Details for New Drug Application (NDA): 208464

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NDA 208464 describes VEMLIDY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the VEMLIDY profile page.

The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.

Summary for 208464

Tradename:	VEMLIDY
Applicant:	Gilead Sciences Inc
Ingredient:	tenofovir alafenamide fumarate
Patents:	4

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 208464

Generic Entry Date for 208464^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing 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.

Pharmacology for NDA: 208464

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 208464

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464	NDA	Gilead Sciences, Inc.	61958-2301	61958-2301-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Nov 10, 2016	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Feb 4, 2023
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4018 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALAFENAMIDE
Regulatory Exclusivity Expiration:	Aug 22, 2023
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4035 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALFAENAMIDE
Regulatory Exclusivity Expiration:	Oct 17, 2025
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 208464

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VEMLIDY	tenofovir alafenamide fumarate	TABLET;ORAL	208464-001	Nov 10, 2016	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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