Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

VIEKIRA XR Drug Profile

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Which patents cover Viekira Xr, and when can generic versions of Viekira Xr launch?

Viekira Xr is a drug marketed by Abbvie Inc and is included in one NDA. There are twenty-two patents protecting this drug.

This drug has five hundred and seventy patent family members in fifty-three countries.

The generic ingredient in VIEKIRA XR is dasabuvir sodium; ombitasvir; paritaprevir; ritonavir. One supplier is listed for this compound. Additional details are available on the dasabuvir sodium; ombitasvir; paritaprevir; ritonavir profile page.

Drug patent expirations by year for VIEKIRA XR
Drug Prices for VIEKIRA XR

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Generic Entry Opportunity Date for VIEKIRA XR
Generic Entry Date for VIEKIRA XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VIEKIRA XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AbbVieN/A
Massachusetts General HospitalN/A
University of FloridaPhase 4

See all VIEKIRA XR clinical trials

Recent Litigation for VIEKIRA XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
AbbVie Inc. v. Cipla Limited2017-11-10
AbbVie Inc. v. Aurobindo Pharma Limited2017-01-13
AbbVie Inc. v. Amneal Pharmaceuticals, LLC2016-05-27

See all VIEKIRA XR litigation

Synonyms for VIEKIRA XR
Dasabuvir / ombitasvir / paritaprevir / ritonavir
Dasabuvir combination with ombitasvir, paritaprevir and ritonavir
Ombitasvir, dasabuvir, paritaprevir, and ritonavir
S900006810
Viekira Pak
Viekira Pak (Copackaged)

US Patents and Regulatory Information for VIEKIRA XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VIEKIRA XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2692346 2017C/042 Belgium   Start Trial PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728
2340029 CR 2015 00013 Denmark   Start Trial PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEROF; REG. NO/DATE: EU/1/14/982 20150119
2692346 C201730039 Spain   Start Trial PRODUCT NAME: PIBRENTASVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1213; DATE OF AUTHORISATION: 20170726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1213; DATE OF FIRST AUTHORISATION IN EEA: 20170726
2340029 C20150019 00156 Estonia   Start Trial PRODUCT NAME: PARITAPREVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2203431 C20150015 00143 Estonia   Start Trial PRODUCT NAME: DASABUVIIR;REG NO/DATE: EU/1/14/983 19.01.2015
2692346 CR 2017 00049 Denmark   Start Trial PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2692346 122017000074 Germany   Start Trial PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Johnson and Johnson
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Dow

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