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Last Updated: October 20, 2021

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Baloxavir marboxil - Generic Drug Details

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What are the generic sources for baloxavir marboxil and what is the scope of patent protection?

Baloxavir marboxil is the generic ingredient in one branded drug marketed by Genentech Inc and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baloxavir marboxil has one hundred and fifty patent family members in thirty-six countries.

Two suppliers are listed for this compound.

Summary for baloxavir marboxil
International Patents:150
US Patents:6
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 25
Clinical Trials: 7
Patent Applications: 23
What excipients (inactive ingredients) are in baloxavir marboxil?baloxavir marboxil excipients list
DailyMed Link:baloxavir marboxil at DailyMed
Recent Clinical Trials for baloxavir marboxil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 2
University of WashingtonPhase 4
ShionogiN/A

See all baloxavir marboxil clinical trials

US Patents and Regulatory Information for baloxavir marboxil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-001 Oct 24, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-001 Oct 24, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Genentech Inc XOFLUZA baloxavir marboxil FOR SUSPENSION;ORAL 214410-001 Nov 23, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Genentech Inc XOFLUZA baloxavir marboxil FOR SUSPENSION;ORAL 214410-001 Nov 23, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Genentech Inc XOFLUZA baloxavir marboxil FOR SUSPENSION;ORAL 214410-001 Nov 23, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-001 Oct 24, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for baloxavir marboxil

Country Patent Number Estimated Expiration
Costa Rica 20170530 ⤷  Free Forever Trial
Japan WO2010147068 ⤷  Free Forever Trial
European Patent Office 2620436 ⤷  Free Forever Trial
Lithuania PA2021505 ⤷  Free Forever Trial
Serbia 61381 ⤷  Free Forever Trial
Spain 2683153 ⤷  Free Forever Trial
Turkey 201810736 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for baloxavir marboxil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2620436 2021C/510 Belgium ⤷  Free Forever Trial PRODUCT NAME: BALOXAVIR MARBOXIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1500 20210108
3428170 LUC00198 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: BALOXAVIR MARBOXIL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1500 20210108
2620436 PA2021505 Lithuania ⤷  Free Forever Trial PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436 122021000017 Germany ⤷  Free Forever Trial PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436 301093 Netherlands ⤷  Free Forever Trial PRODUCT NAME: BALOXAVIR MARBOXIL, ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1500 20210108
2620436 C02620436/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
2620436 CA 2021 00004 Denmark ⤷  Free Forever Trial PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Express Scripts
Colorcon
McKinsey
AstraZeneca

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