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Drug ReportsFelbamate
Felbamate
Felbamate, Felbatol (felbamate) is a small molecule pharmaceutical. Felbamate was first approved as Felbatol on 1993-07-29. It is used to treat complex partial epilepsy, epilepsy, lennox gastaut syndrome, and seizures in the USA.
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Financial
Trends
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2Y
5Y
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Events
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
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Felbamate, Felbatol
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Felbamate
Tradename
Company
Number
Date
Products
FELBATOLMylanN-020189 RX1993-07-29
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
felbamateANDA2024-10-24
felbatolNew Drug Application2011-11-14
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX10: Felbamate
HCPCS
No data
Clinical
Clinical Trials
5 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9———123
Intellectual disabilityD008607EFO_0003847F73———1—1
Drug resistant epilepsyD000069279—————1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Central nervous system neoplasmsD016543——11———1
Nervous system neoplasmsD009423——11———1
DepressionD003863—F33.9—1———1
Bipolar disorderD001714EFO_0000289F30.9—1———1
Depressive disorderD003866EFO_1002014F32.A—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Financial stressD000086522——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFelbamate
INNfelbamate
Description
Felbamate is the bis(carbamate ester) of 2-phenylpropane-1,3-diol. An anticonvulsant, it is used in the treatment of epilepsy. It has a role as an anticonvulsant and a neuroprotective agent.
Classification
Small molecule
Drug classtranquilizers/antiepileptics (propanediol and pentanediol groups)
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Structure (InChI/SMILES or Protein Sequence)
NC(=O)OCC(COC(N)=O)c1ccccc1
Identifiers
PDB—
CAS-ID25451-15-4
RxCUI—
ChEMBL IDCHEMBL1094
ChEBI ID4995
PubChem CID3331
DrugBankDB00949
UNII IDX72RBB02N8 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Felbamate
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 1,561 documents
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Safety
Black-box Warning
Black-box warning for: Felbamate, Felbatol
Adverse Events
Top Adverse Reactions
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611 adverse events reported
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