Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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

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What are the generic 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 ten 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 twenty patent family members in sixty-four countries.

One supplier is listed for this compound.

Summary for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate
Recent Litigation for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Identify potential future generic entrants

District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd.2018-05-18

See all bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate litigation

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   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 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
>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
0513200 C00513200/01 Switzerland   Start Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
2822954 33/2018 Austria   Start Trial PRODUCT NAME: BICTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 (MITTEILUNG) 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
0513200 91073 Luxembourg   Start Trial 91073, EXPIRES: 20160131
1301519 C01301519/01 Switzerland   Start Trial PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016
>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 verifification 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.