Ipratropium - PharmaKB

Ipratropium

Atrovent, Combivent, Ipratropium (ipratropium) is a small molecule pharmaceutical. Ipratropium was first approved as Atrovent on 1986-12-29. It is used to treat allergic rhinitis perennial, bronchial spasm, bronchitis, pulmonary emphysema, and vasomotor rhinitis in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M3. In addition, it is known to target muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M1, and muscarinic acetylcholine receptor M4.

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Clinical

Drug

Target

Variants

Financial

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Safety

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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
infections	D007239
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Atrovent, Ipratropium (discontinued: Atrovent, Ipratropium)

Combinations

Albuterol ipratropium, Combivent (discontinued: Albuterol ipratropium, Combivent, Duoneb)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ipratropium bromide

Tradename	Company	Number	Date	Products
ATROVENT HFA	Boehringer Ingelheim	N-021527 RX	2004-11-27	1 products, RLD, RS

Show 4 discontinued

Albuterol sulfate

Ipratropium bromide

Tradename	Company	Number	Date	Products
COMBIVENT RESPIMAT	Boehringer Ingelheim	N-021747 RX	2011-10-07	1 products, RLD, RS

Show 2 discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
albuterol sulfate		2008-09-09
atrovent	New Drug Application	2023-10-05
atrovent hfa		2007-07-26
atroventhfa	New Drug Application	2010-07-28
combivent respimat	New Drug Application	2024-04-15
duoneb	ANDA	2012-10-26
ipratropium bromide	ANDA	2025-01-08
ipratropium bromide and albuterol sulfate	ANDA	2024-12-17
redpharm drug	ANDA	2024-08-15

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
bronchitis	—	D001991	J40
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
pulmonary emphysema	—	D011656	J43
bronchial spasm	—	D001986	—
vasomotor rhinitis	EFO_0007533	D012223	J30.0
asthma	EFO_0000270	D001249	J45

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag
Albuterol Sulfate / Ipratropium Bromide, Combivent Respimat, Boehringer Ingelheim
8733341	2030-10-16	DP
7837235	2028-03-13	DP
9027967	2027-03-31	DP
7396341	2026-10-10	DP
7896264	2025-05-26	DP
7284474	2024-08-26	DP
Ipratropium Bromide, Atrovent Hfa, Boehringer Ingelheim
8474447	2030-01-17	DP

ATC Codes

R: Respiratory system drugs

— R01: Nasal preparations

— R01A: Decongestants and other nasal preparations for topical use

— R01AX: Other nasal preparations in atc

— R01AX03: Ipratropium bromide

— R03: Drugs for obstructive airway diseases

— R03A: Adrenergics, inhalants

— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids

— R03AL01: Fenoterol and ipratropium bromide

— R03AL02: Salbutamol and ipratropium bromide

— R03B: Other drugs for obstructive airway diseases, inhalants in atc

— R03BB: Anticholinergics inhalants for obstructive airway diseases

— R03BB01: Ipratropium bromide

HCPCS

Code	Description
J7620	Albuterol, up to 2.5 mg and ipratropium bromide, up to 0.5 mg, fda-approved final product, non-compounded, administered through dme
J7644	Ipratropium bromide, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per milligram
J7645	Ipratropium bromide, inhalation solution, compounded product, administered through dme, unit dose form, per milligram

Clinical

Clinical Trials

180 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	5	12	27	23	40	107
Lung diseases	D008171	HP_0002088	J98.4	1	11	22	14	25	73
Obstructive lung diseases	D008173	HP_0006536	—	2	9	18	11	32	72
Asthma	D001249	EFO_0000270	J45	2	3	8	14	17	44
Disease progression	D018450	—	—	—	1	2	3	4	10
Respiratory aspiration	D053120	EFO_1001839	—	1	3	—	2	—	5
Dyspnea	D004417	HP_0002094	R06.0	—	—	1	2	2	5
Bronchitis	D001991	—	J40	—	—	—	1	1	2
Acute disease	D000208	—	—	—	—	—	1	1	2
Common cold	D003139	EFO_0007214	J00	—	—	—	1	1	2

