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Last Updated: November 22, 2024

TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details


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

Tenofovir alafenamide fumarate is the generic ingredient in three branded drugs marketed by Lupin Ltd, Apotex, and Gilead Sciences Inc, and is included in three NDAs. There are three 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 fifty 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
Chiang Mai University, ThailandPhase 3
ANRS, Emerging Infectious DiseasesPhase 3
Assistance Publique - Hôpitaux de Paris, FRANCEPhase 3

See all TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 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 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex TENOFOVIR ALAFENAMIDE FUMARATE tenofovir alafenamide fumarate TABLET;ORAL 213867-001 Mar 21, 2024 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Lupin Ltd TENOFOVIR ALAFENAMIDE tenofovir alafenamide fumarate TABLET;ORAL 214226-001 Mar 30, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464-001 Nov 10, 2016 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Ukraine 75889 ПРОЛЕКАРСТВА АНАЛОГОВ ФОСФОНАТНУКЛЕОТИДА, СПОСОБ ИХ СЕЛЕКЦИИ И ПОЛУЧЕНИЯ;ПРОЛІКИ АНАЛОГІВ ФОСФОНАТНУКЛЕОТИДУ, СПОСІБ ЇХ СЕЛЕКЦІЇ ТА ОДЕРЖАННЯ (PHOSPHONATNUCLEOTIDE ANALOGS PRODRUGS, A METHOD FOR SELECTION AND PREPARATION THEREOF) ⤷  Sign Up
African Regional IP Organization (ARIPO) 3639 TENOFOVIR ALAFENAMIDE HEMIFUMARATE ⤷  Sign Up
Poland 213214 ⤷  Sign Up
Denmark 2744810 ⤷  Sign Up
Ukraine 115311 ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) ⤷  Sign Up
Canada 2416757 PROMEDICAMENTS A BASE D'ANALOGUES NUCLEOTIDIQUES DE PHOSPHONATE ET LEURS METHODES DE SELECTION ET D'ELABORATION (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME) ⤷  Sign Up
Israel 153658 ⤷  Sign Up
>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 SPC/GB16/015 United Kingdom ⤷  Sign Up 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
1663240 132016000024787 Italy ⤷  Sign Up PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, TENOFOVIR, IN PARTICOLARE TENOFOVIR DISOPROXIL FUMARATO E EMITRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
2487166 2017003 Norway ⤷  Sign Up PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209
1419152 22/2012 Austria ⤷  Sign Up 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
0915894 08C0020 France ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1663240 122016000109 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240 PA2016044 Lithuania ⤷  Sign Up PRODUCT NAME: RILPIVIRINAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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