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Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

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What are the generic sources for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate and what is the scope of bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate freedom to operate?

Bictegravir sodium; 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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate has three hundred and seventy-one patent family members in sixty-three countries.

One supplier is listed for this compound.

Summary for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

International Patents:	371
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	3,353
Drug Prices:	see low prices
DailyMed Link:	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate at DailyMed

Pharmacology for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

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

US Patents and Regulatory Information for bictegravir sodium; 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	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes			Y	Y

Non-Orange Book US Patents for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,276,151	Method of synthesis of 1,3-dioxolane nucleosides
5,539,116	Method and compositions for the synthesis of BCH-189 and related compounds
6,931,679	Foldable stand for a hammock
5,700,937	Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds

International Patents for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Country	Document Number	Estimated Expiration
Argentina	103663
Norway	932980
South Africa	200210271
Japan	4496377

Supplementary Protection Certificates for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016009	Lithuania		PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
16/014	Ireland		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061/001-EU/1/15/1061/002 20151119
90012-8	Sweden		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061/001-002 20151123
2004	Austria		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