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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Serving leading biopharmaceutical companies globally:

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Last Updated: December 12, 2019

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VIEKIRA XR Drug Profile

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When do Viekira Xr patents expire, 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 eighty-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 19th, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 2nd, 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.

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 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
>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
2368890 CA 2015 00015 Denmark   Start Trial PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150115
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
2692346 1790050-7 Sweden   Start Trial PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2692346 299 50017-2017 Slovakia   Start Trial PRODUCT NAME: PIBRENTASVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1213 20170728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
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Mallinckrodt
Baxter
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.