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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Moodys
Boehringer Ingelheim
Healthtrust
Teva
Mallinckrodt
Queensland Health
Merck
Federal Trade Commission

Generated: December 17, 2018

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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 eighty-nine patent family members in forty-one countries.

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

Drug patent expirations by year for ISENTRESS
Medical Subject Heading (MeSH) Categories for ISENTRESS
Synonyms for ISENTRESS
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
871038-72-1
925701-81-1
AB01274746-01
AC-2062
AK326594
AKOS015896594
AN-406
API0000801
AS-19171
BCPP000092
C20H20FN6O5.K
CHEMBL518520
CS-3263
CTK8E9230
D07133
FT-0649661
HE070008
HE399405
HY-10353A
I06-2266
IFUKBHBISRAZTF-UHFFFAOYSA-M
Isentress (TN)
J10313
KS-000000A6
MFCD12031642
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 monopotassium salt
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-[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
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)METHYL]CARBAMOYL}-1-METHYL-2-{2-[(5-METHYL-1,3,4-OXADIAZOL-2-YL)FORMAMIDO]PROPAN-2-YL}-6-OXOPYRIMIDIN-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
Raltegravir ( K salt) API
Raltegravir (potassium salt)
Raltegravir potassium
Raltegravir potassium (JAN/USAN)
Raltegravir potassium [USAN:JAN]
Raltegravir Potassium Salt
Raltegravir(MK-0518)
Raltegravirpotassium
RaltegravirPotassiumSalt
RT-015376
SC-99419
SCHEMBL15939218
TRA0035437
UNII-43Y000U234
X4991

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Paragraph IV (Patent) Challenges for ISENTRESS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 400 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for ISENTRESS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0026 France ➤ Try a Free 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
9 Finland ➤ Try a Free Trial
2008007,C1441735 Lithuania ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
2008000016 Germany ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735/01 Switzerland ➤ Try a Free Trial FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
221021 Netherlands ➤ Try a Free Trial 20221021, EXPIRES: 20221219
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Moodys
Boehringer Ingelheim
Healthtrust
Teva
Mallinckrodt
Queensland Health
Merck
Federal Trade Commission

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