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Last Updated: January 22, 2021

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Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

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What are the generic drug sources for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate and what is the scope of patent protection?

Bictegravir sodium; 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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate has four hundred and eighty-six patent family members in sixty-four countries.

One supplier is listed for this compound.

Summary for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

US Patents and Regulatory Information for bictegravir sodium; 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 BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822954 2018026 Norway   Start Trial PRODUCT NAME: BICTEGRAVIR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER/DATE: NO, EU/1/18/1289, BIKTARVY, 20180625
1301519 SPC/GB16/015 United Kingdom   Start Trial PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123
2822954 C20180024 00269 Estonia   Start Trial PRODUCT NAME: BIKTEGRAVIIR;REG NO/DATE: EU/1/18/1289 25.06.2018
1301519 132016000035069 Italy   Start Trial PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
2822954 LUC00083 Luxembourg   Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
AstraZeneca

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