dimethyl fumarate Delayed Release Oral Capsule

Brand(s)
Tecfidera
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Biogen Idec Inc. (2015-04-09)
Oldest Current Product
2013-03-27
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL CAPSULE\DIMETHYL FUMARATE
FDAOB
ORAL\CAPSULE, DELAYED RELEASE\DIMETHYL FUMARATE
SPL Active
ORAL\CAPSULE\DIMETHYL FUMARATE
SPL Moiety
ORAL\CAPSULE\MONOMETHYL FUMARATE

product(s) by strength(s)

dimethyl fumarate 120 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1644060005TecfideraNDABiogen Idec Inc.2013-03-27DIMETHYL FUMARATEORALCAPSULENDA204063665d7e74-036c-5f68-5b67-ab84b9b49151

dimethyl fumarate 240 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1644060006TecfideraNDABiogen Idec Inc.2013-03-27DIMETHYL FUMARATEORALCAPSULENDA204063665d7e74-036c-5f68-5b67-ab84b9b49151

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204063TECFIDERABIOGEN IDEC INC2013-03-27p8759393, SUBSTANCE
p8524773, METHOD OF TREATING MULTIPLE SCLEROSIS
p7803840, METHOD OF TREATING AN AUTOIMMUNE DISEASE SELECTED FROM AUTOIMMUNE POLYARTHRITIS AND MULTIPLE SCLEROSIS BUT NOT TREATING PSORIATIC ARTHRITIS
p7619001, METHOD OF TREATING MULTIPLE SCLEROSIS
p8399514, METHOD OF TREATING MULTIPLE SCLEROSIS
p6509376, SUBSTANCE
p7320999, METHOD OF TREATING MULTIPLE SCLEROSIS
NEW CHEMICAL ENTITY [2018-03-27]NDA204063_001, NDA204063_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204063_001RXDIMETHYL FUMARATE (120MG)ORALCAPSULE, DELAYED RELEASEFalse2013-03-27TECFIDERA
2NDA204063_002RXDIMETHYL FUMARATE (240MG)ORALCAPSULE, DELAYED RELEASETrue2013-03-27TECFIDERA

patent(s)

#idexpiration dateapplication(s)
1p6509376 (view patent)2019-10-29NDA204063
2p7320999 (view patent)2020-05-18NDA204063
3p7619001 (view patent)2018-04-01NDA204063
4p7803840 (view patent)2018-04-01NDA204063
5p8399514 (view patent)2028-02-07NDA204063
6p8524773 (view patent)2018-04-01NDA204063
7p8759393 (view patent)2019-10-29NDA204063

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1665d7e74-036c-5f68-5b67-ab84b9b49151 (view SPL)These highlights do not include all the information needed to use TECFIDERA safely and effectively. See full prescribing information for TECFIDERA.TECFIDERA (dimethyl fumarate) delayed-release capsules, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionBiogen Idec Inc.2015-04-0932644060005, 644060006, 644060007

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII