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Last Updated: December 6, 2019

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

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

Cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate has six hundred and thirty-nine patent family members in fifty-nine countries.

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

Recent Litigation for cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate

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District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
JANSSEN PRODUCTS, L.P. v. AMNEAL PHARMACEUTICALS, LLC2018-12-26
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27

See all cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate litigation

PTAB Litigation
PetitionerDate
Lupin Limited2015-04-09

See all cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate litigation

US Patents and Regulatory Information for cobicistat; darunavir ethanolate; 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 ethanolate; 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 ethanolate; 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 ethanolate; 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 ethanolate; 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 ethanolate; 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 ethanolate; 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 ethanolate; emtricitabine; tenofovir alafenamide fumarate

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487162 300861 Netherlands   Start Trial PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
2049506 61/2015 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
2487163 17C1000 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487166 59/2016 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123
2487163 1790002-8 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
2487163 300859 Netherlands   Start Trial PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Harvard Business School
McKesson
Mallinckrodt
Medtronic

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