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Drug ReportsBenzonatate
Benzonatate
Benzonatate, Tessalon (benzonatate) is a small molecule pharmaceutical. Benzonatate was first approved as Tessalon on 1982-01-01. It is used to treat cough and hiccup in the USA.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Benzonatate, Tessalon (discontinued: Benzonatate, Tessalon)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Benzonatate
Tradename
Company
Number
Date
Products
TESSALONPfizerN-011210 RX1982-01-01
1 products, RLD
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
benzonatateANDA2024-10-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiccupD006606R06.6
coughHP_0012735D003371R05
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
R05: Cough and cold preparations
R05D: Cough suppressants, excl. combinations with expectorants
R05DB: Other cough suppressants in atc
R05DB01: Benzonatate
HCPCS
No data
Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CoughD003371HP_0012735R05213
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBenzonatate
INNbenzonatate
Description
Benzonatate is the ester obtained by formal condensation of 4-butylaminobenzoic acid with nonaethylene glycol monomethyl ether. Structurally related to procaine and benzocaine, it has an anaesthetic effect on the stretch sensors in the lungs, and is used as a non-narcotic cough suppressant. It has a role as an antitussive and an anaesthetic. It is a benzoate ester, a substituted aniline and a secondary amino compound. It is functionally related to a 4-(butylamino)benzoic acid and a nonaethylene glycol monomethyl ether.
Classification
Small molecule
Drug classAntitussives; Local anesthetics; Sodium channel blockers
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Structure (InChI/SMILES or Protein Sequence)
CCCCNc1ccc(C(=O)OCCOCCOCCOCCOCCOCCOCCOCCOCCOC)cc1
Identifiers
PDB
CAS-ID104-31-4
RxCUI
ChEMBL IDCHEMBL1374379
ChEBI ID3032
PubChem CID7699
DrugBankDB00868
UNII ID5P4DHS6ENR (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Benzonatate
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 256 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,380 adverse events reported
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