COBICISTAT - Generic Drug Details

What are the generic drug sources for cobicistat and what is the scope of patent protection?

Cobicistat is the generic ingredient in six branded drugs marketed by Mylan Labs Ltd, Gilead Sciences Inc, and Janssen Prods, and is included in six NDAs. There are twenty-four 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 ninety-five patent family members in forty countries.

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

Summary for COBICISTAT

International Patents:	295
US Patents:	24
Tradenames:	6
Applicants:	3
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	128
Patent Applications:	1,310
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
Maastricht University Medical Center	Phase 4
Spaulding Clinical Research LLC	Phase 1
Food and Drug Administration (FDA)	Phase 1

See all COBICISTAT clinical trials

Pharmacology for COBICISTAT

Drug Class	Cytochrome P450 3A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein 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	Strength	NDA	ANDAs Submitted	Submissiondate
TYBOST	Tablets	cobicistat	150 mg	203094	1	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	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014	AB	RX	Yes	Yes					Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		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
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes			Y
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
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes					Y

EU/EMA Drug Approvals for COBICISTAT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Tybost	cobicistat	EMEA/H/C/002572 Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.	Authorised	no	no	no	2013-09-19

International Patents for COBICISTAT

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1143144	MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS
Singapore	10201705929Q	MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS
Hungary	E025822
Taiwan	200904419	Modulators of pharmacokinetic properties of therapeutics
Cyprus	2015046
Montenegro	02631	Modulatori farmakokinetičkih svojstava lijekova (Modulators of pharmacokinetic properties of therapeutics)
Argentina	075369	COMPRIMIDOS PARA TERAPIA DE COMBINACION PARA EL TRATAMIENTO DE INFECCIONES VIRALES.

Supplementary Protection Certificates for COBICISTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	PA2020508	Lithuania		PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527
2487162	SPC/GB17/009	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/967 20141121
2487166	PA2016038	Lithuania		PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487166	380 3-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1061 20151123
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
2487162	PA2016040	Lithuania		PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119