darunavir Oral Suspension

Brand(s)
Prezista
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Products, Lp (2015-06-08)
Oldest Current Product
2011-12-16
License(s)
NDA
RxNORM
ORAL SUSPENSION\DARUNAVIR
FDAOB
ORAL\SUSPENSION\DARUNAVIR ETHANOLATE
SPL Active
ORAL\SUSPENSION\DARUNAVIR ETHANOLATE
SPL Moiety
ORAL\SUSPENSION\DARUNAVIR

product(s) by strength(s)

darunavir 100 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760565PrezistaNDAJanssen Products, Lp2011-12-16DARUNAVIR ETHANOLATEORALSUSPENSIONNDA202895814301f9-c990-46a5-b481-2879a521a16f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202895PREZISTAJANSSEN PRODUCTS LP2011-12-16pRE43596, SUBSTANCE
p5843946, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS/ TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, SUBSTANCE
p6703403, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS/ TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS
p8597876, TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS
p7470506, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS/ TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS
pRE42889, SUBSTANCE
p8518987, SUBSTANCE
p6037157, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS/ TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS
p7700645, SUBSTANCE
pRE43802, TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS
p6248775
NEW DOSAGE FORM [2014-12-16]
PEDIATRIC EXCLUSIVITY [2015-06-16]
PEDIATRIC EXCLUSIVITY [2016-08-01]
UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED [2016-02-01]
NDA202895_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202895_001RXDARUNAVIR ETHANOLATE (EQ 100MG BASE/ML)ORALSUSPENSIONTrue2011-12-16PREZISTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5843946 (view patent)2015-12-01NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet
2p6037157 (view patent)2016-06-26NDA202895, NDA020659, NDA020945, NDA021226, NDA021251, NDA021906, NDA021976, NDA022417, NDA206619, NDA207931lopinavir / Ritonavir Oral Solution
ombitasvir / paritaprevir / Ritonavir Oral Tablet
darunavir Oral Tablet
lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
Ritonavir Oral Capsule
Ritonavir Oral Solution
3p6248775 (view patent)2014-08-13NDA202895, NDA021976darunavir Oral Tablet
4p6703403 (view patent)2016-06-26NDA202895, NDA020659, NDA020945, NDA021226, NDA021251, NDA021906, NDA021976, NDA022417, NDA206619, NDA207931lopinavir / Ritonavir Oral Solution
ombitasvir / paritaprevir / Ritonavir Oral Tablet
darunavir Oral Tablet
lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
Ritonavir Oral Capsule
Ritonavir Oral Solution
5p7470506 (view patent)2019-06-23NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet
6p7700645 (view patent)2026-12-26NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet
7p8518987 (view patent)2024-02-16NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet
8p8597876 (view patent)2019-06-23NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet
9pRE42889 (view patent)2016-10-19NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet
10pRE43596 (view patent)2017-05-09NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet
11pRE43802 (view patent)2016-10-19NDA202895, NDA021976, NDA205395cobicistat / darunavir Oral Tablet
darunavir Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1814301f9-c990-46a5-b481-2879a521a16f (view SPL)These highlights do not include all the information needed to use PREZISTA safely and effectively. See Full Prescribing Information for PREZISTA. PREZISTA (darunavir) oral suspensionPREZISTA (darunavir) tablet, for oral use Initial U.S. Approval 2006prescriptionHuman PrescriptionJanssen Products, LpANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-0831596760565, 596760561, 596760562, 596760563, 596760564, 596760566darunavir Oral Tablet

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