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Last Updated: November 19, 2019

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Raltegravir potassium - Generic Drug Details

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What are the generic drug sources for raltegravir potassium and what is the scope of patent protection?

Raltegravir potassium is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Raltegravir potassium has one hundred and fourteen patent family members in forty-four countries.

There are five drug master file entries for raltegravir potassium. Six suppliers are listed for this compound.

Summary for raltegravir potassium
Recent Clinical Trials for raltegravir potassium

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

SponsorPhase
St. James's Hospital, IrelandPhase 4
Merck Sharp & Dohme Corp.Phase 1/Phase 2
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 1/Phase 2

See all raltegravir potassium clinical trials

Pharmacology for raltegravir potassium
Medical Subject Heading (MeSH) Categories for raltegravir potassium
Synonyms for raltegravir potassium
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
BCP01757
BCPP000092
C20H20FN6O5.K
CHEMBL518520
CS-3263
CTK8E9230
D07133
FT-0649661
HY-10353A
I06-2266
IFUKBHBISRAZTF-UHFFFAOYSA-M
Isentress
Isentress (TN)
J10313
KS-000000A6
MK 0518
MK-518
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)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 (JAN/USAN)
Raltegravir potassium [USAN:JAN]
Raltegravir Potassium Salt
Raltegravir(MK-0518)
RaltegravirPotassiumSalt
RT-015376
SC-99419
SCHEMBL15939218
TRA0035437
UNII-43Y000U234
X4991
Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM
Tradename Dosage Ingredient NDA Submissiondate
ISENTRESS HD TABLET;ORAL raltegravir potassium 022145 2011-10-12
ISENTRESS TABLET;ORAL raltegravir potassium 022145 2011-10-12

US Patents and Regulatory Information for raltegravir potassium

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 raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No   Start Trial   Start Trial   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
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes   Start Trial   Start Trial Y   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 raltegravir potassium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 PA2008 007, C1441735 Lithuania   Start Trial PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 PA2008007 Lithuania   Start Trial PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
1441735 C 2008 008 Romania   Start Trial PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735 122008000016 Germany   Start 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 91428 Luxembourg   Start Trial 91428, EXPIRES: 20230102
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Dow
Harvard Business School
AstraZeneca
Merck

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