Details for New Drug Application (NDA): 208215

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NDA 208215 describes DESCOVY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DESCOVY profile page.

The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.

Summary for 208215

Tradename:	DESCOVY
Applicant:	Gilead Sciences Inc
Ingredient:	emtricitabine; tenofovir alafenamide fumarate
Patents:	3

Pharmacology for NDA: 208215

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 208215

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002	61958-2002-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1)
DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002	61958-2002-2	30 TABLET in 1 BLISTER PACK (61958-2002-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;EQ 25MG BASE
Approval Date:	Apr 4, 2016	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 20, 2028
Regulatory Exclusivity Use:	LABELING CHANGES TO INCLUDE THE RESULTS OF STUDY GS-US-216-0128 IN CERTAIN PEDIATRIC PATIENTS
Patent:	7,390,791*PED	Patent Expiration:	Jul 7, 2025	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,754,065*PED	Patent Expiration:	Feb 15, 2033	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 208215

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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	5,814,639*PED	⤷ Get Started Free
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	6,703,396*PED	⤷ Get Started Free
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016	7,803,788	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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