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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 214410


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NDA 214410 describes XOFLUZA, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the XOFLUZA profile page.

The generic ingredient in XOFLUZA is baloxavir marboxil. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.
Summary for 214410
Tradename:XOFLUZA
Applicant:Genentech Inc
Ingredient:baloxavir marboxil
Patents:6
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 214410
Generic Entry Date for 214410*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength2MG/ML
Approval Date:Nov 23, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 24, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Free Forever TrialPatent Expiration:Apr 27, 2036Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Apr 27, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA

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