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Status asthmaticus	D013224	—	—	2	2	1	—	3	7
Emergencies	D004630	—	—	—	2	2	—	4	7
Retinal diseases	D012164	HP_0000479	H35.9	—	2	1	—	—	2
Premature birth	D047928	EFO_0003917	O60	—	2	1	—	—	2
Retinopathy of prematurity	D012178	EFO_1001158	H35.1	—	2	1	—	—	2
Autonomic nervous system diseases	D001342	EFO_0009532	G90	—	—	1	—	1	2
Hypertension	D006973	EFO_0000537	I10	—	—	1	—	—	1
Pulmonary arterial hypertension	D000081029	—	—	—	—	1	—	—	1
Familial primary pulmonary hypertension	D065627	—	I27.0	—	—	1	—	—	1
Primary dysautonomias	D054969	—	—	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Acute lung injury	D055371	EFO_0004610	—	—	1	—	—	1	2
Lung injury	D055370	—	S27.30	—	1	—	—	1	2
Sialorrhea	D012798	HP_0002307	K11.7	—	1	—	—	1	2
Wounds and injuries	D014947	—	T14.8	—	1	—	—	—	1
Respiratory insufficiency	D012131	HP_0002093	J96.9	—	1	—	—	—	1
Parkinson disease	D010300	EFO_0002508	G20	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	2	—	—	—	1	3
Depression	D003863	—	F33.9	1	—	—	—	—	1
Depressive disorder	D003866	EFO_1002014	F32.A	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
Respiratory sounds	D012135	HP_0010307	R06.1	—	—	—	—	1	1
Obesity	D009765	EFO_0001073	E66.9	—	—	—	—	1	1
Spinal cord injuries	D013119	EFO_1001919	—	—	—	—	—	1	1
Interstitial lung diseases	D017563	HP_0006530	J84.89	—	—	—	—	1	1
Respiratory signs and symptoms	D012818	—	—	—	—	—	—	1	1
Exercise	D015444	EFO_0000483	—	—	—	—	—	1	1
Quadriplegia	D011782	HP_0002510	G82.5	—	—	—	—	1	1
Anesthesia	D000758	—	—	—	—	—	—	1	1
Thoracotomy	D013908	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Ipratropium
INN	ipratropium bromide
Description	Ipratropium bromide is the anhydrous form of the bromide salt of ipratropium. An anticholinergic drug, ipratropium bromide blocks the muscarinic cholinergic receptors in the smooth muscles of the bronchi in the lungs. This opens the bronchi, so providing relief in chronic obstructive pulmonary disease and acute asthma. It has a role as a bronchodilator agent, a muscarinic antagonist and an antispasmodic drug. It contains an ipratropium.
Classification	Small molecule
Drug class	quaternary ammonium derivatives; atropine derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)[N+]1(C)[C@H]2CC[C@@H]1C[C@H](OC(=O)C(CO)c1ccccc1)C2

Identifiers

PDB	—
CAS-ID	60205-81-4
RxCUI	—
ChEMBL ID	CHEMBL1621597
ChEBI ID	—
PubChem CID	657308
DrugBank	DBSALT002739
UNII ID	VJV4X1P2Z1 (ChemIDplus, GSRS)

Target

Agency Approved

CHRM3

Organism

Homo sapiens

Gene name

CHRM3

Gene synonyms

NCBI Gene ID

1131

Protein name

muscarinic acetylcholine receptor M3

Protein synonyms

acetylcholine receptor, muscarinic 3, m3 muscarinic receptor

Uniprot ID

Q9HB60

Mouse ortholog

Chrm3 (12671)

muscarinic acetylcholine receptor M3 (Q9ERZ3)

Alternate

CHRM2

CHRM5

CHRM1

CHRM4

Organism

Homo sapiens

Gene name

CHRM2

Gene synonyms

NCBI Gene ID

1129

Protein name

muscarinic acetylcholine receptor M2

Protein synonyms

7TM receptor, acetylcholine receptor, muscarinic 2, muscarinic M2 receptor

Uniprot ID

Q9P1X9

Mouse ortholog

Chrm2 (243764)

muscarinic acetylcholine receptor M2 (Q9ERZ4)

Variants

No data

Financial

Revenue by drug

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Estimated US medical usage

Ipratropium

Albuterol

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Ipratropium

Total medical expenditures per year (USD, in millions)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 6,102 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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25,255 adverse events reported

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