Ibrutinib Oral Capsule

Brand(s)
Imbruvica
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacyclics, Inc (2015-02-13)
Oldest Current Product
2013-11-07
License(s)
NDA
RxNORM
ORAL CAPSULE\IBRUTINIB
FDAOB
ORAL\CAPSULE\IBRUTINIB
SPL Active
ORAL\CAPSULE\IBRUTINIB
SPL Moiety
ORAL\CAPSULE\IBRUTINIB

product(s) by strength(s)

ibrutinib 140 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1579620140ImbruvicaNDAPharmacyclics, Inc2013-11-07IBRUTINIBORALCAPSULENDA2055520dfd0279-ff17-4ea9-89be-9803c71bab44

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205552IMBRUVICAPHARMACYCLICS INC2013-11-13p8497277, TREATMENT OF MANTLE CELL LYMPHOMA/ TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA/ TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
p8476284, TREATMENT OF MANTLE CELL LYMPHOMA/ TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
p8999999, TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/ TREATMENT FRO CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
p8957079, SUBSTANCE
p8697711, SUBSTANCE
p9125889, FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
p8754091, SUBSTANCE
p8754090, TREATMENT OF MANTLE CELL LYMPHOMA
p8008309, SUBSTANCE
p8703780, TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
p7514444, SUBSTANCE
p8735403, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2022-01-29]
ORPHAN DRUG EXCLUSIVITY [2021-07-28]
ORPHAN DRUG EXCLUSIVITY [2021-02-12]
ORPHAN DRUG EXCLUSIVITY [2020-11-13]
TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION [2017-07-28]
FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM MACROGLOBULINEMIA [2018-01-29]
TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY [2017-02-12]
NEW CHEMICAL ENTITY [2018-11-13]
NDA205552_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205552_001RXIBRUTINIB (140MG)ORALCAPSULETrue2013-11-13IMBRUVICA

patent(s)

#idexpiration dateapplication(s)
1p7514444 (view patent)2026-12-28NDA205552
2p8008309 (view patent)2026-12-28NDA205552
3p8476284 (view patent)2026-12-28NDA205552
4p8497277 (view patent)2026-12-28NDA205552
5p8697711 (view patent)2026-12-28NDA205552
6p8703780 (view patent)2026-12-28NDA205552
7p8735403 (view patent)2026-12-28NDA205552
8p8754090 (view patent)2031-06-03NDA205552
9p8754091 (view patent)2026-12-28NDA205552
10p8957079 (view patent)2026-12-28NDA205552
11p8999999 (view patent)2031-06-03NDA205552
12p9125889 (view patent)2031-06-03NDA205552

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10dfd0279-ff17-4ea9-89be-9803c71bab44 (view SPL)These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA (ibrutinib) capsules, for oral use Initial U.S. Approval: 2013prescriptionHuman PrescriptionPharmacyclics, IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK, PARTICLE SIZE REDUCTION2015-02-136579620140

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