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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

ISENTRESS Drug Profile

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Which patents cover Isentress, and when can generic versions of Isentress launch?

Isentress is a drug marketed by Merck Sharp Dohme and is included in three NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-two patent family members in forty-two countries.

The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

Drug patent expirations by year for ISENTRESS
Drug Prices for ISENTRESS

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Recent Clinical Trials for ISENTRESS

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SponsorPhase
CIHR Canadian HIV Trials NetworkPhase 2
St. Michael's Hospital, TorontoPhase 2
Canadian Institutes of Health Research (CIHR)Phase 2

See all ISENTRESS clinical trials

Synonyms for ISENTRESS
[(5-methyl-1,3,4-oxadiazol-2-yl)formamido]propan-2-
038R721
048R050
22VKV8053U
4-Pyrimidinecarboxamide, N-((4-fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo- (9CI)
4-Pyrimidinecarboxamide, N-((4-fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-, monopotassium salt
43Y000U234
518048-05-0
871038-72-1
871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133
925701-81-1
A25486
A4073
A828788
AB0028054
AB01274746-01
AB01566833_01
AB1004864
ABP000913
AC-2062
AC-5261
AK326327
AK326594
AKOS015896594
AKOS015902444
AKOS025149884
AKOS032960305
AN-3529
AN-406
AOB87131
API0000801
AS-16992
AS-19171
BC228658
BCP01394
BCP01757
BCPP000092
BCPP000093
BDBM25351
BRD-K05658747-237-01-1
C20H20FN6O5.K
C20H21FN6O5
CAS-518048-05-0
CHEMBL254316
CHEMBL518520
CJ-14473
CS-2396
CS-3263
CTK8E9230
CZFFBEXEKNGXKS-UHFFFAOYSA-N
D06676
D07133
DB06817
DSSTox_CID_28586
DSSTox_GSID_48660
DSSTox_RID_82857
DTXSID2048660
EX-A2147
FT-0649660
FT-0649661
HMS3655B09
HSDB 8124
HY-10353
HY-10353A
I06-2266
I14-1973
IFUKBHBISRAZTF-UHFFFAOYSA-M
Isentress (TN)
Isentress(TM)
J10313
KS-000000A6
KS-00000XJN
MCULE-4916399246
MK 0518
MK-0518
MK-0518;MK 0518;MK0518
MK-0518;N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide Potassium Salt
MK-518
MK0518
MLS006011985
MolPort-003-987-726
MolPort-006-395-835
N-((4-Fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-4-pyrimidinecarboxamide
N-((4-Fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-4-pyrimidinecarboxamide monopotassium salt
N-(2-(4-((4-fluorobenzyl)carbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)-5-methyl-1,3,4-oxadiazole-2-carboxamide
N-(2-(4-(4-fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1, 6-dihydropyrimidin-2-yl)propan-2-yl) -5-methyl-1,3,4-oxadiazole-2- carboxamide
N-(2-(4-(4-Fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)-5-methyl-1,3,4-oxadiazole-2-carboxamide
N-(4-Fluorobenzyl)-5-Hydroxy-1-Methyl-2-(1-Methyl-1-{[(5-Methyl-1,3,4-Oxadiazol-2-Yl)carbonyl]amino}ethyl)-6-Oxo-1,6-Dihydropyrimidine-4-Carboxamide
N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide Potassium Salt
N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-2-{2-
N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-2-{2-[(5-methyl-1,3,4-oxadiazol-2-yl)formamido]propan-2-yl}-6-oxo-1,6-dihydropyrimidine-4-carboxamide
N-[1-[(4Z)-4-[[(4-fluorophenyl)methylamino]-hydroxy-methylene]-1-methyl-5,6-dioxo-pyrimidin-2-yl]-1-methyl-ethyl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
N-[1-[4-[(4-fluorophenyl)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxo-pyrimidin-2-yl]-1-methyl-ethyl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
N-[2-(4-{[(4-fluorophenyl)methyl]carbamoyl}-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
N-[2-[4-[[(4-fluorophenyl)methylamino]-hydroxymethylidene]-1-methyl-5,6-dioxo-2-pyrimidinyl]propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
N-[2-[4-[[(4-fluorophenyl)methylamino]-oxidanyl-methylidene]-1-methyl-5,6-bis(oxidanylidene)pyrimidin-2-yl]propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
NCGC00184997-01
NCGC00274066-01
NCGC00274066-05
PB13312
Potassium 4-((4-fluorobenzyl)carbamoyl)-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-1,6-dihydropyrimidin-5-olate
potassium 4-((4-fluorobenzyl)carbamoyl)-1-methyl-2-(2-(5-methyl-1,3,4-oxadiazole-2-carboxamido)propan-2-yl)-6-oxo-1,6-dihydropyrimidin-5-olate
potassium 4-[(4-fluorophenyl)methylcarbamoyl]-1-methyl-2-[1-methyl-1-[(5-methyl-1,3,4-oxadiazole-2-carbonyl)amino]ethyl]-6-oxo-pyrimidin-5-olate
potassium;4-[(4-fluorophenyl)methylcarbamoyl]-1-methyl-2-[2-[(5-methyl-1,3,4-oxadiazole-2-carbonyl)amino]propan-2-yl]-6-oxopyrimidin-5-olate
PubChem22484
Q-201657
Q-4458
Raltegravir
Raltegravir - MK-0518
Raltegravir ( K salt) API
Raltegravir (MK-0518)
Raltegravir (potassium salt)
Raltegravir (USAN/INN)
Raltegravir [USAN:INN]
Raltegravir potassium
Raltegravir potassium (JAN/USAN)
Raltegravir potassium [USAN:JAN]
Raltegravir Potassium Salt
Raltegravir; MK-0518
Raltegravir(MK-0518)
Raltegravir(MK-0518)/
RaltegravirPotassiumSalt
RGV
RLT
RT-015376
s2005
SB20935
SC-69059
SC-99419
SCHEMBL15939218
SCHEMBL2112870
SCHEMBL51817
SCHEMBL996804
SMR003601806
SW220138-1
TL8006542
Tox21_113019
Tox21_113019_1
TRA0035437
UNII-22VKV8053U
UNII-43Y000U234
X4991
yl}-6-oxo-1,6-dihydropyrimidine-4-carboxamide
Z1551429745
ZINC114994525
ZINC13831130
Paragraph IV (Patent) Challenges for ISENTRESS
Tradename Dosage Ingredient NDA Submissiondate
ISENTRESS TABLET;ORAL raltegravir potassium 022145 2011-10-12
ISENTRESS HD TABLET;ORAL raltegravir potassium 022145 2011-10-12

US Patents and Regulatory Information for ISENTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes   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

Supplementary Protection Certificates for ISENTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 SPC/GB08/020 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
1441735 08C0026 France   Start Trial PRODUCT NAME: RALTEGRAVIR OU L(UN DE SES SELS PHARMACEUTIQUEMENT ACCCEPTABLES EN PARTICULIER UN SEL DE POTASSIUM; REGISTRATION NO/DATE IN FRANCE: EU/1/07/436/001 DU 20071220; REGISTRATION NO/DATE AT EEC: EU/1/07/436/001 DU 20071220
1441735 PA2008007,C1441735 Lithuania   Start Trial PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
1441735 SPC010/2008 Ireland   Start Trial SPC010/2008: 20091119, EXPIRES: 20221219
1441735 91428 Luxembourg   Start Trial 91428, EXPIRES: 20230102
1441735 C20080001 00016 Estonia   Start Trial PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Baxter
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