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Generated: October 19, 2018

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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.

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.

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
Teva Pharms Usa TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 091612-004 Jan 26, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 AB RX Yes 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 TABLET;ORAL 021356-002 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
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-002 Jan 18, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for tenofovir disoproxil fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894/02 Switzerland ➤ Sign Up PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
2016009 Lithuania ➤ Sign Up PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
6 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Merck
Chinese Patent Office
Teva
Farmers Insurance
Johnson and Johnson
Chubb
McKinsey
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.