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Drug ReportsDimethyl fumarate
Tecfidera(dimethyl fumarate)
Dimethyl, Skilarence, Tecfidera (dimethyl fumarate) is a small molecule pharmaceutical. Dimethyl fumarate was first approved as Tecfidera on 2013-03-27. It has been approved in Europe to treat multiple sclerosis, psoriasis, and relapsing-remitting multiple sclerosis.
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Clinical
Drug
Target
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
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
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Tecfidera (generic drugs available since 2020-08-17)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dimethyl fumarate
Tradename
Company
Number
Date
Products
TECFIDERABiogenN-204063 RX2013-03-27
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dimethyl fumarateANDA2024-01-21
dimethyl fumarate dimethyl fumarateANDA2023-04-06
tecfideraNew Drug Application2023-12-01
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
DIMETHYL FUMARATE, TECFIDERA, BIOGEN INC
2023-02-05M-260
Patent Expiration
Patent
Expires
Flag
FDA Information
Dimethyl Fumarate, Tecfidera, Biogen Inc
109599722035-11-16U-1384
110071662035-11-16U-1384
110071672035-11-16U-1384
111298062035-11-16U-1384
112468502035-11-16U-1384
103911602035-03-13U-3148
105559932035-03-13U-3148
109940032035-03-13U-3148
83995142028-02-07U-1384
ATC Codes
L: Antineoplastic and immunomodulating agents
L04: Immunosuppressants
L04A: Immunosuppressants
L04AX: Other immunosuppressants in atc
L04AX07: Dimethyl fumarate
HCPCS
No data
Clinical
Clinical Trials
158 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35247112953
Relapsing-remitting multiple sclerosisD020529EFO_00039293412121242
PsoriasisD011565EFO_0000676L401163112
Chronic progressive multiple sclerosisD020528EFO_000384011114
Type 2 diabetes mellitusD003924EFO_0001360E11134
HyperglycemiaD006943HP_0003074R73.9224
Cardiovascular diseasesD002318HP_000162611
KetosisD007662HP_0002919R82.411
Diabetic ketoacidosisD016883EFO_100089711
StrokeD020521EFO_0000712I63.911
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Indications Phases 3
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary hypertensionD006976EFO_0001361I27.2011
Systemic sclerodermaD012595EFO_0000717M3411
GlioblastomaD005909EFO_000051511
GliosarcomaD01831611
Indications Without Phase
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDimethyl fumarate
INN
Description
Dimethyl fumarate is an enoate ester resulting from the formal condensation of both carboxy groups of fumaric acid with methanol. Used for treatment of adults with relapsing forms of multiple sclerosis. It has a role as an immunomodulator and an antipsoriatic. It is an enoate ester, a methyl ester and a diester. It is functionally related to a methanol and a fumaric acid.
Classification
Small molecule
Drug class
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COC(=O)/C=C/C(=O)OC
Identifiers
PDB
CAS-ID624-49-7
RxCUI
ChEMBL IDCHEMBL2107333
ChEBI ID76004
PubChem CID637568
DrugBankDB08908
UNII ID
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Tecfidera Biogen
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Estimated US medical usage
Dimethyl fumarate
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,284 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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104,522 adverse events reported
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