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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Colorcon
Express Scripts
Farmers Insurance
Queensland Health
Medtronic
Dow
Mallinckrodt
US Army

Generated: July 21, 2018

DrugPatentWatch Database Preview

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 bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate freedom to operate?

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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate has three hundred and seventy-one patent family members in sixty-three 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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
5,210,085 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Sign Up
5,276,151 Method of synthesis of 1,3-dioxolane nucleosides ➤ Sign Up
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
073 Luxembourg ➤ Sign Up 91073, EXPIRES: 20160131
2016000024 Germany ➤ Sign Up PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2016009 Lithuania ➤ Sign Up PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
2016009,C1301519 Lithuania ➤ Sign Up PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Baxter
Dow
McKesson
US Department of Justice
Express Scripts
Cerilliant
Cipla
Johnson and Johnson

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.