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Last Updated: June 2, 2024

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GENVOYA Drug Patent 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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and twenty-six patent family members in fifty-six countries.

The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is 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 April 6, 2033. This may change due to patent challenges or generic licensing.

There have been twenty-three 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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Summary for GENVOYA
International Patents:526
US Patents:10
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 19
Formulation / Manufacturing:see details
Drug Prices: Drug price information for GENVOYA
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for GENVOYA
What excipients (inactive ingredients) are in GENVOYA?GENVOYA excipients list
DailyMed Link:GENVOYA at DailyMed
Drug patent expirations by year for GENVOYA
Drug Prices for GENVOYA

See drug prices for GENVOYA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GENVOYA
Generic Entry Date for GENVOYA*:
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Constraining patent/regulatory exclusivity:
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NDA:
207561
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
Unity Health TorontoPhase 2
Canadian Institutes of Health Research (CIHR)Phase 2
St. Michael's Hospital, TorontoPhase 2

See all GENVOYA clinical trials

Pharmacology for GENVOYA
Drug ClassCytochrome P450 3A Inhibitor
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of ActionBreast Cancer Resistance Protein Inhibitors
Cytochrome P450 2C9 Inducers
Cytochrome P450 2D6 Inhibitors
Cytochrome P450 3A Inhibitors
HIV Integrase Inhibitors
Nucleoside Reverse Transcriptase Inhibitors
Organic Anion Transporting Polypeptide 1B1 Inhibitors
Organic Anion Transporting Polypeptide 1B3 Inhibitors
P-Glycoprotein Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for GENVOYA
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J05AJ Integrase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
V03AX Other therapeutic products
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various
Paragraph IV (Patent) Challenges for GENVOYA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GENVOYA Tablets cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate 150 mg/150 mg/ 200 mg/10 mg 207561 1 2023-04-12

US Patents and Regulatory Information for GENVOYA

GENVOYA is protected by ten US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GENVOYA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting GENVOYA

Use of solid carrier particles to improve the processability of a pharmaceutical agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

4-oxoquinoline compound and use thereof as pharmaceutical agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Combination therapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Glossary
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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International Patents for GENVOYA

When does loss-of-exclusivity occur for GENVOYA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 89
Estimated Expiration: ⤷  Sign Up

Patent: 50
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 5369
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09242451
Estimated Expiration: ⤷  Sign Up

Patent: 10210598
Estimated Expiration: ⤷  Sign Up

Patent: 14221210
Estimated Expiration: ⤷  Sign Up

Patent: 15200637
Estimated Expiration: ⤷  Sign Up

Patent: 16250470
Estimated Expiration: ⤷  Sign Up

Patent: 17201473
Estimated Expiration: ⤷  Sign Up

Patent: 18267573
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0911871
Estimated Expiration: ⤷  Sign Up

Patent: 1008664
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 20856
Estimated Expiration: ⤷  Sign Up

Patent: 50521
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 11001885
Estimated Expiration: ⤷  Sign Up

China

Patent: 2123700
Estimated Expiration: ⤷  Sign Up

Patent: 2307573
Estimated Expiration: ⤷  Sign Up

Patent: 3479584
Estimated Expiration: ⤷  Sign Up

Patent: 4940937
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 21225
Estimated Expiration: ⤷  Sign Up

Patent: 00187
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0151009
Estimated Expiration: ⤷  Sign Up

Patent: 0151357
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16852
Estimated Expiration: ⤷  Sign Up

Patent: 17067
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 10010636
Estimated Expiration: ⤷  Sign Up

Patent: 11011307
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1313
Estimated Expiration: ⤷  Sign Up

Patent: 2950
Estimated Expiration: ⤷  Sign Up

Patent: 0123
Estimated Expiration: ⤷  Sign Up

Patent: 1071173
Estimated Expiration: ⤷  Sign Up

Patent: 1190125
Estimated Expiration: ⤷  Sign Up

Patent: 1491658
Estimated Expiration: ⤷  Sign Up

Patent: 1591353
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

Patent: 06032
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 53670
Estimated Expiration: ⤷  Sign Up

