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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 tenofovir alafenamide fumarate 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 twenty-four patent family members in forty-eight countries.

There are forty-two drug master file entries for tenofovir alafenamide fumarate. One supplier is listed for this compound.

Summary for tenofovir alafenamide fumarate

International Patents:	124
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	42
Suppliers / Packagers:	1
Bulk Api Vendors:	24
Clinical Trials:	40
Patent Applications:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tenofovir alafenamide fumarate
DailyMed Link:	tenofovir alafenamide fumarate at DailyMed

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

Synonyms for tenofovir alafenamide fumarate

(S)-Isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate

(S)-isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(phenoxy)phosphoryl)amino)propanoate hemifumarate

1-Methylethyl N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinoyl)-L-alaninate, (2E)-2-butenedioate

1392275-56-7

377091-31-1

379270-37-8

383365-04-6

4863AB

9-[(r)-2-[[(s)-[[(s)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine

AJ-67913

AK109983

AKOS016009341

B8021

BC600709

bis{9-[(2R,5S,7E)-2,7,10-trimethyl-5,8-dioxo-5-phenoxy-3,9-dioxa-6-aza-5lambda5-phosphaundecan-1-yl]-9H-purin-6-aminium} (2E)-but-2-enedioate

bis{propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl]-L-alaninate} (2E)-but-2-enedioate

C21H29N6O5P

CHEBI:90923

CHEBI:90926

CHEMBL2107825

CHEMBL2364637

CS-3366

D10428

D10605

DA-42599

DB09299

EL9943AG5J

EX-A610

FT-0700641

FWF6Q91TZO

GS 7340

GS-7339

GS-7340

GS-7340-03

GS-7340; Tenofovir alafenamide

GS-734003

GS7340

HY-15232

isopropyl (2S)-2-[[[(1R)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methyl-phenoxy-phosphoryl]amino]propanoate

J4414G3BUK

KB-77600

KS-00000PWZ

L-Alanine, N-((R)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl ester

L-Alanine, N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl ester

L-Alanine, N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl ester, (2E)-2-butenedioate (2:1)

L-Alanine, N-[(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-, 1-methylethyl ester

L-Alanine, Sp-N-[[[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl]oxy]methyl]phenoxyphosphinyl]-, isopropyl ester

LDEKQSIMHVQZJK-CAQYMETFSA-N

MFCD23843796

MolPort-027-835-280

N-((R)-(((1R)-2-(6-Amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-L-alanine 1-methylethyl ester

propan-2-yl (2S)-2-{[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl]amino}propanoate

propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl]-L-alaninate

S7856

SC-20288

SCHEMBL3107149

Sp-Tenofovir-phosphonamidate, phenyl, L-alanine isopropyl ester

TENOFOVIR ALAFENAMIDE

Tenofovir Alafenamide (GS-7340)

Tenofovir Alafenamide (Prodrug of tenofovir)

Tenofovir alafenamide (USAN/INN)

Tenofovir Alafenamide [USAN:INN]

Tenofovir alafenamide fumarate (USAN/JAN)

Tenofovir Alafenamide fumarate [USAN]

tenofovir alafenamide hemifumarate

tenofovir alagenamide

UNII-EL9943AG5J

UNII-FWF6Q91TZO

UNII-J4414G3BUK

Vemlidy

ZINC100055899

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

International Patents for tenofovir alafenamide fumarate

Country	Document Number	Estimated Expiration
Japan	5651275
Spain	2536972
Australia	2014271320
Uruguay	34262
European Patent Office	1301519
Chile	2014000370

Supplementary Protection Certificates for tenofovir alafenamide fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016042	Lithuania		PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
0767	Netherlands		PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
2016000110	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
C/GB08/022	United Kingdom		PRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
90012-8	Sweden		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061/001-002 20151123
2016 00064	Denmark		PRODUCT NAME: RILPIVIRINHYDROCHLORID, EMTRICITABIN OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623