VIEKIRA PAK (COPACKAGED) Drug Patent Profile

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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 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
Lithuania	C2368890		⤷ Sign Up
Japan	2020059696	抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS)	⤷ Sign Up
Japan	2010539187		⤷ Sign Up
Mexico	2020002151	COMPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)	⤷ Sign Up
Turkey	201809084		⤷ Sign Up
Taiwan	I586660		⤷ Sign Up
Argentina	077411	FORMA DE DOSIFICACION FARMACEUTICA SOLIDA, CON LOPINAVIR Y RITONAVIR, Y PROCESO PARA SU PREPARACION.	⤷ 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
2368890	15C0016	France	⤷ Sign Up	PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2692346	122017000074	Germany	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2692346	CR 2017 00049	Denmark	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2692346	17C1040	France	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2203431	PA2015013	Lithuania	⤷ Sign Up	PRODUCT NAME: DASABUVIRUM; REGISTRATION NO/DATE: EU/1/14/983 20150115
2692346	2017/046	Ireland	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2692346	1790050-7/1791051-4	Sweden	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description