ombitasvir / paritaprevir / Ritonavir Oral Tablet

Brand(s)
Technivie
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Abbvie Inc. (2015-10-22)
Oldest Current Product
2015-07-24
License(s)
NDA
RxNORM
ORAL TABLET\OMBITASVIR:PARITAPREVIR:RITONAVIR
FDAOB
ORAL\TABLET\OMBITASVIR: PARITAPREVIR: RITONAVIR
SPL Active
ORAL\TABLET, FILM COATED\OMBITASVIR HEMINONAHYDRATE: PARITAPREVIR DIHYDRATE: RITONAVIR
SPL Moiety
ORAL\TABLET, FILM COATED\OMBITASVIR: PARITAPREVIR: RITONAVIR

product(s) by strength(s)

ombitasvir 12.5 mg / paritaprevir 75 mg / ritonavir 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743082TechnivieNDAAbbvie Inc.2015-07-24OMBITASVIR HEMINONAHYDRATE, PARITAPREVIR DIHYDRATE, RITONAVIRORALTABLET, FILM COATEDNDA20793185130606-e6a4-cf08-4bac-a460a30b0984

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207931TECHNIVIEABBVIE INC2015-07-24p7148359, SUBSTANCE
p8268349, SUBSTANCE
p8420596, SUBSTANCE
p7364752, SUBSTANCE
p9044480, TREATMENT OF HCV INFECTION USING PARITAPREVIR
p8642538, TREATMENT OF HCV INFECTION USING PARITAPREVIR, SUBSTANCE
p8399015, SUBSTANCE
p6037157, USE OF RITONAVIR AS A POTENT CYP3A INHIBITOR TO INCREASE PLASMA DRUG CONCENTRATION OF PARITAPREVIR AND OVERALL DRUG EXPOSURE FOR TREATMENT OF HCV INFECTION
p8691938, SUBSTANCE
p9006387, TREATMENT OF HCV INFECTION USING OMBITASVIR
p6703403, USE OF RITONAVIR AS A POTENT CYP3A INHIBITOR TO INCREASE PLASMA DRUG CONCENTRATION OF PARITAPREVIR AND OVERALL DRUG EXPOSURE FOR TREATMENT OF HCV INFECTION
p8686026, SUBSTANCE
NEW CHEMICAL ENTITY [2019-12-19]
NEW PRODUCT [2018-07-24]
NDA207931_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207931_001RXOMBITASVIR (12.5MG), RITONAVIR (50MG), PARITAPREVIR (75MG)ORALTABLETTrue2015-07-24TECHNIVIE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6037157 (view patent)2016-06-26NDA207931, NDA020659, NDA020945, NDA021226, NDA021251, NDA021906, NDA021976, NDA022417, NDA202895, NDA206619lopinavir / Ritonavir Oral Solution
darunavir Oral Suspension
darunavir Oral Tablet
lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
Ritonavir Oral Capsule
Ritonavir Oral Solution
2p6703403 (view patent)2016-06-26NDA207931, NDA020659, NDA020945, NDA021226, NDA021251, NDA021906, NDA021976, NDA022417, NDA202895, NDA206619lopinavir / Ritonavir Oral Solution
darunavir Oral Suspension
darunavir Oral Tablet
lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
Ritonavir Oral Capsule
Ritonavir Oral Solution
3p7148359 (view patent)2019-07-19NDA207931, NDA021906, NDA022417, NDA206619lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
4p7364752 (view patent)2020-11-10NDA207931, NDA021906, NDA022417, NDA206619lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
5p8268349 (view patent)2024-08-25NDA207931, NDA021906, NDA022417, NDA206619lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
6p8399015 (view patent)2024-08-25NDA207931, NDA021906, NDA022417, NDA206619lopinavir / Ritonavir Oral Tablet
Ritonavir Oral Tablet
7p8420596 (view patent)2031-04-10NDA207931, NDA206619
8p8642538 (view patent)2029-09-10NDA207931, NDA206619
9p8686026 (view patent)2031-06-09NDA207931, NDA206619
10p8691938 (view patent)2032-04-13NDA207931, NDA206619
11p9006387 (view patent)2030-06-10NDA207931, NDA206619
12p9044480 (view patent)2031-04-10NDA207931, NDA206619

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
185130606-e6a4-cf08-4bac-a460a30b0984 (view SPL)These highlights do not include all the information needed to use TECHNIVIE safely and effectively. See full prescribing information for TECHNIVIE. TECHNIVIE (ombitasvir, paritaprevir and ritonavir) tablets, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionAbbvie Inc.2015-10-2253000743082

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