Rilpivirine Oral Tablet

Brand(s)
Edurant
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Products, Lp (2015-08-31)
Oldest Current Product
2011-05-20
License(s)
NDA
RxNORM
ORAL TABLET\RILPIVIRINE
FDAOB
ORAL\TABLET\RILPIVIRINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\RILPIVIRINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\RILPIVIRINE

product(s) by strength(s)

rilpivirine 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760278EdurantNDAJanssen Products, Lp2011-05-20RILPIVIRINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA20202203880372-2c68-45c6-a53a-f420c49541d6

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202022EDURANTJANSSEN PRODUCTS LP2011-05-20p7067522, SUBSTANCE
p7638522, SUBSTANCE
p6838464, SUBSTANCE
p8080551, SUBSTANCE
p7125879, IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS/ IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE ADULT PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100/ IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100, SUBSTANCE
p8101629, SUBSTANCE
NEW CHEMICAL ENTITY [2016-05-20]
NEW PATIENT POPULATION [2018-08-26]
NDA202022_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202022_001RXRILPIVIRINE HYDROCHLORIDE (EQ 25MG BASE)ORALTABLETTrue2011-05-20EDURANT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6838464 (view patent)2021-02-26NDA202022, NDA202123emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
2p7067522 (view patent)2019-12-20NDA202022, NDA202123emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
3p7125879 (view patent)2022-08-09NDA202022, NDA202123emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
4p7638522 (view patent)2023-04-14NDA202022
5p8080551 (view patent)2023-04-11NDA202022, NDA202123emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
6p8101629 (view patent)2022-08-09NDA202022, NDA202123emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103880372-2c68-45c6-a53a-f420c49541d6 (view SPL)These highlights do not include all the information needed to use EDURANT safely and effectively. See full prescribing information for EDURANT. EDURANT (rilpivirine) tablets for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionJanssen Products, LpANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-3111596760278

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