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Aptiom, Exalief(eslicarbazepine acetate)
Aptiom, Zebinix (eslicarbazepine acetate) is a small molecule pharmaceutical. Eslicarbazepine acetate was first approved as Exalief on 2009-04-21. It has been approved in Europe to treat epilepsy.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
Trade Name
FDA
EMA
Aptiom (generic drugs available since 2021-06-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eslicarbazepine acetate
Tradename
Company
Number
Date
Products
APTIOMSunovion PharmaceuticalsN-022416 RX2013-11-08
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
aptiomNew Drug Application2020-11-24
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Eslicarbazepine Acetate, Aptiom, Sunovion Pharms Inc
97507472032-08-24U-2041, U-2121
83724312030-04-17DP
95662442028-10-23DP
109127812028-10-23DP
97639542028-09-13U-2123
92061352026-04-21DP
96439292026-04-21DP
106752872025-05-06U-2041, U-2831
106953542025-05-06U-2501, U-2831
107025362025-05-06U-2501
113642472025-05-06U-2501, U-2831
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AF: Carboxamide derivatives, antiepileptics
— N03AF04: Eslicarbazepine
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.928272241
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Partial epilepsiesD004828EFO_0004263214——7
Diabetic neuropathiesD003929EFO_1000783—11——2
Postherpetic neuralgiaD051474—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bipolar disorderD001714EFO_0000289F30.9—3———3
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuralgiaD009437EFO_00094301————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AgingD000375GO_0007568R41.81————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameESLICARBAZEPINE ACETATE
INNeslicarbazepine
Description
Eslicarbazepine acetate is the acetate ester, with S configuration, of licarbazepine. An anticonvulsant, it is approved for use in Europe and the United States as an adjunctive therapy for epilepsy. It has a role as an anticonvulsant and a drug allergen. It is an acetate ester, a dibenzoazepine, a carboxamide and a member of ureas. It is functionally related to a licarbazepine.
Classification
Small molecule
Drug classtricyclic compounds
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Identifiers
PDB—
CAS-ID236395-14-5
RxCUI1482501
ChEMBL IDCHEMBL87992
ChEBI ID87016
PubChem CID179344
DrugBankDB09119
UNII IDS5VXA428R4 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 815 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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4,090 adverse events reported
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