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Last Updated: January 23, 2020

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VOSEVI Drug Profile

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Which patents cover Vosevi, and what generic alternatives are available?

Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are fifteen patents protecting this drug.

This drug has five hundred and seventeen patent family members in forty-eight countries.

The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.

US ANDA Litigation and Generic Entry Outlook for Vosevi

Vosevi will be eligible for patent challenges on June 28, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 17, 2034. This may change due to patent challenges or generic licensing.

There have been five 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 VOSEVI
Drug Prices for VOSEVI

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Generic Entry Opportunity Date for VOSEVI
Generic Entry Date for VOSEVI*:
Constraining patent/regulatory exclusivity:

*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 Clinical Trials for VOSEVI

Identify potential brand extensions & 505(b)(2) entrants

Partners in HealthPhase 4

See all VOSEVI clinical trials

Recent Litigation for VOSEVI

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc.2018-03-27
Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc.2014-07-01

See all VOSEVI litigation

PTAB Litigation
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.2017-12-26
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.2017-11-09
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.2017-11-02

See all VOSEVI litigation

Synonyms for VOSEVI
Sofosbuvir / velpatasvir / voxilaprevir
Sofosbuvir mixture with velpatasvir and voxilaprevir

US Patents and Regulatory Information for VOSEVI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes   Start Trial   Start Trial Y 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

Supplementary Protection Certificates for VOSEVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 CA 2014 00061 Denmark   Start Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2203462 C300704 Netherlands   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 C20140035 00135 Estonia   Start Trial PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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