EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

What are the generic sources for emtricitabine; tenofovir alafenamide fumarate and what is the scope of patent protection?

Emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir alafenamide fumarate has one hundred and thirty-two patent family members in fifty countries.

One supplier is listed for this compound.

Summary for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

International Patents:	132
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	41
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
DailyMed Link:	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

Sponsor	Phase
Chiang Mai University, Thailand	Phase 3
ANRS, Emerging Infectious Diseases	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3

See all EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Pharmacology for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	120 mg/15 mg	208215	1	2022-10-31
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	200 mg/25 mg	208215	6	2019-11-05

US Patents and Regulatory Information for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No

Expired US Patents for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016

International Patents for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1199026	替諾福韋艾拉酚胺 半反丁烯二酸鹽 (TENOFOVIR ALAFENAMIDE HEMIFUMARATE (TENOFOVIRALAFENAMIDE))
Canada	2416757	PROMEDICAMENTS A BASE D'ANALOGUES NUCLEOTIDIQUES DE PHOSPHONATE ET LEURS METHODES DE SELECTION ET D'ELABORATION (PRODRUGS OF PHOSPHONATE NUCLEOTIDE ANALOGUES AND METHODS FOR SELECTING AND MAKING SAME)
Lithuania	2744810
South Korea	20030022295

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	16C0013	France		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
1663240	2016/058	Ireland		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457)
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
3808743	301190	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128