rolapitant Oral Tablet

Brand(s)
Varubi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Tesaro, Inc. (2015-10-07)
Oldest Current Product
2015-10-07
License(s)
NDA
RxNORM
ORAL TABLET\ROLAPITANT
FDAOB
ORAL\TABLET\ROLAPITANT HYDROCHLORIDE
SPL Active
ORAL\TABLET\ROLAPITANT HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\ROLAPITANT

product(s) by strength(s)

rolapitant 90 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1696560101VarubiNDATesaro, Inc.2015-10-07ROLAPITANT HYDROCHLORIDEORALTABLETNDA206500ed3ef3f8-8cb7-40db-9d75-e728ee607760

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206500VARUBITESARO INC2015-09-01p8178550, SUBSTANCE
p7981905, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY/ ROLAPITANT IS APPROVED FOR THE PREVENTION OF DELAYED NAUSEA AND VOMITING (I.E.
p8470842, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
p7049230, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY, SUBSTANCE
p8404702, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
p8796299, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
p7563801, SUBSTANCE
p8361500, SUBSTANCE
NEW CHEMICAL ENTITY [2020-09-01]NDA206500_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206500_001RXROLAPITANT HYDROCHLORIDE (EQ 90MG BASE)ORALTABLETTrue2015-09-01VARUBI

patent(s)

#idexpiration dateapplication(s)
1p7049230 (view patent)2023-12-08NDA206500
2p7563801 (view patent)2027-04-04NDA206500
3p7981905 (view patent)2027-04-04NDA206500
4p8178550 (view patent)2027-04-04NDA206500
5p8361500 (view patent)2029-10-09NDA206500
6p8404702 (view patent)2029-10-09NDA206500
7p8470842 (view patent)2029-01-18NDA206500
8p8796299 (view patent)2022-12-17NDA206500

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ed3ef3f8-8cb7-40db-9d75-e728ee607760 (view SPL)These highlights do not include all the information needed to use VARUBI safely and effectively. See full prescribing information for VARUBI. VARUBI (rolapitant) tablets, for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionTesaro, Inc.2015-10-073696560101

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