fingolimod Oral Capsule

Brand(s)
Gilenya
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-08-05)
Oldest Current Product
2010-09-21
License(s)
NDA
RxNORM
ORAL CAPSULE\FINGOLIMOD
FDAOB
ORAL\CAPSULE\FINGOLIMOD
SPL Active
ORAL\CAPSULE\FINGOLIMOD HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\FINGOLIMOD

product(s) by strength(s)

fingolimod 0.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780607GilenyaNDANovartis Pharmaceuticals Corporation2010-09-21FINGOLIMOD HYDROCHLORIDEORALCAPSULENDA022527cc9e1c8c-0e2b-44e2-878b-27057f786be9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022527GILENYANOVARTIS PHARMACEUTICALS CORP2010-09-21p6004565, TREATMENT OF AUTOIMMUNE DISEASE
p5604229, TREATMENT OF AUTOIMMUNE DISEASE
p8324283
ADDITION OF THE T1-WEIGHTED GD-ENHANCED LESION EFFICACY VARIABLE IN THE CLINICAL STUDIES SECTION 14 OF THE PACKAGE INSERT [2014-07-20]
NEW CHEMICAL ENTITY [2015-09-21]
NDA022527_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022527_001RXFINGOLIMOD (0.5MG)ORALCAPSULETrue2010-09-21GILENYA

patent(s)

#idexpiration dateapplication(s)
1p5604229 (view patent)2019-02-18NDA022527
2p6004565 (view patent)2017-09-23NDA022527
3p8324283 (view patent)2026-03-29NDA022527

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1cc9e1c8c-0e2b-44e2-878b-27057f786be9 (view SPL)These highlights do not include all the information needed to use GILENYA safely and effectively. See full prescribing information for GILENYA. GILENYA (fingolimod) capsules, for oral use Initial U.S. Approval: 2010prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-08-0518000780607

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