TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

What are the generic drug sources for tenofovir alafenamide fumarate and what is the scope of patent protection?

Tenofovir alafenamide fumarate is the generic ingredient in two branded drugs marketed by Lupin Ltd and Gilead Sciences Inc, and is included in two 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.

Summary for TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	132
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	81
Patent Applications:	1,368
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
Chiang Mai University, Thailand	Phase 3
ANRS, Emerging Infectious Diseases	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3

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
Lupin Ltd	TENOFOVIR ALAFENAMIDE	tenofovir alafenamide fumarate	TABLET;ORAL	214226-001	Mar 30, 2023	AB	RX	No	No
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	AB	RX	Yes	Yes					Y

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
Australia	2014271320	TENOFOVIR ALAFENAMIDE HEMIFUMARATE
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)
European Patent Office	2744810	HÉMIFUMARATE DE TÉNOFOVIR ALAFÉNAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Croatia	P20161696
European Patent Office	1301519	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)
Chile	2014000370	Hemifumarato de tenofovir alafenamida; metodo de preparación; composicion farmaceutica que lo comprende; metodo para preparar la composicion farmaceutica; y uso en el tratamiento de una infeccion por hiv.

Supplementary Protection Certificates for TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	1990024-0	Sweden		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
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
1632232	SPC/GB17/008	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1632232	PA2016043	Lithuania		PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240	375 5032-2016	Slovakia		PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/EMTRICITABIN/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2924034	300981	Netherlands		PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126