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Last Updated: August 11, 2022

VIEKIRA XR Drug Patent Profile


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DrugPatentWatch® 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 eighteen 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

DrugPatentWatch® Estimated 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 HospitalPhase 4
Patient-Centered Outcomes Research InstitutePhase 4
Merck Sharp & Dohme Corp.Phase 4

See all VIEKIRA XR clinical trials

US Patents and Regulatory Information for VIEKIRA XR

VIEKIRA XR is protected by twenty US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIEKIRA XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VIEKIRA XR

Solid antiviral dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

Compositions and methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

Anti-infective agents and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.

Solid pharmaceutical dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid pharmaceutical dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Macrocyclic hepatitis C serine protease inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.

Methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN

Anti-infective agents and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.

Macrocyclic hepatitis C serine protease inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR

Methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.

Methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN

Solid compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Anti-viral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Anti-viral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING OMBITASVIR

Compositions and methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR

Anti-infective agents and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR

Solid antiviral dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

Solid antiviral dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

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

Expired US Patents for VIEKIRA XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 See Plans and Pricing See Plans and Pricing
Abbvie Inc VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, EXTENDED RELEASE;ORAL 208624-001 Jul 22, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VIEKIRA XR

When does loss-of-exclusivity occur for VIEKIRA XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Patent: 89757
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1609195
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VIEKIRA XR around the world.

Country Patent Number Title Estimated Expiration
Japan 5911838 See Plans and Pricing
Slovenia 2368890 See Plans and Pricing
Germany 112012002748 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIEKIRA XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368890 PA2015012 Lithuania See Plans and Pricing PRODUCT NAME: OMBITASVIRUM; REGISTRATION NO/DATE: EU/1/14/982 20150115
2340029 132016000021931 Italy See Plans and Pricing PRODUCT NAME: PARITAPREVIR IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(VIEKIRAX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/982/001, 20150119
2692346 C201730039 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Baxter
Merck
Mallinckrodt
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 verification 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.