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Last Updated: April 5, 2020

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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-three 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.

US ANDA Litigation and Generic Entry Outlook for Isentress

Isentress was eligible for patent challenges on October 12, 2011.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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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
Canadian Institutes of Health Research (CIHR)Phase 2
CIHR Canadian HIV Trials NetworkPhase 2
St. Michael's Hospital, TorontoPhase 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
A25486
A4073
A828788
AB0028054
AB01274746-01
AB01566833_01
AB1004864
ABP000913
AC-2062
AC-5261
AK326327
AK326594
AKOS015896594
AKOS015902444
AKOS025149884
AKOS032960305
AOB87131
API0000801
AS-16992
AS-19171
BCP01394
BCP01757
BCPP000092
BCPP000093
BDBM25351
BRD-K05658747-237-01-1
C20H20FN6O5.K
C20H21FN6O5
CAS-518048-05-0
CHEMBL254316
CHEMBL518520
CS-2396
CS-3263
CTK8E9230
CZFFBEXEKNGXKS-UHFFFAOYSA-N
D06676
D07133
DB06817
DSSTox_CID_28586
DSSTox_GSID_48660
DSSTox_RID_82857
DTXSID2048660
DTXSID501007339
EC-000.2353
EX-A2147
FT-0649660
FT-0649661
HMS3655B09
HSDB 8124
HY-10353
HY-10353A
IFUKBHBISRAZTF-UHFFFAOYSA-M
Isentress (TN)
Isentress(TM)
J10313
KS-000000A6
KS-00000XJN
MCULE-4916399246
MK 0518
MK 0518 potassium salt
MK-0518
MK-0518 POTASSIUM
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
MK0518 POTASSIUM
MLS006011985
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]-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-[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)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxopyrimidin-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)methyl]imino}(hydroxy)methyl]-1-methyl-2-{2-[(5-methyl-1,3,4-oxadiazole-2-carbonyl)amino]propan-2-yl}-6-oxo-1,6-dihydropyrimidin-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
Q27258678
Q421552
Raltegravir
Raltegravir - MK-0518
Raltegravir ( K salt) API
Raltegravir (MK-0518)
Raltegravir (potassium salt)
Raltegravir (USAN/INN)
Raltegravir [USAN:INN]
Raltegravir monopotassium salt
Raltegravir potassium
Raltegravir potassium (JAN/USAN)
Raltegravir potassium [USAN:JAN]
Raltegravir Potassium Salt
Raltegravir-(MK-0518)
raltegravir-potassium
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
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
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 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 300340 Netherlands   Start Trial PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102
1441735 C01441735/01 Switzerland   Start Trial FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
1441735 30/2008 Austria   Start Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436/001- EU/1/07/436/002 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 C300340 Netherlands   Start Trial PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 DO 67; 3-2008 Slovakia   Start Trial PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Mallinckrodt
Harvard Business School
Express Scripts
Moodys

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 verification 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.