authorized generic2023-03-02
budesonide inhalationANDA2023-12-14
budesonide inhalation suspensionANDA2022-12-16
entocortNew Drug Application2012-02-07
Show 9 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis perennialEFO_1001417D012221J30.89
inflammatory bowel diseasesEFO_0003767D015212—
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
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
Budesonide / Formoterol Fumarate Dihydrate, Symbicort, Astrazeneca
86161962029-04-07DP
85285452028-10-16DP
83876152027-03-26DP
75879882026-04-10DP
88756992024-11-10DP
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
644 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_0000270J452427995769269
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9139273522106
Eosinophilic esophagitisD057765EFO_0004232K20.0—863723
Ulcerative colitisD003093EFO_0000729K51—392215
Healthy volunteers/patients———10——1314
Crohn diseaseD003424EFO_0000384K502252213
Bronchopulmonary dysplasiaD001997—P27.82432110
Respiratory distress syndromeD012128EFO_1000637J801324110
Allergic rhinitisD065631—J30.9112239
Lung neoplasmsD008175HP_0100526C34.90131217
Show 28 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1134—38
Olfaction disordersD000857HP_0000458R43.0141——5
Allergic rhinitis seasonalD006255EFO_0003956J30—32——5
Biliary liver cirrhosisD008105—K74.31—1—24
Graft vs host diseaseD006086—D89.81112——4
ProctitisD011349EFO_0005628K62.89—13——4
Collagenous colitisD046729EFO_1001293K52.831——4——4
Iga glomerulonephritisD005922EFO_0004194——21——3
PneumoniaD011014EFO_0003106———1—23
AnosmiaD000086582——121——3
Show 19 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bronchiolitis obliteransD001989EFO_0007183——2———2
Inflammatory bowel diseasesD015212EFO_0003767——1——12
Medication adherenceD055118EFO_0006344—22———2
Interstitial lung diseasesD017563HP_0006530J84.89—1———1
Cryptogenic organizing pneumoniaD018549EFO_1001300J84.116—1———1
Radiation pneumonitisD017564EFO_1001411J70.0—1———1
MalnutritionD044342EFO_0008572E40-E46—1———1
Severe acute malnutritionD000067011———1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
Esophageal stenosisD004940HP_0010450K22.2—1———1
Show 3 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory soundsD012135HP_0010307R06.11———34
Precancerous conditionsD011230——1———12
Allergic fungal sinusitisD000092562——1————1
BronchiolitisD001988HP_0011950—1————1
Sickle cell anemiaD000755EFO_0000697D571————1
Acute chest syndromeD056586EFO_0007129—1————1
Stem cell transplantationD033581——1————1
Sclerosing cholangitisD015209EFO_0004268K83.011————1
PharmacokineticsD010599——1————1
Therapeutic equivalencyD013810——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory tract diseasesD012140——————22
HemorrhageD006470MP_0001914R58————11
HypertensionD006973EFO_0000537I10————11
MenorrhagiaD008595EFO_0003945N92.0————11
Hemophilia aD006467EFO_0007267D66————11
PainD010146EFO_0003843R52————11
Down syndromeD004314EFO_0001064Q90————11
Mucocutaneous lymph node syndromeD009080EFO_0004246M30.3————11
HyperaldosteronismD006929HP_0011736E26————11
Pulmonary arterial hypertensionD000081029——————11
Show 16 more
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
$
€
£
â‚£
Breztri aerosphere – AstraZeneca
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Symbicort – AstraZeneca
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Pulmicort – AstraZeneca
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Tarpeyo – Calliditas
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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
+
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 19,211 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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57,615 adverse events reported
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