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Last Updated: October 4, 2024

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 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 210854
Tradename:XOFLUZA
Applicant:Genentech Inc
Ingredient:baloxavir marboxil
Patents:8
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 Genentech, Inc. 50242-860 50242-860-01 1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
XOFLUZA baloxavir marboxil TABLET;ORAL 210854 NDA Genentech, Inc. 50242-860 50242-860-86 1 BLISTER PACK in 1 CARTON (50242-860-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 24, 2018TE: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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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.