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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.

Summary for cobicistat

International Patents:	261
US Patents:	28
Tradenames:	5
Applicants:	2
NDAs:	5
Drug Master File Entries:	5
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	96
Patent Applications:	66
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat
DailyMed Link:	cobicistat at DailyMed

Recent Clinical Trials for cobicistat

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

Sponsor	Phase
Janssen Pharmaceutica N.V., Belgium	Phase 1
Southampton Healthcare, Inc.	Phase 4
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Phase 4

See all cobicistat clinical trials

Recent Litigation for cobicistat

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc.	2017-02-22
Gilead Sciences Inc. v. Mylan Pharmaceuticals Inc.	2016-03-25
Gilead Sciences, Inc. v. Lee	2013-12-11

See all cobicistat litigation

Pharmacology for cobicistat

Drug Class	Cytochrome P450 3A Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Breast Cancer Resistance Protein Inhibitors

Medical Subject Heading (MeSH) Categories for cobicistat

Anti-HIV Agents

Cytochrome P-450 CYP3A Inhibitors

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

International Patents for cobicistat

Country	Patent Number	Estimated Expiration
Argentina	106924
Japan	2015078241
European Patent Office	2487163
Japan	2010532755

Supplementary Protection Certificates for cobicistat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	60/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
2487163	2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487162	2016/063	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119
2487166	1790001-0	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123