idelalisib Oral Tablet

Brand(s)
Zydelig
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-09-08)
Oldest Current Product
2014-07-23
License(s)
NDA
RxNORM
ORAL TABLET\IDELALISIB
FDAOB
ORAL\TABLET\IDELALISIB
SPL Active
ORAL\TABLET, FILM COATED\IDELALISIB
SPL Moiety
ORAL\TABLET, FILM COATED\IDELALISIB

product(s) by strength(s)

idelalisib 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581701ZydeligNDAGilead Sciences, Inc.2014-07-23IDELALISIBORALTABLET, FILM COATEDNDA205858efbdafa9-d18c-4e85-b4a2-1e620fc74e50

idelalisib 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581702ZydeligNDAGilead Sciences, Inc.2014-07-23IDELALISIBORALTABLET, FILM COATEDNDA205858efbdafa9-d18c-4e85-b4a2-1e620fc74e50

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205858ZYDELIGGILEAD SCIENCES INC2014-07-23p9149477, INHIBITION ON PI3K KINASE
p8138195, FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA, SUBSTANCE
p8492389, SUBSTANCE
p6800620, A METHOD OF DISRUPTING LEUKOCYTE FUNCTION
p8865730, FOR THE TREATMENT OF PATIENTS WITH CLL, SUBSTANCE
pRE44638, SUBSTANCE
p8637533, SUBSTANCE
pRE44599, FOR THE TREATMENT OF PATIENTS WITH CLL/ FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA
p8980901, FOR THE TREATMENT OF PATIENTS WITH CLL
p6949535, A METHOD OF DISRUPTING LEUKOCYTE FUNCTION
NEW CHEMICAL ENTITY [2019-07-23]NDA205858_001, NDA205858_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205858_001RXIDELALISIB (100MG)ORALTABLETFalse2014-07-23ZYDELIG
2NDA205858_002RXIDELALISIB (150MG)ORALTABLETTrue2014-07-23ZYDELIG

patent(s)

#idexpiration dateapplication(s)
1p6800620 (view patent)2021-04-24NDA205858
2p6949535 (view patent)2021-04-24NDA205858
3p8138195 (view patent)2021-04-24NDA205858
4p8492389 (view patent)2021-04-24NDA205858
5p8637533 (view patent)2021-04-24NDA205858
6p8865730 (view patent)2033-03-05NDA205858
7p8980901 (view patent)2025-05-12NDA205858
8p9149477 (view patent)2025-05-12NDA205858
9pRE44599 (view patent)2025-07-21NDA205858
10pRE44638 (view patent)2025-08-05NDA205858

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1efbdafa9-d18c-4e85-b4a2-1e620fc74e50 (view SPL)These highlights do not include all the information needed to use ZYDELIG safely and effectively. See full prescribing information for ZYDELIG. ZYDELIG (idelalisib) tablets, for oral use Initial U.S. Approval: 2014prescriptionHuman PrescriptionGilead Sciences, Inc.2015-09-084619581701, 619581702

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