Details for New Drug Application (NDA): 214410

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

The generic ingredient in XOFLUZA is baloxavir marboxil. One supplier is 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:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 214410

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.

Pharmacology for NDA: 214410

Mechanism of Action

Chelating Activity Polymerase Acidic Endonuclease Inhibitors

Suppliers and Packaging for NDA: 214410

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410	NDA	Genentech, Inc.	50242-583	50242-583-01	1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	2MG/ML
Approval Date:	Nov 23, 2020	TE:		RLD:	Yes
Patent:		Patent Expiration:	Apr 27, 2036	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Apr 27, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
Patent:		Patent Expiration:	Apr 27, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR TREATING INFLUENZA

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