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Last Updated: March 29, 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 nineteen patents protecting this drug.

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

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 eighteen 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.

Recent Litigation for VIEKIRA PAK (COPACKAGED)

Identify potential future generic entrants

District Court Litigation
Case NameDate
AbbVie Inc. v. Cipla Limited2017-11-10
AbbVie Inc. v. Aurobindo Pharma Limited2017-01-13
AbbVie Inc. v. Amneal Pharmaceuticals, LLC2016-05-27

See all VIEKIRA PAK (COPACKAGED) litigation

Synonyms for VIEKIRA PAK (COPACKAGED)
Dasabuvir / ombitasvir / paritaprevir / ritonavir
Dasabuvir combination with ombitasvir, paritaprevir and ritonavir
Ombitasvir, dasabuvir, paritaprevir, and ritonavir
S900006810
Viekira Pak
Viekira Xr

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   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 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   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
2203431 92666 Luxembourg   Start Trial PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431 C02203431/01 Switzerland   Start Trial FORMER OWNER: ABBVIE BAHAMAS LIMITED, BS
2368890 92668 Luxembourg   Start Trial PRODUCT NAME: OMBITASVIR, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (VIEKIRAX R); FIRST REGISTRATION DATE: 20150119
2340029 PA2015011,C2340029 Lithuania   Start Trial PRODUCT NAME: PARITAPREVIRAS; REGISTRATION NO/DATE: EU/1/14.982 20150115
2368890 C20150016 00154 Estonia   Start Trial PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2368890 33/2015 Austria   Start Trial PRODUCT NAME: OMBITASVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/982 (MITTEILUNG) 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Merck
Express Scripts
McKesson
AstraZeneca

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