Patent: 64737
Estimated Expiration: ⤷  Sign Up

Patent: 15679
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 25822
Estimated Expiration: ⤷  Sign Up

Patent: 26380
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8614
Estimated Expiration: ⤷  Sign Up

Patent: 4227
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 11242
Estimated Expiration: ⤷  Sign Up

Patent: 22213
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

Patent: 25171
Estimated Expiration: ⤷  Sign Up

Patent: 11522790
Estimated Expiration: ⤷  Sign Up

Patent: 12517432
Estimated Expiration: ⤷  Sign Up

Patent: 14012741
Estimated Expiration: ⤷  Sign Up

Patent: 14221845
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Mexico

Patent: 2377
Estimated Expiration: ⤷  Sign Up

Patent: 10011963
Estimated Expiration: ⤷  Sign Up

Patent: 11008289
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8978
Estimated Expiration: ⤷  Sign Up

Patent: 4214
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 110994
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01500266
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 3544
Estimated Expiration: ⤷  Sign Up

Patent: 0618
Estimated Expiration: ⤷  Sign Up

Patent: 14007744
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Patent: 201609006W
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Patent: 201706215U
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Slovenia

Patent: 96633
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Patent: 93485
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South Africa

Patent: 1008007
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South Korea

Patent: 1645759
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Patent: 1659971
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Patent: 1738325
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Patent: 1784647
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Patent: 110015581
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Patent: 110122729
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Patent: 160093100
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Patent: 160114728
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Spain

Patent: 48886
Estimated Expiration: ⤷  Sign Up

Patent: 53897
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 44367
Estimated Expiration: ⤷  Sign Up

Patent: 1040142
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 1193
Estimated Expiration: ⤷  Sign Up

Patent: 3224
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 424
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering GENVOYA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1564210 COMPOSES 4-OXOQUINOLINIQUES ET LEUR UTILISATION COMME INHIBITEUR DE LA VIH-INTEGRASE (4-OXOQUINOLINE COMPOUNDS AND UTILIZATION THEREOF AS HIV INTEGRASE INHIBITORS) ⤷  Sign Up
Cyprus 1118227 ⤷  Sign Up
Japan 2007246536 USE OF 1-(2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)-5-FLUOROCYTOSINE FOR TREATMENT OF HEPATITIS B ⤷  Sign Up
Czech Republic 295074 (-)-beta-L-2-Hydroxymethyl-5-(5-fluor-1-cytosinyl)-1,3-oxathiolan, farmaceutický prostředek s jeho obsahem a jeho použití ((-)-Beta-L-2-hydroxymethyl-5-(5-fluoro-1-cytosinyl)-1,3-oxathiolate, pharmaceutical preparation containing thereof and its use) ⤷  Sign Up
Hungary E025565 ⤷  Sign Up
Canada 2470365 COMPOSES 4-OXOQUINOLINIQUES ET LEUR UTILISATION COMME INHIBITEUR DE LA VIH-INTEGRASE (4-OXOQUINOLINE COMPOUND AND USE THEREOF AS HIV INTEGRASE INHIBITOR) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for GENVOYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 PA2016039 Lithuania ⤷  Sign Up PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
1564210 C01564210/01 Switzerland ⤷  Sign Up CHANGE OF ADDRESS OF THE OWNER: JAPAN TOBACCO INC., 1-1, TORANOMON 4-CHOME, MINATO-KU, TOKYO 105-6927, JP
2487162 61/2016 Austria ⤷  Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
1564210 CA 2013 00058 Denmark ⤷  Sign Up PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524
1564210 92307 Luxembourg ⤷  Sign Up PRODUCT NAME: ELVITEGRAVIR SOUS TOUTES SES FORMES COMME PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 - STRIBILD-ELVITEGRAVIR/... 20130527
2049506 15C0078 France ⤷  Sign Up PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
>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.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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