Details for New Drug Application (NDA): 208351

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NDA 208351 describes ODEFSEY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ODEFSEY profile page.

The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; 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; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.

Summary for 208351

Tradename:	ODEFSEY
Applicant:	Gilead Sciences Inc
Ingredient:	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Patents:	2

Pharmacology for NDA: 208351

Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 208351

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351	NDA	Gilead Sciences, Inc.	61958-2101	61958-2101-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;EQ 25MG BASE;EQ 25MG BASE
Approval Date:	Mar 1, 2016	TE:	AB	RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Feb 15, 2033	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Start Trial	Patent Expiration:	Feb 15, 2033	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 208351

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	⤷ Start Trial	⤷ Start Trial
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	⤷ Start Trial	⤷ Start Trial
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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