Tenofovir alafenamide fumarate - Generic Drug Details

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

See all tenofovir alafenamide fumarate clinical trials

Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Application No.	Strength	Dosage Form
		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

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

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
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes

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

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)
Portugal	2744810
Peru	20141328	TENOFOVIR ALAFENAMIDA HEMIFUMARATO
South Korea	20030022295
Japan	2004504402
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)
South Korea	100749160

Supplementary Protection Certificates for tenofovir alafenamide fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	16C0013	France		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		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		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		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		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
1632232	PA2016043	Lithuania		PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240	59/2015	Austria		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