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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Commercial
Trade Name
FDA
EMA
Budesonide, Entocort, Eohilia, Pulmicort, Rhinocort, Tarpeyo, Uceris (discontinued: Budesonide, Ortikos, Pulmicort, Rhinocort)
CombinationsAirsupra, 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 RESPULES | AstraZeneca | N-020929 RX | 2000-08-08 | 3 products, RLD, RS |
| TARPEYO | Calliditas | N-215935 RX | 2021-12-15 | 1 products, RLD, RS |
| PULMICORT FLEXHALER | CHEPLAPHARM Arzneimittel | N-021949 RX | 2006-07-12 | 2 products, RLD, RS |
| RHINOCORT ALLERGY | Johnson & Johnson | N-020746 OTC | 2015-03-23 | 1 products, RLD, RS |
| ENTOCORT EC | Padagis | N-021324 RX | 2001-10-02 | 1 products, RLD, RS |
| UCERIS | Salix Pharmaceuticals | N-203634 RX | 2013-01-14 | 1 products, RLD, RS |
| UCERIS | Salix Pharmaceuticals | N-205613 RX | 2014-10-07 | 1 products, RLD |
| EOHILIA | Takeda | N-213976 RX | 2024-02-09 | 1 products, RLD, RS |
Show 3 discontinued
Budesonide
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Formoterol fumarate
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Glycopyrrolate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BREZTRI AEROSPHERE | AstraZeneca | N-212122 RX | 2020-07-23 | 1 products, RLD, RS |
Budesonide
+
Formoterol fumarate dihydrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMBICORT | AstraZeneca | N-021929 RX | 2006-07-21 | 2 products, RLD, RS |
Albuterol sulfate
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Budesonide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AIRSUPRA | AstraZeneca | N-214070 RX | 2023-01-10 | 1 products, RLD, RS |
Budesonide
+
Formoterol fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMBICORT AEROSPHERE | AstraZeneca | N-216579 RX | 2023-04-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| airsupra | New Drug Application | 2024-03-07 |
| bretzri | New Drug Application | 2020-07-23 |
| breyna | ANDA | 2020-09-24 |
| breztri | New Drug Application | 2022-01-26 |
| budesonide | NDA authorized generic | 2024-10-25 |
| budesonide (enteric coated) | ANDA | 2024-01-08 |
| budesonide and formoterol fumarate dihydrate | NDA authorized generic | 2024-10-22 |
| budesonide inhalation | ANDA | 2024-07-30 |
| budesonide inhalation suspension | ANDA | 2022-12-16 |
| entocort | New Drug Application | 2012-02-07 |
Show 10 more
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BUDESONIDE, TARPEYO, CALLIDITAS | |||
| 2030-12-20 | ODE-464 | ||
| 2028-12-15 | ODE-389 | ||
| 2024-12-15 | NP | ||
BUDESONIDE, EOHILIA, TAKEDA PHARMS USA | |||
| 2027-02-09 | NP | ||
ALBUTEROL SULFATE / BUDESONIDE, AIRSUPRA, ASTRAZENECA | |||
| 2026-01-10 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Budesonide, Tarpeyo, Calliditas | |||
| 11896719 | 2043-01-23 | U-3810 | |
| 8491932 | 2029-05-07 | DP | U-3269, U-3781 |
| Budesonide, Eohilia, Takeda Pharms Usa | |||
| 11260064 | 2039-01-10 | DP | |
| 11564934 | 2039-01-10 | U-3820 | |
| 8324192 | 2029-08-03 | U-3820 | |
| 9050368 | 2029-08-01 | DP | |
| 10293052 | 2028-11-22 | DP | |
| 11357859 | 2028-11-12 | U-3820 | |
| 8497258 | 2026-11-09 | U-3820 | |
| 8679545 | 2026-11-09 | DP | |
| 8975243 | 2026-11-09 | U-3820 | |
| 9119863 | 2026-11-09 | U-3820 | |
| 11197822 | 2026-11-09 | DP | |
| 11413296 | 2026-11-09 | DP | |
| Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab | |||
| 11331442 | 2038-10-05 | DP | |
| 11833292 | 2038-10-05 | DP | |
| 8815258 | 2031-03-17 | U-2889 | |
| 8324266 | 2030-05-28 | U-2889 | |
| 8703806 | 2030-05-28 | U-2889 | |
| 8808713 | 2030-05-28 | DP | U-2889 |
| 9463161 | 2030-05-28 | DP | U-2889 |
| Budesonide, Ortikos, Sun Pharm Inds Inc | |||
| 9707182 | 2036-09-09 | DP | U-2554 |
| 10172802 | 2036-09-09 | U-2554 | |
| Budesonide, Uceris, Salix | |||
| 8895064 | 2031-09-07 | DP | |
| 9132093 | 2031-09-07 | DP | |
| 9192581 | 2031-09-07 | DP | U-1325 |
| 10307375 | 2031-09-07 | DP | |
| 10660858 | 2031-09-07 | DP | |
| Albuterol Sulfate / Budesonide, Airsupra, Astrazeneca | |||
| 9415009 | 2030-05-28 | U-2889, U-3203, U-3509 | |
| Budesonide / Formoterol Fumarate, Symbicort Aerosphere, Astrazeneca | |||
| 10716753 | 2030-05-28 | DP | U-2889, U-3203 |
| Budesonide / Formoterol Fumarate Dihydrate, Symbicort, Astrazeneca | |||
| 8616196 | 2029-04-07 | DP | |
| 8528545 | 2028-10-16 | DP | |
| 8387615 | 2027-03-26 | DP | |
| 7587988 | 2026-04-10 | DP | |
| 8875699 | 2024-11-10 | DP | |
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
