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Last Updated: November 2, 2024

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 one supplier. There are nine 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
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.

Pharmacology for NDA: 214410
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:RXDosage:FOR SUSPENSION;ORALStrength2MG/ML
Approval Date:Nov 23, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 27, 2036Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 27, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
Patent:⤷  Sign UpPatent Expiration:Apr 27, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INFLUENZA

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