tasimelteon Oral Capsule

Brand(s)
Hetlioz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Vanda Pharmaceuticals Inc. (2014-12-18)
Oldest Current Product
2014-04-04
License(s)
NDA
RxNORM
ORAL CAPSULE\TASIMELTEON
FDAOB
ORAL\CAPSULE\TASIMELTEON
SPL Active
ORAL\CAPSULE\TASIMELTEON
SPL Moiety
ORAL\CAPSULE\TASIMELTEON

product(s) by strength(s)

tasimelteon 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1430680220HetliozNDAVanda Pharmaceuticals Inc.2014-04-04TASIMELTEONORALCAPSULENDA205677ca4a9b63-708e-49e9-8f9b-010625443b90

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205677HETLIOZVANDA PHARMACEUTICALS INC2014-01-31p5856529, TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER, SUBSTANCE
p9060995, TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH FLUVOXAMINE
p8785492, TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
NEW CHEMICAL ENTITY [2019-01-31]
ORPHAN DRUG EXCLUSIVITY [2021-01-31]
NDA205677_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205677_001RXTASIMELTEON (20MG)ORALCAPSULETrue2014-01-31HETLIOZ

patent(s)

#idexpiration dateapplication(s)
1p5856529 (view patent)2017-12-09NDA205677
2p8785492 (view patent)2033-01-25NDA205677
3p9060995 (view patent)2033-01-25NDA205677

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ca4a9b63-708e-49e9-8f9b-010625443b90 (view SPL)These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ (tasimelteon) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionVanda Pharmaceuticals Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-12-185430680220

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