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Tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic drug sources for tenofovir disoproxil fumarate and what is the scope of tenofovir disoproxil fumarate freedom to operate?

Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd Iii, Laurus Labs Pvt, Macleods Pharms Ltd, Qilu Pharm Co Ltd, Strides Pharma, and Teva Pharms Usa, and is included in eleven 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 drug master file entries for tenofovir disoproxil fumarate. Fourteen 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:	10
NDAs:	11
Drug Master File Entries:	40
Suppliers / Packagers:	14
Bulk Api Vendors:	64
Clinical Trials:	277
Patent Applications:	2,831
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

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 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

D0R3FP

EX-A590

FT-0082876

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

FUMARIC ACID; PMPA PRODRUG

GS 4331-05

GS-4331-05

GS-US-104-0321

GSK-548470

GSK548470

HSDB 7165

HY-13782

I06-1886

KB-60712

KS-1246

LS-173814

MLS004774141

MolPort-009-679-412

MolPort-039-010-541

OR077617

OTT9J7900I

PMPA-oral

Q-201788

RP17795

RTR-009415

s1400

SC-24733

SCHEMBL2670560

SCHEMBL40021

SMR003500786

ST2413816

ST51053272

Tenofovir (Disoproxil Fumarate)

Tenofovir DF

Tenofovir disoproxil fumarate (JAN/USAN)

Tenofovir Disoproxil Fumarate [USAN]

Tenofovir disoproxil fumarate, >=98% (HPLC)

tenofovir-disoproxil-fumarate

Tenofovirdisoproxilfumarate

Tenozet

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
Laurus Labs Pvt	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	209550-001	Feb 26, 2018	AB	RX	No	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	AB	RX	Yes	Yes
Teva Pharms Usa	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	091612-004	Jan 26, 2018	AB	RX	No	No

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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	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	021356-001	Oct 26, 2001

Non-Orange Book US Patents for tenofovir disoproxil fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,069,249	Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
RE38333	Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability

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International Patents for tenofovir disoproxil fumarate

Country	Document Number	Estimated Expiration
Japan	4033494
World Intellectual Property Organization (WIPO)	9804569
Germany	122005000041

Supplementary Protection Certificates for tenofovir disoproxil fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016000024	Germany		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2016 00064	Denmark		PRODUCT NAME: RILPIVIRINHYDROCHLORID, EMTRICITABIN OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
433	Luxembourg		91433, EXPIRES: 20220725