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QuintilesIMS
Dow
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Healthtrust
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Johnson and Johnson
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Daiichi Sankyo
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Generated: September 21, 2018

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Cobicistat - Generic Drug Details

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

Cobicistat is the generic ingredient in five branded drugs marketed by Gilead Sciences Inc and Janssen Prods, and is included in five NDAs. There are thirty-three 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 cobicistat. One supplier is listed for this compound.

Medical Subject Heading (MeSH) Categories for cobicistat
Synonyms for cobicistat
1,3-thiazol-5-ylmethyl [(2R,5R)-5-{[(2S)-2-({[(2-isopropyl-1,3-thiazol-4-yl)methyl](methyl)carbamoyl}amino)-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate
1,3-thiazol-5-ylmethyl N-[(2R,5R)-5-[[(2S)-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]-4-morpholin-4-ylbutanoyl]amino]-1,6-diphenylhexan-2-yl]carbamate
1004316-88-4
2,7,10,12-Tetraazatridecanoic acid, 12-methyl-13-(2-(1-methylethyl)-4-thiazolyl)-9-(2-(4-morpholinyl)ethyl)-8,11-dioxo-3,6-bis(phenylmethyl)-, 5-thiazolylmethyl ester, (3R,6R,9S)-
AB0093115
AB01566899_01
AK174896
AKOS025404908
AOB87771
AS-17061
BDBM50447471
CHEBI:72291
CHEMBL2095208
Cobicistat (GS-9350)
Cobicistat (JAN/USAN/INN)
Cobicistat [USAN:INN]
Cobicistat,GS-9350
Cobicistat/darunavir
cobicistatum
CS-0742
D02VJP
D09881
D0V4ZN
DB09065
DTXSID00143269
GS 9350
GS-9350
GTPL7535
HY-10493
KB-76152
KS-00000T52
LW2E03M5PG
MFCD18251449
MolPort-035-395-741
QCR-199
s2900
SCHEMBL2736227
Thiazol-5-ylmethyl ((1R,4R)-1-benzyl-4-({(2S)-2-((methyl{(2-(1-methylethyl)thiazol-4-yl)methyl}carbamoyl)amino)-4-(morpholin-4-yl)butanoyl}amino)-5-phenylpentyl)carbamate
thiazol-5-ylmethyl ((2R,5R)-5-((S)-2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-4-morpholinobutanamido)-1,6-diphenylhexan-2-yl)carbamate
thiazol-5-ylmethyl (2R,5R)-5-((S)-2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-4-morpholinobutanamido)-1,6-diphenylhexan-2-ylcarbamate
thiazol-5-ylmethyl N-[(1R,4R)-1-benzyl-4-[[(2S)-2-[[(2-isopropylthiazol-4-yl)methyl-methyl-carbamoyl]amino]-4-morpholino-butanoyl]amino]-5-phenyl-pentyl]carbamate
Tybost
Tybost (TN)
UNII-LW2E03M5PG
ZCIGNRJZKPOIKD-CQXVEOKZSA-N
ZINC85537014

US Patents and Regulatory Information for cobicistat

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y 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 cobicistat

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000103 Germany ➤ Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
C0078 France ➤ Sign Up PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
0170001 00217 Estonia ➤ Sign Up PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2015040,C2049506 Lithuania ➤ Sign Up PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2016038 Lithuania ➤ Sign Up PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
90002-8 Sweden ➤ Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Dow
Boehringer Ingelheim
Healthtrust
Teva
Johnson and Johnson
Mallinckrodt
Daiichi Sankyo
Merck

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