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Tenofovir disoproxil fumarate - Generic Drug Details

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

Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Apotex Inc, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Laurus Labs Pvt, Macleods Pharms Ltd, Mylan Pharms Inc, Qilu Pharm Co Ltd, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tenofovir disoproxil fumarate has eighty-seven patent family members in twenty-two countries.

There are forty-two drug master file entries for tenofovir disoproxil fumarate. Seventeen suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for tenofovir disoproxil fumarate

International Patents:	87
US Patents:	4
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	42
Suppliers / Packagers:	17
Bulk Api Vendors:	71
Clinical Trials:	293
Patent Applications:	2,907
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for tenofovir disoproxil fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tenofovir disoproxil fumarate
DailyMed Link:	tenofovir disoproxil fumarate at DailyMed

Pharmacology for tenofovir disoproxil 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 disoproxil fumarate

(R)-(((((1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphoryl)bis(oxy))bis(methylene) diisopropyl bis(carbonate) fumarate

(R)-5-((2-(6-Amino-9H-purin-9-yl)-1-methylethoxy)methyl)-2,4,6,8-tetraoxa-5-phosphanonanedioic acid, bis(1-methylethyl) ester, 5-oxide, (E)-2-butenedioate (1:1)

[[(1R)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methyl-(isopropoxycarbonyloxymethoxy)phosphoryl]oxymethyl isopropyl carbonate; fumaric acid

[[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate; (E)-but-2-enedioic acid

[[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate;(E)-but-2-enedioic acid

202138-50-9

9-((R)-2-((bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine fumarate

9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine fumarate (1:1)

9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine, fumarate

9-((R)-2-((bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine,fumarate

AB0020710

AB2000088

AC1O4QO8

ACN-028819

AK-51342

AKOS016340707

AKOS025149493

AM20090676

AOB5580

AT-15317

BCP0726000258

bis({[(propan-2-yloxy)carbonyl]oxy}methyl) ({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)phosphonate (2E)-but-2-enedioate

Bis(hydroxymethyl) (((R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phosphonate, bis(isopropyl carbonate) (ester), fumarate (1:1)

C19H30N5O10P.C4H4O4

CHEBI:63718

CHEMBL1486

CS-1346

CT0141

D01982

EX-A590

FT-0082876

fumaric acid bis[(isopropoxycarbonyl)oxy]methyl {[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxy}methanephosphonate

GS 4331-05

GS-4331-05

GS-US-104-0321

GSK-548470

HSDB 7165

HY-13782

I06-1886

KB-60712

KS-1246

LS-173814

MLS004774141

MolPort-009-679-412

MolPort-039-010-541

OTT9J7900I

Q-201788

RP17795

RTR-009415

s1400

SC-24733

SCHEMBL2670560

SCHEMBL40021

SMR003500786

ST2413816

Tenofovir (Disoproxil Fumarate)

Tenofovir DF

Tenofovir disoproxil fumarate (JAN/USAN)

Tenofovir Disoproxil Fumarate [USAN]

Tenofovir disoproxil fumarate, >=98% (HPLC)

Tenofovir disoproxil fumarate, 98%

Tenofovir disoproxil fumarate, Pharmaceutical Secondary Standard; Certified Reference Material

tenofovir-disoproxil-fumarate

TR-009415

UNII-OTT9J7900I

V1698

VCMJCVGFSROFHV-WZGZYPNHSA-N

Viread

Tentative approvals for TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET; ORAL
		300MG	TABLET; ORAL
		300MG	TABLET; ORAL

US Patents and Regulatory Information for tenofovir disoproxil 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	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	AB	RX	Yes	Yes
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	AB	RX	Yes	No
Cipla	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	078800-001	Jan 26, 2018	AB	RX	No	No
Aurobindo Pharma Ltd	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090647-004	Jan 26, 2018	AB	RX	No	No
Strides Pharma	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090742-001	Jan 26, 2018	AB	RX	No	No
Aurobindo Pharma Ltd	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090647-003	Jan 26, 2018	AB	RX	No	No

Expired US Patents for tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012

International Patents for tenofovir disoproxil fumarate

Country	Patent Number	Estimated Expiration
Denmark	1243590
Portugal	1243590
Slovenia	1243590
Australia	756793
Japan	4173202
Luxembourg	91178

Supplementary Protection Certificates for tenofovir disoproxil fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	60/2015	Austria		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1632232	PA2016043	Lithuania		PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152	12C0036	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
1663240	CA 2016 00063	Denmark		PRODUCT NAME: RILPIVIRINHYDROCHLORID OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
0915894	05C0032	France		PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
0915894	91178	Luxembourg		91178, EXPIRES: 20200221