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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.

Summary for cobicistat

US Patents:	33
Tradenames:	5
Applicants:	2
NDAs:	5
Drug Master File Entries:	5
Suppliers / Packagers:	1
Bulk Api Vendors:	42
Clinical Trials:	76
Patent Applications:	57
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat
DailyMed Link:	cobicistat at DailyMed

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

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
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes					Y
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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes			Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		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

International Patents for cobicistat

Country	Document Number	Estimated Expiration
Slovenia	2487162
South Korea	20110015581
China	103275033
Ukraine	101193
Lithuania	2487166
South Korea	101784647

Supplementary Protection Certificates for cobicistat

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016000103	Germany		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		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
0170001 00217	Estonia		PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2015040,C2049506	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2016038	Lithuania		PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
90002-8	Sweden		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