Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 20, 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-one 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

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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

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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
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   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   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial   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 CA 2017 00003 Denmark   Start Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG ATAZANAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER ATAZANAVIRSULFAT; REG. NO/DATE: EU/1/15/1025/001-002 20150715
2487163 C20170001 00217 Estonia   Start Trial PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2049506 300780 Netherlands   Start Trial PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2487166 59/2016 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123
2049506 262 5024-2015 Slovakia   Start Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZA-; REGISTRATION NO/DATE: EU/1/13/830 20130527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKinsey
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Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.