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Last Updated: January 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210854

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NDA 210854 describes XOFLUZA, which is a drug marketed by Genentech Inc and is included in one NDA. It is available from two suppliers. There are four 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 210854
Tradename:XOFLUZA
Applicant:Genentech Inc
Ingredient:baloxavir marboxil
Patents:4
Generic Entry Opportunity Date for 210854
Generic Entry Date for 210854*:
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: 210854
Suppliers and Packaging for NDA: 210854
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XOFLUZA baloxavir marboxil TABLET;ORAL 210854 NDA A-S Medication Solutions 50090-4102 50090-4102-0 1 BLISTER PACK in 1 CARTON (50090-4102-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK
XOFLUZA baloxavir marboxil TABLET;ORAL 210854 NDA A-S Medication Solutions 50090-4104 50090-4104-0 1 BLISTER PACK in 1 CARTON (50090-4104-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 24, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 24, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 16, 2022
Regulatory Exclusivity Use:TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 48 HOURS AND ARE AT HIGH RISK OF DEVELOPING INFLUENZA-RELATED COMPLICATIONS
Patent:  Start TrialPatent Expiration:Apr 27, 2036Product Flag?Substance Flag?YDelist Request?

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