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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 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:	40
Suppliers / Packagers:	1
Bulk Api Vendors:	44
Clinical Trials:	34
Patent Applications:	66
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

Ingredient-type	Nucleoside Analog
Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Hepatitis B 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
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
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016		RX	Yes	Yes			Y	Y

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International Patents for tenofovir alafenamide fumarate

Country	Document Number	Estimated Expiration
Eurasian Patent Organization	200300188
European Patent Office	2682397
Poland	2744810
Norway	20150909
Iceland	2985
Netherlands	300803

Supplementary Protection Certificates for tenofovir alafenamide fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/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
2016000024	Germany		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
C/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
2016 00065	Denmark		PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
C0073	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0860	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123