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GENVOYA Drug Profile

Which patents cover Genvoya, and when can generic versions of Genvoya launch?

Genvoya is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has six hundred and fifty patent family members in sixty countries.

The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.

Summary for GENVOYA

International Patents:	650
US Patents:	13
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Clinical Trials:	20
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GENVOYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GENVOYA
DailyMed Link:	GENVOYA at DailyMed

Drug patent expirations by year for GENVOYA

Generic Entry Opportunity Date for GENVOYA

Generic Entry Date for GENVOYA^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 207561 Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GENVOYA

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

Sponsor	Phase
Henry M. Jackson Foundation for the Advancement of Military Medicine	N/A
CIHR Canadian HIV Trials Network	Phase 2
St. Michael's Hospital, Toronto	Phase 2

See all GENVOYA clinical trials

Recent Litigation for GENVOYA

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 GENVOYA litigation

Pharmacology for GENVOYA

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

US Patents and Regulatory Information for GENVOYA

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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	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		RX	Yes	Yes	Start Trial	Start Trial			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 GENVOYA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	Start Trial	Start Trial
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for GENVOYA

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Country	Patent Number	Estimated Expiration
Bulgaria	107572	Start Trial
Japan	3479068	Start Trial
African Intellectual Property Organization (OAPI)	12393	Start Trial
Finland	20030933	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for GENVOYA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	300803	Netherlands	Start Trial	PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
1301519	16C0013	France	Start Trial	PRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1564210	122013000088	Germany	Start Trial	PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524
0513200	SZ 7/2004	Austria	Start Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description