VIEKIRA PAK (COPACKAGED) Drug Patent Profile

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Which patents cover Viekira Pak (copackaged), and when can generic versions of Viekira Pak (copackaged) launch?

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

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

The generic ingredient in VIEKIRA PAK (COPACKAGED) 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 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 ten 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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Summary for VIEKIRA PAK (COPACKAGED)

International Patents:	621
US Patents:	17
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	22
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIEKIRA PAK (COPACKAGED)
DailyMed Link:	VIEKIRA PAK (COPACKAGED) at DailyMed

Drug patent expirations by year for VIEKIRA PAK (COPACKAGED)

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

Generic Entry Date for VIEKIRA PAK (COPACKAGED)^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

US Patents and Regulatory Information for VIEKIRA PAK (COPACKAGED)

VIEKIRA PAK (COPACKAGED) is protected by seventeen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIEKIRA PAK (COPACKAGED) is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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)

Formulations of pyrimidinedione derivative compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR

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

Solid pharmaceutical dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Macrocyclic hepatitis C serine protease inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods for treating HCV
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.

Macrocyclic hepatitis C serine protease inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR

Solid compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Anti-viral compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Anti-viral compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HCV INFECTION USING OMBITASVIR

Compositions and methods for treating HCV
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HCV INFECTION USING PARITAPREVIR

Anti-infective agents and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR

Formulations of pyrimidinedione derivative compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HCV INFECTION USING DASABUVIR

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 PAK (COPACKAGED)

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

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

Patent: 13330993
Patent: Formulations of pyrimidinedione derivative compounds
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2015008927
Patent: formulações de compostos derivados de pirimidinadiona
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 88883
Patent: FORMULATIONS DE COMPOSES DERIVES DE PYRIMIDINEDIONE (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 4853752
Patent: Formulations of pyrimidinedione derivative compounds
Estimated Expiration: ⤷ Sign Up

Patent: 9260207
Patent: 嘧啶二酮衍生物化合物的制剂 (Formulations of pyrimidinedione derivative compounds)
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 8481
Patent: ПРЕПАРАТЫ ПРОИЗВОДНЫХ ПИРИМИДИНДИОНА (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Patent: 2913
Patent: ПРЕПАРАТЫ ПРОИЗВОДНЫХ ПИРИМИДИНДИОНА (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Patent: 1590752
Patent: ПРЕПАРАТЫ ПРОИЗВОДНЫХ ПИРИМИДИНДИОНА
Estimated Expiration: ⤷ Sign Up

Patent: 1791354
Patent: ПРЕПАРАТЫ ПРОИЗВОДНЫХ ПИРИМИДИНДИОНА
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 08808
Patent: FORMULATIONS DE COMPOSÉS DÉRIVÉS DE PYRIMIDINEDIONE (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 66635
Estimated Expiration: ⤷ Sign Up

Patent: 15534985
Patent: ピリミジンジオン誘導体化合物の製剤
Estimated Expiration: ⤷ Sign Up

Patent: 18065858
Patent: ピリミジンジオン誘導体化合物の製剤 (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 15004973
Patent: FORMULACIONES DE COMPUESTOS DERIVADOS DE PIRIMIDINDIONA. (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS.)
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201503051Q
Patent: FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
China	108350016	抗病毒四氢呋喃衍生物 (Anti-viral tetrahydrofurane derivatives)	⤷ Sign Up
Ukraine	113048	ПРОТИВІРУСНІ СПОЛУКИ	⤷ Sign Up
Slovenia	2628481		⤷ Sign Up
European Patent Office	2692346	Dérivé antiviraux de 2,5-dibenzimidazol-5-yl-1-phényl-pyrrolidine (An antiviral 1-phenyl-2,5-dibenzimidazol-5-yl-pyrrolidine derivative)	⤷ Sign Up
Hungary	S1500019		⤷ Sign Up
Spain	2523864		⤷ Sign Up
European Patent Office	1210941		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	122015000040	Germany	⤷ Sign Up	PRODUCT NAME: DASABUVIR; REGISTRATION NO/DATE: EU/1/14/983 20150115
2692346	C02692346/01	Switzerland	⤷ Sign Up	FORMER OWNER: ABBVIE BAHAMAS LTD., BS
2692346	2017/046	Ireland	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2368890	CR 2015 00015	Denmark	⤷ Sign Up	PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150119
2340029	599	Finland	⤷ Sign Up
2692346	PA2017033	Lithuania	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2340029	92667	Luxembourg	⤷ Sign Up	PRODUCT NAME: PARITAPREVIR, OU UN SEL OU ESTER PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (VIEKIRAX). FIRST REGISTRATION: 20150119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description