eluxadoline Oral Tablet

Brand(s)
Viberzi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2015-05-27)
Oldest Current Product
2015-11-01
License(s)
NDA
RxNORM
ORAL TABLET\ELUXADOLINE
FDAOB
ORAL\TABLET\ELUXADOLINE
SPL Active
ORAL\TABLET, FILM COATED\ELUXADOLINE
SPL Moiety
ORAL\TABLET, FILM COATED\ELUXADOLINE

product(s) by strength(s)

eluxadoline 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1618740100ViberziNDAActavis Pharma, Inc.2015-11-01ELUXADOLINEORALTABLET, FILM COATEDNDA2069407821bd40-4c84-4984-951b-6436ae20421a

eluxadoline 75 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1618740075ViberziNDAActavis Pharma, Inc.2015-11-01ELUXADOLINEORALTABLET, FILM COATEDNDA2069407821bd40-4c84-4984-951b-6436ae20421a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206940VIBERZIFOREST TOSARA LTD2015-05-27p8691860, TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
p7741356, SUBSTANCE
p7786158
p8609709
p9115091, TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE), SUBSTANCE
p8344011, TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
NEW CHEMICAL ENTITY [2020-05-27]NDA206940_001, NDA206940_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206940_001RXELUXADOLINE (75MG)ORALTABLETFalse2015-05-27VIBERZI
2NDA206940_002RXELUXADOLINE (100MG)ORALTABLETTrue2015-05-27VIBERZI

patent(s)

#idexpiration dateapplication(s)
1p7741356 (view patent)2028-03-25NDA206940
2p7786158 (view patent)2025-03-14NDA206940
3p8344011 (view patent)2025-03-14NDA206940
4p8609709 (view patent)2025-03-14NDA206940
5p8691860 (view patent)2028-07-07NDA206940
6p9115091 (view patent)2028-07-07NDA206940

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17821bd40-4c84-4984-951b-6436ae20421a (view SPL)These highlights do not include all the information needed to use VIBERZI safely and effectively. See full prescribing information for VIBERZI.VIBERZI (eluxadoline) tablets, for oral use, C-X Initial U.S. Approval: 2015prescriptionHuman PrescriptionActavis Pharma, Inc.LABEL, MANUFACTURE, PACK2015-05-271618740075, 618740100

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