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Last Updated: July 2, 2020

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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
Tradename:VEMLIDY
Applicant:Gilead Sciences Inc
Ingredient:tenofovir alafenamide fumarate
Patents:4
Generic Entry Opportunity Date for 208464
Generic Entry Date for 208464*:
Constraining patent/regulatory exclusivity:
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
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)
Paragraph IV (Patent) Challenges for 208464
Tradename Dosage Ingredient NDA Submissiondate
VEMLIDY TABLET;ORAL tenofovir alafenamide fumarate 208464 2019-11-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 10, 2016TE: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:Nov 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:May 7, 2022Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.