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Last Updated: April 1, 2020

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VIREAD Drug Profile


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When do Viread patents expire, and when can generic versions of Viread launch?

Viread is a drug marketed by Gilead Sciences Inc and is included in two NDAs.

The generic ingredient in VIREAD 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.

Drug patent expirations by year for VIREAD
Drug Prices for VIREAD

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Recent Clinical Trials for VIREAD

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SponsorPhase
Third Affiliated Hospital, Sun Yat-Sen UniversityN/A
Ohio State UniversityPhase 4
University of North Carolina, Chapel HillPhase 4

See all VIREAD clinical trials

Recent Litigation for VIREAD

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 VIREAD litigation

PTAB Litigation
PetitionerDate
2014-06-04

See all VIREAD litigation

Synonyms for VIREAD
(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
2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, 1,9-bis(1-methylethyl) ester, 5-oxide, (2E)-2-butenedioate (1:1)
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
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
GS 4331-05
GS-1278 Disoproxil Fumarate
GS-4331-05
GS-4331-05-
GS-US-104-0321
GSK-548470
HSDB 7165
HY-13782
KS-1246
LS-173814
MLS004774141
OTT9J7900I
PMPA-PRODRUG
Q-201788
Q27132754
RTR-009415
s1400
SC-24733
SCHEMBL2670560
SCHEMBL40021
SMR003500786
ST2413816
Tenofovir (Disoproxil Fumarate)
Tenofovir DF
Tenofovir Disoproxil Fumarate
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 (TN)
Paragraph IV (Patent) Challenges for VIREAD
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 VIREAD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate POWDER;ORAL 022577-001 Jan 18, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 AB RX Yes 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 021356-004 Jan 18, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate POWDER;ORAL 022577-001 Jan 18, 2012 RX Yes Yes   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
>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 VIREAD

Supplementary Protection Certificates for VIREAD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 19C1025 France   Start Trial PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE LAMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 20181126
2487166 17C1001 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1419152 132012902054377 Italy   Start Trial PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1663240 93382 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
1663240 PA2015038 Lithuania   Start Trial PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
0915894 SPC/GB05/041 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Baxter
Colorcon
McKesson
Johnson and Johnson

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