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Generated: September 19, 2018

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Raltegravir potassium - Generic Drug Details

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What are the generic sources for raltegravir potassium and what is the scope of raltegravir potassium freedom to operate?

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.

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

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
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 (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 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, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Supplementary Protection Certificates for raltegravir potassium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
9 Finland ➤ Sign Up
428 Luxembourg ➤ Sign Up 91428, EXPIRES: 20230102
2008000016 Germany ➤ Sign Up PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
/2008 Austria ➤ Sign Up 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
2008 007, C1441735 Lithuania ➤ Sign Up PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
2008007,C1441735 Lithuania ➤ Sign Up PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
C/GB08/020 United Kingdom ➤ Sign Up 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.
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Julphar
Cantor Fitzgerald
UBS
McKesson
Fuji
Federal Trade Commission
Dow

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