Rhinocort, Duoresp spiromax(budesonide)

Aerosphere, Airsupra, Budesonide/Formoterol Teva Pharma B.V, Entocort, Jorveza, Kinpeygo, Ortikos, 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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Therapeutic Areas

Therapeutic Area	MeSH
digestive system diseases	D004066
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
urogenital diseases	D000091642
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Entocort, Ortikos, Pulmicort, Rhinocort, Tarpeyo, Uceris (generic drugs available since 2008-11-18)

Combinations

Airsupra, Breztri aerosphere, Symbicort, Symbicort aerosphere (generic drugs available since 2008-11-18)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Albuterol sulfate

Budesonide

Tradename	Company	Number	Date	Products
AIRSUPRA	AstraZeneca	N-214070 RX	2023-01-10	1 products, RLD, RS

Budesonide

Tradename	Company	Number	Date	Products
PULMICORT RESPULES	AstraZeneca	N-020929 RX	2000-08-08	3 products, RLD, RS
PULMICORT FLEXHALER	AstraZeneca	N-021949 RX	2006-07-12	2 products, RLD, RS
TARPEYO	Calliditas	N-215935 RX	2021-12-15	1 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, RS
ORTIKOS	Sun Pharmaceutical Industries	N-211929 RX	2019-06-13	2 products, RLD, RS

Show 2 discontinued

Budesonide

Formoterol fumarate

Tradename	Company	Number	Date	Products
SYMBICORT AEROSPHERE	AstraZeneca	N-216579 RX	2023-04-28	1 products, RLD, RS

Budesonide

Formoterol fumarate

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

Labels

FDA

EMA

Brand Name	Status	Last Update
breyna	ANDA	2020-09-24
budesonide inhalation	ANDA	2023-04-24
entocort	New Drug Application	2012-02-07
ortikos	New Drug Application	2020-06-30
pulmicort	New Drug Application	2023-02-04
rhinocort allergy	New Drug Application	2021-01-05
symbicort	New Drug Application	2019-07-24
tarpeyo	New Drug Application	2021-12-21
uceris	New Drug Application	2020-04-23

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
inflammatory bowel diseases	EFO_0003767	D015212	—

Agency Specific

FDA

EMA

Expiration	Code
BUDESONIDE, TARPEYO, CALLIDITAS
2028-12-15	ODE-389
2024-12-15	NP
ALBUTEROL SULFATE / BUDESONIDE, AIRSUPRA, ASTRAZENECA
2026-01-10	NP
BUDESONIDE, BUDESONIDE, PADAGIS ISRAEL
2023-10-24	CGT
BUDESONIDE / FORMOTEROL FUMARATE / GLYCOPYRROLATE, BREZTRI AEROSPHERE, ASTRAZENECA AB
2023-07-23	NC

Patent Expiration

Patent	Expires	Flag	FDA Information
Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab
11331442	2038-05-10	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, Tarpeyo, Calliditas
8491932	2029-05-07	DP	U-3269
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
7759328	2023-01-29	DP	U-2001, U-2002, U-2122
8143239	2023-01-29	DP	U-2001, U-2002, U-2122
8575137	2023-01-29	DP	U-2001, U-2002, U-2122
10166247	2023-01-29	DP	U-2001, U-2002, U-2122
11311558	2023-01-29	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

473 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	23	19	86	43	32	198
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	6	7	19	31	3	66
Eosinophilic esophagitis	D057765	EFO_0004232	K20.0	—	8	6	3	2	18
Healthy volunteers/patients	—			10	—	—	1	3	14
Ulcerative colitis	D003093	EFO_0000729	K51	—	3	8	1	1	12
Respiratory distress syndrome	D012128	EFO_1000637	J80	1	3	2	4	1	10
Bronchopulmonary dysplasia	D001997		P27.8	2	4	3	2	—	9
Allergic rhinitis	D065631		J30.9	1	1	2	2	2	8
Crohn disease	D003424	EFO_0000384	K50	—	1	4	1	1	7
Lung neoplasms	D008175		C34.90	1	3	1	2	—	6

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382		U07.1	1	3	4	—	1	6
Olfaction disorders	D000857		R43.0	1	4	1	—	—	5
Allergic rhinitis seasonal	D006255	EFO_0003956	J30	—	3	2	—	—	5
Sinusitis	D012852	EFO_0007486	J32	—	2	1	—	2	4
Proctitis	D011349	EFO_0005628	K62.89	—	1	3	—	—	4
Collagenous colitis	D046729	EFO_1001293	K52.831	—	—	4	—	—	4
Anosmia	D000086582			1	2	1	—	—	3
Altitude sickness	D000532	EFO_1000782	T70.29	1	—	2	—	—	3
Hypersensitivity	D006967	EFO_0003785	T78.40	1	1	1	—	1	3
Graft vs host disease	D006086		D89.81	1	—	2	—	—	3

Show 20 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bronchiolitis obliterans	D001989	EFO_0007183		—	2	—	—	—	2
Medication adherence	D055118	EFO_0006344		2	2	—	—	—	2
Respiratory tract infections	D012141		J06.9	—	1	—	—	—	1
Interstitial lung diseases	D017563	EFO_0004244	J84.89	—	1	—	—	—	1
Cryptogenic organizing pneumonia	D018549	EFO_1001300	J84.116	—	1	—	—	—	1
Radiation pneumonitis	D017564	EFO_1001411	J70.0	—	1	—	—	—	1
Malnutrition	D044342	EFO_0008572	E40-E46	—	1	—	—	—	1
Breast neoplasms	D001943	EFO_0003869	C50	—	1	—	—	—	1
Esophageal stenosis	D004940		K22.2	—	1	—	—	—	1
Paranasal sinus diseases	D010254			—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Respiratory sounds	D012135	HP_0010307	R06.1	1	—	—	—	3	4
Bronchiolitis	D001988	HP_0011950		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
Precancerous conditions	D011230			1	—	—	—	—	1
Sclerosing cholangitis	D015209	EFO_0004268	K83.01	1	—	—	—	—	1
Pharmacokinetics	D010599			1	—	—	—	—	1
Therapeutic equivalency	D013810			1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Respiratory tract diseases	D012140			—	—	—	—	2	2
Esophageal atresia	D004933	HP_0002032	Q39.0	—	—	—	—	1	1
Personal satisfaction	D010549			—	—	—	—	1	1
Patient satisfaction	D017060			—	—	—	—	1	1
Colitis	D003092	EFO_0003872	K52.9	—	—	—	—	1	1
Non-small-cell lung carcinoma	D002289			—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420		T88.7	—	—	—	—	1	1
Cough	D003371	HP_0012735	R05	—	—	—	—	1	1

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

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

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

Clinical Variant

No data

Financial

Symbicort - AstraZeneca

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Pulmicort - AstraZeneca

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 17,292 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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202 adverse events reported

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MATERIALS

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