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 26 | 30 | 107 | 63 | 76 | 295 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 15 | 10 | 30 | 38 | 30 | 122 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 10 | 10 | 24 | 31 | 15 | 90 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 5 | 18 | 26 | 15 | 65 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 5 | 17 | 2 | 3 | 25 |
| Sinusitis | D012852 | EFO_0007486 | J32 | 4 | 7 | 6 | 6 | 6 | 24 |
| Rhinosinusitis | D000096825 | — | — | 6 | 7 | 7 | 5 | 4 | 24 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 8 | 7 | 3 | 7 | 24 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | 8 | 7 | 3 | 7 | 24 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 4 | 4 | 6 | 6 | 21 |
Show 74 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 3 | 2 | — | 3 | 7 |
| Paranasal sinus diseases | D010254 | — | — | — | 4 | 2 | — | 2 | 7 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | 2 | 3 | — | — | 6 |
| Communicable diseases | D003141 | — | — | — | 2 | 2 | — | 2 | 5 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 3 | 2 | — | — | 5 |
| Colorectal neoplasms | D015179 | — | — | 1 | 1 | 3 | — | 1 | 5 |
| Nasopharyngeal neoplasms | D009303 | — | — | 1 | 1 | 3 | — | 1 | 5 |
| Proctitis | D011349 | EFO_0005628 | K62.89 | — | 2 | 3 | — | — | 5 |
| Biliary liver cirrhosis | D008105 | — | K74.3 | 1 | — | 1 | — | 2 | 4 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 4 | 1 | — | — | 4 |
Show 31 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis | D001988 | HP_0011950 | — | 1 | 3 | — | — | — | 4 |
| Bronchiolitis obliterans syndrome | D000092122 | — | — | — | 4 | — | — | — | 4 |
| Bronchiolitis obliterans | D001989 | EFO_0007183 | — | — | 3 | — | — | — | 3 |
| Pathologic constriction | D003251 | — | — | — | 1 | — | — | 1 | 2 |
| Medication adherence | D055118 | EFO_0006344 | — | 2 | 2 | — | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 1 | — | — | — | 1 |
| Intratracheal intubation | D007442 | — | — | 1 | 1 | — | — | — | 1 |
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | — | 1 | — | — | — | 1 |
| Cryptogenic organizing pneumonia | D018549 | EFO_1001300 | J84.116 | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholangitis | D002761 | HP_0030151 | K83.0 | 1 | — | — | — | 1 | 2 |
| Precancerous conditions | D011230 | — | — | 1 | — | — | — | 1 | 2 |
| Allergic fungal sinusitis | D000092562 | — | — | 1 | — | — | — | — | 1 |
| Bronchial hyperreactivity | D016535 | — | — | 1 | — | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
| Acute chest syndrome | D056586 | EFO_0007129 | — | 1 | — | — | — | — | 1 |
| Stem cell transplantation | D033581 | — | — | 1 | — | — | — | — | 1 |
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adrenal insufficiency | D000309 | — | — | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
Show 25 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Budesonide |
| INN | budesonide |
| Description | Dexbudesonide is a 21-hydroxy steroid. |
| Classification | Small molecule |
| Drug class | topical steroids (acetal derivatives) |
| Image (chem structure or protein) |  |
| 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-ID | 51333-22-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1370 |
| ChEBI ID | 3207 |
| PubChem CID | 40000 |
| DrugBank | DB01222 |
| UNII ID | Q3OKS62Q6X (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
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
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Variants
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Pulmicort – AstraZeneca
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Breztri aerosphere – AstraZeneca
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Symbicort – AstraZeneca
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Airsupra – AstraZeneca
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Tarpeyo – Calliditas
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Estimated US medical usage
Budesonide
Total medical expenditures per year (USD, in millions)
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Budesonide
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Formoterol
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Trends
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Safety
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No Black-box warning
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75,960 adverse events reported
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