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AboutPricing
Drug ReportsMontelukast
Montelukast
Montelukast, Singulair (montelukast) is a small molecule pharmaceutical. Montelukast was first approved as Singulair on 1998-02-20. It is used to treat allergic rhinitis perennial and asthma in the USA. The pharmaceutical is active against cysteinyl leukotriene receptor 1. In addition, it is known to target uracil nucleotide/cysteinyl leukotriene receptor.
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YTD
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FDA approval date
EMA approval date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
Trade Name
FDA
EMA
Montelukast, Singulair (discontinued: Montelukast)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Montelukast sodium
Tradename
Company
Number
Date
Products
SINGULAIROrganonN-020829 RX1998-02-20
1 products, RLD, RS
SINGULAIROrganonN-020830 RX1998-02-20
2 products, RLD, RS
SINGULAIROrganonN-021409 RX2002-07-26
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
montelukastANDA2025-08-27
montelukast sodiumANDA2025-08-28
singulairNew Drug Application2025-04-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
allergic rhinitis perennialEFO_1001417D012221J30.89
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03D: Other systemic drugs for obstructive airway diseases in atc
— R03DC: Leukotriene receptor antagonists for obstructive airway diseases
— R03DC03: Montelukast
— R03DC53: Montelukast, combinations
HCPCS
No data
Clinical
Clinical Trials
361 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_0000270J45222113240
Allergic rhinitisD065631—J30.9—1184—23
RhinitisD012220EFO_0008521J31—1183—22
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitis seasonalD006255EFO_0003956J30——11——11
Allergic rhinitis perennialD012221EFO_1001417J30.89——5——5
Exercise-induced asthmaD001250—J45.9901—4——5
BronchiolitisD001988———21—14
Bronchial spasmD001986————2——2
Respiratory signs and symptomsD012818————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory syncytial virus infectionsD018357EFO_1001413—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMontelukast
INNmontelukast
Description
Montelukast is a member of quinolines, a monocarboxylic acid and an aliphatic sulfide. It has a role as a leukotriene antagonist, an anti-asthmatic drug and an anti-arrhythmia drug. It is a conjugate acid of a montelukast(1-).
Classification
Small molecule
Drug classantiasthmatics/antiallergics (not acting primarily as antihistamines): leukotriene receptor antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Identifiers
PDB—
CAS-ID158966-92-8
RxCUI—
ChEMBL IDCHEMBL787
ChEBI ID50730
PubChem CID5281040
DrugBankDB00471
UNII IDMHM278SD3E (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP2C8
CYP2C8
Organism
Homo sapiens
Gene name
CYP2C8
Gene synonyms
NCBI Gene ID
1558
Protein name
cytochrome P450 2C8
Protein synonyms
CYPIIC8, Cytochrome P450 form 1, Cytochrome P450 IIC2, Cytochrome P450 MP-12, Cytochrome P450 MP-20, cytochrome P450, family 2, subfamily C, polypeptide 8, cytochrome P450, subfamily IIC (mephenytoin 4-hydroxylase), polypeptide 8, flavoprotein-linked monooxygenase, microsomal monooxygenase, P450 form 1, S-mephenytoin 4-hydroxylase, xenobiotic monooxygenase
Uniprot ID
Q9UCZ9
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Singulair – Organon
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Singulair – Merck & Co
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Tabular view
Estimated US medical usage
Montelukast
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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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,711 documents
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Safety
Black-box Warning
Black-box warning for: Montelukast, Montelukast sodium, Singulair
Adverse Events
Top Adverse Reactions
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39,999 adverse events reported
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