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Last Updated: December 12, 2019

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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
Applicant:Gilead Sciences Inc
Ingredient:tenofovir alafenamide fumarate
Generic Entry Opportunity Date for 208464
Generic Entry Date for 208464*:
Constraining patent/regulatory exclusivity:

*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
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:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 10, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 11, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:May 7, 2022Product Flag?YSubstance Flag?YDelist Request?

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