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Last Updated: August 7, 2020

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Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

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

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Janssen Prods 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; darunavir; emtricitabine; tenofovir alafenamide fumarate has six hundred and twenty-five patent family members in fifty-nine countries.

There are five drug master file entries for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate. One supplier is listed for this compound.

Summary for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate
International Patents:625
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 5
Suppliers / Packagers: 1
Clinical Trials: 3
DailyMed Link:cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate at DailyMed
Recent Clinical Trials for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

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

SponsorPhase
Janssen Sciences Ireland UCPhase 3
Janssen R&D IrelandPhase 3
Gilead SciencesPhase 2

See all cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate clinical trials

US Patents and Regulatory Information for cobicistat; darunavir; 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
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 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 cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Supplementary Protection Certificates for cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487162 93352 Luxembourg   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVAT DE CELUI-CI ET DARUNAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SPLVAT DE CELUI-CI, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967
2049506 2015/058 Ireland   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-EU/1/13/830/002 20130524
2049506 300780 Netherlands   Start Trial PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487166 122016000104 Germany   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
3150586 PA2020508 Lithuania   Start Trial 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
2487162 CA 2017 00002 Denmark   Start Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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