Details for Patent: 8,754,065

Which drugs does patent 8,754,065 protect, and when does it expire?

Patent 8,754,065 protects BIKTARVY, SYMTUZA, DESCOVY, GENVOYA, ODEFSEY, and VEMLIDY, and is included in six NDAs.

Protection for BIKTARVY has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-seven patent family members in forty-one countries.

Summary for Patent: 8,754,065

Title:	Tenofovir alafenamide hemifumarate
Abstract:	A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]- methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies).
Inventor(s):	Liu; Dazhan (Alberta, CA), Shi; Bing (Foster City, CA), Wang; Fang (Foster City, CA), Yu; Richard Hung Chiu (San Francisco, CA)
Assignee:	Gilead Sciences, Inc. (CA)
Application Number:	13/586,358
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,754,065
Patent Claim Types: see list of patent claims	Compound; Composition; Use; Process; Formulation;

Recent additions to Drugs Protected by US Patent 8,754,065

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET	208464	Nov 10, 2016	RX	Yes		Y	Y			U-1275	TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET	208464	Nov 10, 2016	RX	Yes		Y	Y			U-3880	TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 25 KG
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET	208464	Nov 10, 2016	RX	Yes		Y	Y			U-999	TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS

Drugs Protected by US Patent 8,754,065

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No			Y	Y		TREATMENT OF HIV INFECTION
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No					Y

International Family Members for US Patent 8,754,065

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3639
Argentina	087546
Australia	2012296622
Australia	2014271320
Brazil	112014003420