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Last Updated: November 22, 2024

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details


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What are the generic drug sources for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate has five hundred and twenty-six patent family members in fifty-six countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Generic Entry Date for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE*:
Constraining patent/regulatory exclusivity:
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 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

SponsorPhase
Gilead SciencesPhase 1/Phase 2
University of California, Los AngelesPhase 1/Phase 2
Brigham and Women's HospitalN/A

See all COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Paragraph IV (Patent) Challenges for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
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 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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
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

Expired US Patents for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Country Patent Number Title Estimated Expiration
Portugal 1636190 ⤷  Sign Up
Portugal 2393485 ⤷  Sign Up
South Africa 200610647 Stable crystal of 4-oxoquinoline compound ⤷  Sign Up
Poland 213214 ⤷  Sign Up
Canada 2566922 CRISTAL STABLE DE COMPOSE 4-OXOQUINOLINE (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND) ⤷  Sign Up
European Patent Office 3287130 COMBINAISONS COMPORTANT UN DÉRIVÉ D'ISOQUINOLONE 4 ET INHIBITEURS DE LA PROTEASE (COMBINATIONS COMPRISING A 4-ISOQUINOLONE DERIVATIVE AND PROTEASE INHIBITORS) ⤷  Sign Up
Cyprus 2020011 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487166 132017000002828 Italy ⤷  Sign Up PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
3150586 PA2020508 Lithuania ⤷  Sign Up PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487166 2017003 Norway ⤷  Sign Up PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209
2487163 PA2016039,C2487163 Lithuania ⤷  Sign Up PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA IR ATAZANAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC ATAZANAVIRO SULFATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
1564210 1390052-7 Sweden ⤷  Sign Up PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26
2487163 C20170001 00217 Estonia ⤷  Sign Up PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2487163 60/2016 Austria ⤷  Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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