VIEKIRA XR Drug Patent Profile

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

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

This drug has six hundred and eight patent family members in fifty-four countries.

The generic ingredient in VIEKIRA XR is dasabuvir sodium; ombitasvir; paritaprevir; ritonavir. Additional details are available on the dasabuvir sodium; ombitasvir; paritaprevir; ritonavir profile page.

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 nine 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

Summary for VIEKIRA XR

International Patents:	608
US Patents:	20
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	22
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIEKIRA XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIEKIRA XR
DailyMed Link:	VIEKIRA XR at DailyMed

See drug prices for VIEKIRA XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIEKIRA XR

NDA:

208624

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
Patient-Centered Outcomes Research Institute	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

See all VIEKIRA XR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VIEKIRA XR

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for VIEKIRA XR

VIEKIRA XR is protected by twenty US patents.

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

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

Expired US Patents for VIEKIRA XR

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

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

Taiwan

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
Lithuania	2954892
Ukraine	118080	ПРОТИВІРУСНІ СПОЛУКИ
European Patent Office	2579854	COMPOSITIONS SOLIDES (SOLID COMPOSITIONS)
Austria	514003	Verfahren zur Behandlung von HCV umfassend mindestens zwei direkt wirkende antivirale Wirkstoffe, Ribavirin aber nicht Interferon
Japan	2013163680	MACROCYCLIC HEPATITIS C SERINE PROTEASE INHIBITOR

Supplementary Protection Certificates for VIEKIRA XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	122015000039	Germany		PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: EU/1/14/982 20150115
2692346	C201730039	Spain		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	C02340029/01	Switzerland		PRODUCT NAME: PARITAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 65301 25.11.2014
2203431	247 50008-2015	Slovakia		PRODUCT NAME: DASABUVIR (VO FORME MONOHYDRATU SODNEJ SOLI); REGISTRATION NO/DATE: EU/1/14/983/001 20150119
2203431	132016000021360	Italy		PRODUCT NAME: DASABUVIR IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(EXVIERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/983/001, 20150119