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Last Updated: January 27, 2023

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 six drug master file entries for tenofovir alafenamide fumarate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for tenofovir alafenamide fumarate

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

SponsorPhase
Gilead SciencesPhase 1
Radboud University Medical CenterPhase 1
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A

See all tenofovir alafenamide fumarate clinical trials

Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE FUMARATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 25MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for TENOFOVIR ALAFENAMIDE FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VEMLIDY Tablets tenofovir alafenamide fumarate 25 mg 208464 6 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 Title Estimated Expiration
Eurasian Patent Organization 004926 ПРОЛЕКАРСТВЕННЫЕ СОЕДИНЕНИЯ ФОСФОНАТНЫХ АНАЛОГОВ НУКЛЕОТИДОВ (ВАРИАНТЫ), СПОСОБ ИХ ПОЛУЧЕНИЯ, СПОСОБ СКРИНИНГА ДЛЯ ИХ ИДЕНТИФИКАЦИИ И СОДЕРЖАЩАЯ ИХ КОМПОЗИЦИЯ, СПОСОБ АНТИВИРУСНОЙ ТЕРАПИИ ИЛИ ПРОФИЛАКТИКИ (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES, METHOD FOR METHOD FOR SCREENING TO IDENTIFY THEREOF, METHOD FOR ANTI-VIRAL THERAPY OR PROPHYLAXIS) See Plans and Pricing
Portugal 2744810 See Plans and Pricing
Peru 20141328 TENOFOVIR ALAFENAMIDA HEMIFUMARATO See Plans and Pricing
South Korea 20030022295 See Plans and Pricing
Japan 2004504402 See Plans and Pricing
European Patent Office 2682397 Promédicaments d'analogues de nucléotides phosphonatés et procédés permettant de sélectionner et fabriquer ceux-ci (Prodrugs of phosphonate nucleotide analogues and methods for selecting and making same) See Plans and Pricing
South Korea 100749160 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tenofovir alafenamide fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1301519 16C0013 France See Plans and Pricing PRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2487166 CA 2017 00004 Denmark See Plans and Pricing PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
1663240 132016000129162 Italy See Plans and Pricing PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623
1419152 22/2012 Austria See Plans and Pricing PRODUCT NAME: KOMBINATION VON RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBAREN ADDITIONSSALZEN VON RILPIVIRIN, EINSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1301519 122016000024 Germany See Plans and Pricing PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
1632232 PA2016043 Lithuania See Plans and Pricing PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240 59/2015 Austria See Plans and Pricing PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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