Sumatriptan Transdermal Patch

Brand(s)
Zecuity
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Nupathe Inc. (2015-08-25)
Oldest Current Product
2015-08-25
License(s)
NDA
RxNORM
TRANSDERMAL PATCH\SUMATRIPTAN
FDAOB
IONTOPHORESIS\SYSTEM\SUMATRIPTAN SUCCINATE\rdfq
SPL Active
TRANSDERMAL\PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED\SUMATRIPTAN SUCCINATE
SPL Moiety
TRANSDERMAL\PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED\SUMATRIPTAN

product(s) by strength(s)

sumatriptan 1.63 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1517590101ZecuityNDANupathe Inc.2015-08-25SUMATRIPTAN SUCCINATETRANSDERMALPATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLEDNDA202278806a07a0-e042-11df-9548-0002a5d5c51b

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202278ZECUITYTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC2013-01-17p6745071, SUBSTANCE
p8983594, METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, SUBSTANCE
p8366600, METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS
p8470853, METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS
p7973058, METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS
p8155737, METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS
p8597272, SUBSTANCE
NEW DOSAGE FORM [2016-01-17]NDA202278_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routerldapprovedapplication
1NDA202278_001RXSUMATRIPTAN SUCCINATE (EQ 6.5MG BASE/4HR)IONTOPHORESISTrue2013-01-17ZECUITY

patent(s)

#idexpiration dateapplication(s)
1p6745071 (view patent)2023-02-21NDA202278
2p7973058 (view patent)2027-04-12NDA202278
3p8155737 (view patent)2027-04-12NDA202278
4p8366600 (view patent)2029-04-21NDA202278
5p8470853 (view patent)2027-04-12NDA202278
6p8597272 (view patent)2027-04-12NDA202278
7p8983594 (view patent)2030-11-19NDA202278

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1806a07a0-e042-11df-9548-0002a5d5c51b (view SPL)These highlights do not include all the information needed to use ZECUITY safely and effectively. See full prescribing information for ZECUITY.ZECUITY (sumatriptan iontophoretic transdermal system) Initial U.S. Approval: 1992prescriptionHuman PrescriptionNupathe Inc.2015-08-258517590101

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