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Last Updated: May 26, 2020

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VIEKIRA XR Drug Profile


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When do Viekira Xr patents expire, and what generic alternatives are available?

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

This drug has five hundred and ninety-three 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.

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

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Recent Clinical Trials for VIEKIRA XR

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SponsorPhase
Massachusetts General HospitalN/A
AbbVieN/A
Patient-Centered Outcomes Research InstitutePhase 4

See all VIEKIRA XR clinical trials

Recent Litigation for VIEKIRA XR

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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 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
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
2203431 CR 2015 00014 Denmark   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2203431 C02203431/01 Switzerland   Start Trial BEI DER ANMELDUNG WURDE DER INHABER IRRTUEMLICH DOPPELT ERFASST.
2368890 CR 2015 00015 Denmark   Start Trial PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150119
2340029 C 2015 019 Romania   Start Trial PRODUCT NAME: PARITAPREVIR; NATIONAL AUTHORISATION NUMBER: EU/1/14/982; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/982; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2203431 PA2015013,C2203431 Lithuania   Start Trial PRODUCT NAME: DASABUVIRAS; REGISTRATION NO/DATE: EU/1/14/983 20150115
2340029 32/2015 Austria   Start Trial PRODUCT NAME: PARITAPREVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER ANNEHMBARER ESTER DAVON; REGISTRATION NO/DATE: (MITTEILUNG VOM 19.1.2015) EU/1/14/982 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Medtronic
Mallinckrodt
Moodys
Merck

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