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.
Summary for tenofovir alafenamide fumarate
International Patents: | 132 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 77 |
Patent Applications: | 1,549 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tenofovir alafenamide fumarate |
DailyMed Link: | tenofovir alafenamide fumarate at DailyMed |
Recent Clinical Trials for tenofovir alafenamide fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Gilead Sciences | Phase 1 |
Radboud University Medical Center | Phase 1 |
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | N/A |
Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE FUMARATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 25MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology 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
Expired US Patents for tenofovir alafenamide fumarate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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