ingenol mebutate Topical Gel

Brand(s)
Picato
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Leo Pharma Inc. (2015-10-14)
Oldest Current Product
2012-01-23
License(s)
NDA
RxNORM
TOPICAL GEL\INGENOL MEBUTATE
FDAOB
TOPICAL\GEL\INGENOL MEBUTATE
SPL Active
TOPICAL\GEL\INGENOL MEBUTATE
SPL Moiety
TOPICAL\GEL\INGENOL MEBUTATE

product(s) by strength(s)

ingenol mebutate 0.00015 mg/mg topical gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502220502PicatoNDALeo Pharma Inc.2012-01-23INGENOL MEBUTATETOPICALGELNDA2028335accc7a5-8209-4680-b0ae-2a6963500419

ingenol mebutate 0.0005 mg/mg topical gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502220503PicatoNDALeo Pharma Inc.2012-01-23INGENOL MEBUTATETOPICALGELNDA2028335accc7a5-8209-4680-b0ae-2a6963500419

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202833PICATOLEO PHARMA AS2012-01-23p8377919, SUBSTANCE
p6432452, TREATMENT OF ACTINIC KERATOSIS
p8372828, SUBSTANCE
p8372827, SUBSTANCE
p8536163, USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
p8735375, USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
p6844013, TO STIMULATE THE IMMUNE SYSTEM TO INDUCE T CELL PROLIFERATION, SUBSTANCE
p7410656, TO INHIBIT THE PROLIFERATIVE ACTIVITY OF NEOPLASTIC CELLS
p8278292, SUBSTANCE
p8716271, USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
NEW CHEMICAL ENTITY [2017-01-23]NDA202833_001, NDA202833_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202833_001RXINGENOL MEBUTATE (0.015%)TOPICALGELTrue2012-01-23PICATO
2NDA202833_002RXINGENOL MEBUTATE (0.05%)TOPICALGELTrue2012-01-23PICATO

patent(s)

#idexpiration dateapplication(s)
1p6432452 (view patent)2018-08-19NDA202833
2p6844013 (view patent)2018-12-13NDA202833
3p7410656 (view patent)2018-08-19NDA202833
4p8278292 (view patent)2027-02-20NDA202833
5p8372827 (view patent)2026-12-18NDA202833
6p8372828 (view patent)2026-12-18NDA202833
7p8377919 (view patent)2026-12-18NDA202833
8p8536163 (view patent)2026-12-18NDA202833
9p8716271 (view patent)2026-12-18NDA202833
10p8735375 (view patent)2026-12-18NDA202833

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15accc7a5-8209-4680-b0ae-2a6963500419 (view SPL)These highlights do not include all the information needed to usePICATO gel safely and effectively. See full prescribing information for PICATO gel. PICATO (ingenol mebutate) gel, 0.015% for topical use PICATO (ingenol mebutate) gel, 0.05% for topical use Initial U.S. Approval: 2012prescriptionHuman PrescriptionLeo Pharma Inc.analysis, api manufacture, manufacture2015-10-144502220502, 502220503

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