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Last Updated: December 9, 2019

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Cobicistat - Generic Drug Details

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What are the generic drug sources for cobicistat and what is the scope of 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 twenty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat has two hundred and sixty-two patent family members in thirty-nine countries.

There are five drug master file entries for cobicistat. One supplier is listed for this compound.

Recent Clinical Trials for cobicistat

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

SponsorPhase
Janssen Pharmaceutica N.V., BelgiumPhase 1
Southampton Healthcare, Inc.Phase 4
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludPhase 4

See all cobicistat clinical trials

Recent Litigation for cobicistat

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc.2017-02-22
Gilead Sciences Inc. v. Mylan Pharmaceuticals Inc.2016-03-25
Gilead Sciences, Inc. v. Lee2013-12-11

See all cobicistat litigation

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
AC-28961
AKOS025404908
AOB87771
AS-17061
BCP06630
BDBM50447471
CHEBI:72291
CHEMBL2095208
Cobicistat (GS-9350)
Cobicistat (JAN/USAN/INN)
Cobicistat [USAN:INN]
Cobicistat,GS-9350
Cobicistat; GS-9350
cobicistatum
CS-0742
D09881
DB09065
DTXSID00143269
EX-A2578
GS 9350
GS-9350
GTPL7535
HY-10493
KB-76152
KS-00000T52
LW2E03M5PG
MolPort-035-395-741
QCR-199
s2900
SB16687
SCHEMBL2736227
SW219553-1
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
Paragraph IV (Patent) Challenges for COBICISTAT
Tradename Dosage Ingredient NDA Submissiondate
TYBOST TABLET;ORAL cobicistat 203094 2016-11-14

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
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 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 cobicistat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 2016/062 Ireland   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTRATION NO/DATE: EU/1/15/1025 20160713
2049506 CR 2015 00060 Denmark   Start Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2487162 284 1-2017 Slovakia   Start Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/DARUNAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/967 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Harvard Business School
McKesson
Moodys
Boehringer Ingelheim

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