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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 cobicistat freedom to operate?

Cobicistat is the generic ingredient in four branded drugs marketed by Gilead Sciences Inc and Janssen Prods, and is included in four NDAs. There are twenty-six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for cobicistat

International Patents:	161
US Patents:	26
Tradenames:	4
Applicants:	2
NDAs:	4
Drug Master File Entries:	5
Suppliers / Packagers:	1
Bulk Api Vendors:	36
Clinical Trials:	76
Patent Applications:	57
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
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
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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		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
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes			Y

Non-Orange Book US Patents for cobicistat

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,088,770	Modulators of pharmacokinetic properties of therapeutics
8,383,655	Modulators of pharmacokinetic properties of therapeutics
8,486,942	Modulators of pharmacokinetic properties of therapeutics
7,939,553	Modulators of pharmacokinetic properties of therapeutics

International Patents for cobicistat

Country	Document Number	Estimated Expiration
Japan	6147388
Taiwan	200811167
Lithuania	C2049506
Japan	2015078241

Supplementary Protection Certificates for cobicistat

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016038	Lithuania		PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
16/063	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
2017 00003	Denmark		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
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