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Last Updated: August 8, 2020

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GENVOYA Drug Profile

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

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 sixty-four 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.

US ANDA Litigation and 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 4, 2032. This may change due to patent challenges or generic licensing.

There have been seventeen 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

See drug prices for GENVOYA

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   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 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 GENVOYA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015   Start Trial   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GENVOYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1564210 92307 Luxembourg   Start Trial PRODUCT NAME: ELVIEGRAVIR SOUS TOUTES SES FORMES COMME PROTEGEES PAR LE BREVET DE BASE
0513200 122004000015 Germany   Start Trial PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
1564210 13C0061 France   Start Trial PRODUCT NAME: ELVITEGRAVIR OU UN HYDRATE, SOLVATE, TAUTOMERE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CEUX-CI; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
1301519 C 2016 011 Romania   Start Trial PRODUCT NAME: TENOFOVIR ALAFENAMIDA SAU O SARE SAU SOLVAT AL ACESTUIA, IN SPECIAL FUMARAT DE TENOFOVIR ALAFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1061/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1061/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20151119
2487163 122016000120 Germany   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE ATAZANAVIRSULFAT; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2487162 132017000002735 Italy   Start Trial PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.