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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 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-three 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 eighty-three 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:	283
US Patents:	23
Tradenames:	5
Applicants:	2
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	115
Patent Applications:	1,347
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat
What excipients (inactive ingredients) are in cobicistat?	cobicistat excipients list
DailyMed Link:	cobicistat at DailyMed

Recent Clinical Trials for cobicistat

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

Sponsor	Phase
THOMAS STEHL/ HENRI MONDOR HOSPITAL-Department of Nephrology	Phase 4
LAMBERT ASSOUMOU/ UNITE 1136 INSERM	Phase 4
Sebastien GALLIEN/Henri Mondor University Hospital- Infectiology Department	Phase 4

See all cobicistat clinical trials

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

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	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		RX	Yes	Yes
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

International Patents for cobicistat

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	030123
Japan	2012051933
Chile	2011001885
Cyprus	1118219
Hungary	S2000013
Singapore	10201706215U

Supplementary Protection Certificates for cobicistat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	CR 2015 00060	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2487166	59/2016	Austria		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
2487163	C20170001 00217	Estonia		PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2487162	PA2016040	Lithuania		PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527
2049506	C 2015 045	Romania		PRODUCT NAME: COBICISTAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001-002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20130524