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Last Updated: August 8, 2020

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VIEKIRA PAK (COPACKAGED) Drug 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 Inc and is included in one NDA. There are eighteen patents protecting this drug.

This drug has six hundred and seven 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.

US ANDA Litigation and 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 fourteen 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 PAK (COPACKAGED)
Generic Entry Opportunity Date for VIEKIRA PAK (COPACKAGED)
Generic Entry Date for VIEKIRA PAK (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
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)

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, TABLET;ORAL 206619-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir; paritaprevir; ritonavir TABLET, TABLET;ORAL 206619-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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)

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

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340029 C20150019 00156 Estonia   Start Trial PRODUCT NAME: PARITAPREVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2340029 599 Finland   Start Trial
2203431 1590018-6 Sweden   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2692346 122017000074 Germany   Start Trial PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2340029 122015000042 Germany   Start Trial PRODUCT NAME: PARITAPREVIR; REGISTRATION NO/DATE: EU/1/14/982 20150115
2368890 15C0016 France   Start Trial PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2368890 CA 2015 00015 Denmark   Start Trial PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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