VIEKIRA PAK (COPACKAGED) Drug Patent Profile

When do Viekira Pak (copackaged) patents expire, and when can generic versions of Viekira Pak (copackaged) launch?

Viekira Pak (copackaged) is a drug marketed by Abbvie Inc and is included in one NDA. There are seventeen patents protecting this drug.

This drug has six hundred and sixteen patent family members in fifty-three countries.

The generic ingredient in VIEKIRA PAK (COPACKAGED) 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.

DrugPatentWatch^® Generic Entry Outlook for Viekira Pak (copackaged)

Viekira Pak (copackaged) 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 October 18, 2033. This may change due to patent challenges or generic licensing.

There have been twenty 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 PAK (COPACKAGED)

International Patents:	616
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	42
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIEKIRA PAK (COPACKAGED)
DailyMed Link:	VIEKIRA PAK (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VIEKIRA PAK (COPACKAGED)

NDA:

206619

Dosage:

TABLET, TABLET;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.

Anatomical Therapeutic Chemical (ATC) Classes for VIEKIRA PAK (COPACKAGED)

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 PAK (COPACKAGED)

VIEKIRA PAK (COPACKAGED) is protected by seventeen 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 PAK (COPACKAGED)

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 PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No			Y	Y
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No			Y	Y
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No			Y
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No

Expired US Patents for VIEKIRA PAK (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014
Abbvie Inc	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014

International Patents for VIEKIRA PAK (COPACKAGED)

When does loss-of-exclusivity occur for VIEKIRA PAK (COPACKAGED)?

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

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

Singapore

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 PAK (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201408665
Poland	2206500
Australia	2010258769	Anti-viral compounds to treat HCV infection
South Korea	20140143152	ANTI-VIRAL COMPOUNDS
Israel	122546	COMBINATION OF RITONAVIR AND A DRUG METABOLIZED BY CYTOCHROME P450 MONOXYGENASE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340029	304 50009-2015	Slovakia		PRODUCT NAME: PARITAPREVIR; REGISTRATION NO/DATE: EU/1/14/982/001 20150119
2203431	C02203431/01	Switzerland		FORMER OWNER: ABBVIE BAHAMAS LIMITED, BS
2203431	38/2015	Austria		PRODUCT NAME: DASABUVIR ODER EIN SALZ DAVON, EINSCHLIESSLICH DASABUVIR-NATRIUM-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/14/983 20150115
2340029	PA2015011,C2340029	Lithuania		PRODUCT NAME: PARITAPREVIRAS; REGISTRATION NO/DATE: EU/1/14.982 20150115
2692346	CR 2017 00049	Denmark		PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728