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Last Updated: June 13, 2021

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GENVOYA Drug Profile


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Which patents cover Genvoya, and when can generic versions of Genvoya launch?

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

This drug has six hundred and seventy-six patent family members in sixty countries.

The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Genvoya

Genvoya was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 6, 2032. This may change due to patent challenges or generic licensing.

There have been sixteen 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 GENVOYA
Drug Prices for GENVOYA

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for GENVOYA
Generic Entry Date for GENVOYA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
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 Clinical Trials for GENVOYA

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

SponsorPhase
Henry M. Jackson Foundation for the Advancement of Military MedicineN/A
Johns Hopkins UniversityPhase 4
Canadian Institutes of Health Research (CIHR)Phase 2

See all GENVOYA clinical trials

US Patents and Regulatory Information for GENVOYA

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 GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 GENVOYA

Supplementary Protection Certificates for GENVOYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487162 122016000103 Germany   Get Started Free PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
0513200 C00513200/01 Switzerland   Get Started Free PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1564210 C 2013 033 Romania   Get Started Free PRODUCT NAME: ELVITEGRAVIR OPTIONAL SUB FORMA DE SARE, SOLVAT SAU HIDRATACCEPTABILFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001, EU/1/13/830/002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001, EU/1/13/830/002; DATE OF FIRST AUTHORISATION IN EEA: 20130524
2049506 C20150046 Estonia   Get Started Free PRODUCT NAME: KOBITSISTAAT; AUTHORISATION NO.: EMA/CHMP/596576/2017, AUTORISATION DATE: 20170914
1564210 203 5022-2013 Slovakia   Get Started Free PRODUCT NAME: ELVITEGRAVIR ALEBO JEHO HYDRAT, SOLVAT, TAUTOMER ALEBO FARMACEUTICKY PRIJATELNA SOL; NAT. REGISTRATION NO/DATE: EU/1/13/830/001 - EU/1/13/830/002 20130527; FIRST REGISTRATION: EU EU/1/13/830/001 - EU/1/13/830/002 20130527
3150586 LUC00156 Luxembourg   Get Started Free PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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