Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic drug sources for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has five hundred and eighty-five patent family members in fifty-four countries.

There are five drug master file entries for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. Four suppliers are listed for this compound.

Summary for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

International Patents:	585
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Suppliers / Packagers:	4
Clinical Trials:	25
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
DailyMed Link:	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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Sponsor	Phase
Gilead Sciences	Phase 1/Phase 2
University of California, Los Angeles	Phase 1/Phase 2
Brigham and Women's Hospital	N/A

See all cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate clinical trials

Recent Litigation for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Japan Tobacco Inc. v. Mylan Pharmaceuticals Inc.	2019-01-24
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.	2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.	2018-06-27

See all cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate litigation

PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc.	2014-06-04

See all cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate litigation

Pharmacology for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Cytochrome P450 3A Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Cytochrome P450 2C9 Inducers 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 Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
STRIBILD	TABLET;ORAL	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	203100	2018-10-04

US Patents and Regulatory Information for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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Glossary

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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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	Start Trial	Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	Start Trial	Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	Start Trial	Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	Start Trial	Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	Start Trial	Start Trial
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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Country	Patent Number	Estimated Expiration
European Patent Office	2229945	Start Trial
Lithuania	PA2016039	Start Trial
Peru	20120361	Start Trial
Norway	2005015	Start Trial
Canada	2720856	Start Trial
Croatia	P20050619	Start Trial
Canada	2566922	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	15C0078	France	Start Trial	PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
0513200	7/2004	Austria	Start Trial	PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
2049506	C20150046 00250	Estonia	Start Trial	PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013
2487162	122016000103	Germany	Start Trial	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
2487162	1790003-6	Sweden	Start Trial	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; REG. NO/DATE: EU/1/14/967 20141121
2049506	300780	Netherlands	Start Trial	PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
1564210	CR 2013 00058	Denmark	Start Trial	PRODUCT NAME: ELVITEGRAVIR ELLER ET HYDRAT, ET SOLVAT, EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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