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Last Updated: January 26, 2020

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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 ninety 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.

US ANDA Litigation and Generic Entry Outlook for Viekira Xr

Viekira Xr was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 2, 2035. This may change due to patent challenges or generic licensing.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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

See drug prices for VIEKIRA XR

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
Massachusetts General HospitalN/A
AbbVieN/A
Patient-Centered Outcomes Research InstitutePhase 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   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   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 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 122017000074 Germany   Start Trial PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2340029 15C0021 France   Start Trial PRODUCT NAME: PARITAPREVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2368890 PA2015012,C2368890 Lithuania   Start Trial PRODUCT NAME: OMBITASVIRAS; REGISTRATION NO/DATE: EU/1/14/982 20150115
2203431 2015/009 Ireland   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
2692346 PA2017033 Lithuania   Start Trial PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; 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:

Dow
Johnson and Johnson
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Baxter
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Merck

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