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Drug ReportsTopiramate
Topiramate
Eprontia, Qsymia, Qudexy, Topamax, Topiramate, Trokendi (topiramate) is a small molecule pharmaceutical. Topiramate was first approved as Topamax on 1996-12-24. It is used to treat bipolar disorder, epilepsy, infantile spasms, lennox gastaut syndrome, and pain amongst others in the USA. It is known to target carbonic anhydrase 7, carbonic anhydrase 12, carbonic anhydrase 4, and carbonic anhydrase 1.
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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
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Eprontia, Qudexy, Topamax, Topiramate, Trokendi (discontinued: Topamax, Topiramate)
Combinations
Phentermine topiramate, Qsymia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Topiramate
Tradename
Company
Number
Date
Products
EPRONTIAAzurityN-214679 RX2021-11-05
1 products, RLD, RS
TOPAMAXJohnson & JohnsonN-020505 RX1996-12-24
4 products, RLD
TOPAMAXJohnson & JohnsonN-020844 RX1998-10-26
2 products, RLD, RS
TROKENDI XRSupernus PharmaceuticalsN-201635 RX2013-08-16
4 products, RLD, RS
QUDEXY XRUpsher-Smith LaboratoriesN-205122 RX2014-03-11
5 products, RLD, RS
Show 2 discontinued
Phentermine hydrochloride
+
Topiramate
Tradename
Company
Number
Date
Products
QSYMIAVivusN-022580 RX2012-07-17
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
eprontiaNew Drug Application2025-03-21
phentermine and topiramateANDA2025-06-24
phentermine and topiramate extended-releaseANDA2025-05-21
qsymiaNew Drug Application2024-10-03
qudexyNew Drug Application2025-02-07
qudexy qudexyNew Drug Application2025-03-03
qudexy qudexyNew Drug Application2025-04-10
topamaxNew Drug Application2025-03-24
topiramateANDA2025-07-24
topiramate tablets2009-04-03
Show 2 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
epilepsyEFO_0000474D004827G40.9
lennox gastaut syndrome—D065768G40.81
infantile spasmsEFO_1000643D013036G40.82
partial epilepsiesEFO_0004263D004828—
tonic-clonic epilepsyEFO_0007262D004830—
bipolar disorderEFO_0000289D001714F30.9
obesityEFO_0001073D009765E66.9
Agency Specific
FDA
EMA
Expiration
Code
PHENTERMINE HYDROCHLORIDE / TOPIRAMATE, QSYMIA, VIVUS
2025-06-24NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Topiramate, Eprontia, Azurity
114330462040-08-21U-3413, U-3414, U-3415
116333742040-08-21DP
Topiramate, Qudexy Xr, Upsher Smith Labs
86525272033-03-19DP
88891902033-03-19DP
91015452033-03-19DP
95550052033-03-19DP
103632242033-03-19U-766
Phentermine Hydrochloride / Topiramate, Qsymia, Vivus
85802992029-06-14U-3399
85802982029-05-15DP
88950572028-06-09U-3398
88950582028-06-09DP
90119052028-06-09DP
90119062028-06-09U-3398
Topiramate, Trokendi Xr, Supernus Pharms
82985762028-04-04DPU-106, U-1992
82985802027-11-16DPU-106, U-1992
86636832027-11-16DPU-106, U-1992
88772482027-11-16DPU-106, U-1992
88891912027-11-16U-106, U-1992
89929892027-11-16DPU-1675, U-1992
95499402027-11-16DPU-1675, U-1992
95550042027-11-16DPU-1675, U-1992
96229832027-11-16DPU-1675, U-1992
103147902027-11-16DPU-1675, U-1992
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX11: Topiramate
HCPCS
No data
Clinical
Clinical Trials
338 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G43———2—2
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTopiramate
INNtopiramate
Description
Topiramate is a hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. It has a role as an anticonvulsant and a sodium channel blocker. It is a cyclic ketal, a sulfamate ester and a ketohexose derivative.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1(C)O[C@@H]2CO[C@@]3(COS(N)(=O)=O)OC(C)(C)O[C@H]3[C@@H]2O1
Identifiers
PDB—
CAS-ID97240-79-4
RxCUI—
ChEMBL IDCHEMBL220492
ChEBI ID63631
PubChem CID5284627
DrugBankDB00273
UNII ID0H73WJJ391 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CA7
CA7
CA12
CA12
CA4
CA4
CA1
CA1
Organism
Homo sapiens
Gene name
CA7
Gene synonyms
NCBI Gene ID
766
Protein name
carbonic anhydrase 7
Protein synonyms
CA-VII, Carbonate dehydratase VII, Carbonic anhydrase VII, carbonic dehydratase VII
Uniprot ID
P43166
Mouse ortholog
Car7 (12354)
carbonic anhydrase 7 (Q9ERQ8)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Trokendi – Supernus Pharmaceuticals
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Qsymia – Vivus
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Estimated US medical usage
Topiramate
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 64,177 documents
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Safety
Black-box Warning
Black-box warning for: Qudexy, Qudexy qudexy
Adverse Events
Top Adverse Reactions
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46,593 adverse events reported
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