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Last Updated: October 26, 2021

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Tenofovir alafenamide fumarate - Generic Drug Details

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What are the generic sources for tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tenofovir alafenamide fumarate has one hundred and thirty-two patent family members in forty-nine countries.

There are forty-two drug master file entries for tenofovir alafenamide fumarate. One supplier is listed for this compound.

Recent Clinical Trials for tenofovir alafenamide fumarate

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

SponsorPhase
THOMAS STEHL/ HENRI MONDOR HOSPITAL-Department of NephrologyPhase 4
LAMBERT ASSOUMOU/ UNITE 1136 INSERMPhase 4
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaPhase 4

See all tenofovir alafenamide fumarate clinical trials

Paragraph IV (Patent) Challenges for TENOFOVIR ALAFENAMIDE FUMARATE
Tradename Dosage Ingredient NDA Submissiondate
VEMLIDY TABLET;ORAL tenofovir alafenamide fumarate 208464 2019-11-05

US Patents and Regulatory Information for 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 VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for tenofovir alafenamide fumarate

Country Patent Number Estimated Expiration
Japan 6280162 ⤷  Free Forever Trial
European Patent Office 1301519 ⤷  Free Forever Trial
Turkey 200300055 ⤷  Free Forever Trial
Cyprus 1116523 ⤷  Free Forever Trial
New Zealand 535408 ⤷  Free Forever Trial
Spain 2627903 ⤷  Free Forever Trial
European Patent Office 2744810 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for tenofovir alafenamide fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 CR 2012 00021 Denmark ⤷  Free Forever Trial PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2924034 LUC00114 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126
1419152 132012902054377 Italy ⤷  Free Forever Trial PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1663240 15C0073 France ⤷  Free Forever Trial PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2487166 93354 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ALAFENAMIDE DE TENOFOVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE D'ALAFENAMIDE DE TENOFOVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1061
1663240 300850 Netherlands ⤷  Free Forever Trial PRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240 1690061-5 Sweden ⤷  Free Forever Trial PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
McKesson
Moodys
Medtronic
McKinsey

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