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Last Updated: February 19, 2020

DrugPatentWatch Database Preview

TENOFOVIR DISOPROXIL FUMARATE Drug Profile


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Which patents cover Tenofovir Disoproxil Fumarate, and when can generic versions of Tenofovir Disoproxil Fumarate launch?

Tenofovir Disoproxil Fumarate is a drug marketed by Aurobindo Pharma Ltd, Casi Pharms Inc, Chartwell, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Qilu, Strides Pharma, and Teva Pharms Usa. and is included in ten NDAs.

The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Tenofovir Disoproxil Fumarate

A generic version of TENOFOVIR DISOPROXIL FUMARATE was approved as tenofovir disoproxil fumarate by TEVA PHARMS USA on March 18th, 2015.

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Drug patent expirations by year for TENOFOVIR DISOPROXIL FUMARATE
Drug Prices for TENOFOVIR DISOPROXIL FUMARATE

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Recent Clinical Trials for TENOFOVIR DISOPROXIL FUMARATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Beijing Ditan HospitalPhase 4
Dr. Josep MallolasPhase 4
David Garcia CincaPhase 4

See all TENOFOVIR DISOPROXIL FUMARATE clinical trials

Recent Litigation for TENOFOVIR DISOPROXIL FUMARATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
United States v. Gilead Sciences, Inc.2019-11-06
Gilead Sciences, Inc. v. Merck & Co., Inc.2016-07-06
Gilead Sciences v. Sigmapharm Labs2014-05-05

See all TENOFOVIR DISOPROXIL FUMARATE litigation

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

See all TENOFOVIR DISOPROXIL FUMARATE litigation

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
Aurobindo Pharma Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-001 Jan 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 091612-002 Jan 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 078800-001 Jan 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-004 Jan 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 206569-003 Nov 27, 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
Hetero Labs Ltd Iii TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090636-001 Jan 26, 2018 AB RX No 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

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