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Generated: June 21, 2018

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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, 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 ten 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 thirty-nine drug master file entries for tenofovir disoproxil fumarate. Fourteen suppliers are listed for this compound. There are nine tentative approvals for this compound.
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
➤ Sign Up➤ Sign Up300MGTABLET; ORAL
➤ Sign Up➤ Sign Up300MGTABLET; ORAL
➤ Sign Up➤ Sign Up300MGTABLET; 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
Aurobindo Pharma Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-002 Jan 26, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-003 Jan 26, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 091612-003 Jan 26, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 091612-002 Jan 26, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate POWDER;ORAL 022577-001 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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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 ➤ Sign Up
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for tenofovir disoproxil fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021 France ➤ Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
2016043 Lithuania ➤ Sign Up PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2015000088 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
C/GB08/022 United Kingdom ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
QuintilesIMS
Cerilliant
Dow
Harvard Business School
AstraZeneca
Argus Health
McKesson
Federal Trade Commission

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