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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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 patent protection?

Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Apotex Inc, Aurobindo Pharma Ltd, Casi Pharms Inc, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Qilu Pharm Co Ltd, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for tenofovir disoproxil fumarate

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Recent Clinical Trials for tenofovir disoproxil fumarate

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SponsorPhase
Fundacio Lluita Contra la SIDAPhase 2
Hospital Universitari de BellvitgePhase 2
Institut d'Investigació Biomèdica de BellvitgePhase 2

See all tenofovir disoproxil fumarate clinical trials

Recent Litigation for tenofovir disoproxil fumarate

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District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Merck & Co., Inc.2016-07-06
Gilead Sciences v. Sigmapharm Labs2014-05-05
Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc.2010-03-05

See all tenofovir disoproxil fumarate litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2014-06-04

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Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGTABLET; ORAL
  Start Trial  Start Trial300MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Paragraph IV (Patent) Challenges for TENOFOVIR DISOPROXIL FUMARATE
Tradename Dosage Ingredient NDA Submissiondate
VIREAD TABLET;ORAL tenofovir disoproxil fumarate 021356 2012-05-17
VIREAD TABLET;ORAL tenofovir disoproxil fumarate 021356 2010-01-26

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
Qilu Pharm Co Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 209498-003 Mar 2, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 091612-004 Jan 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Qilu Pharm Co Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 209498-002 Mar 2, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-002 Jan 18, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-003 Jan 18, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 021356-001 Oct 26, 2001   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-002 Jan 18, 2012   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate POWDER;ORAL 022577-001 Jan 18, 2012   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-003 Jan 18, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.