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Last Updated: October 7, 2022

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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baloxavir marboxil has one hundred and seventy-three patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for baloxavir marboxil
International Patents:173
US Patents:8
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 35
Clinical Trials: 10
Patent Applications: 188
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
Weill Medical College of Cornell UniversityPhase 4
M.D. Anderson Cancer CenterPhase 2
University of WashingtonPhase 4

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

EU/EMA Drug Approvals for baloxavir marboxil

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Roche Registration GmbH Xofluza baloxavir marboxil EMEA/H/C/004974
Treatment of influenza, Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 12 years and above., , Post exposure prophylaxis of influenza, Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 12 years and above. Xofluza should be used in accordance with official recommendations.,
Authorised no no no 2021-01-07
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for baloxavir marboxil

Country Patent Number Title Estimated Expiration
Japan WO2012039414 置換された多環性カルバモイルピリドン誘導体のプロドラッグ See Plans and Pricing
Japan 6212678 See Plans and Pricing
Canada 3033180 DERIVE DE PYRIDONE POLYCYCLIQUE SUBSTITUE ET COMPOSITION PHARMACEUTIQUE CONTENANT UN PROMEDICAMENT DE CELUI-CI (PHARMACEUTICAL COMPOSITIONS CONTAINING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVES AND PRODRUG THEREOF) See Plans and Pricing
Japan 5971830 See Plans and Pricing
Canada 2984130 DERIVE DE PYRIDONE POLYCYCLIQUE SUBSTITUE ET PROMEDICAMENTS DE CELUI-CI (SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF) See Plans and Pricing
Canada 3027840 METHODES DE PRODUCTION DE DERIVES SUBSTITUES DE PYRIDONE POLYCYCLIQUE ET CRISTAL CORRESPONDANT (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME) See Plans and Pricing
Israel 255295 נגזרות 11-מותמרות של 8,7-דיפלואורו-11,6-דיהידרובנזו[b,e]תיאפין (11-substituted-7,8-difluoro-6,11-dihydrodibenzo[b,e]thiepine derivatives) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for baloxavir marboxil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2620436 301093 Netherlands See Plans and Pricing PRODUCT NAME: BALOXAVIR MARBOXIL, ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1500 20210108
2620436 2021C/510 Belgium See Plans and Pricing PRODUCT NAME: BALOXAVIR MARBOXIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1500 20210108
2620436 C202130015 Spain See Plans and Pricing PRODUCT NAME: BALOXAVIR MARBOXIL; NATIONAL AUTHORISATION NUMBER: EU/1/20/1500; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1500; DATE OF FIRST AUTHORISATION IN EEA: 20210107
2620436 PA2021505 Lithuania See Plans and Pricing PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436 122021000017 Germany See Plans and Pricing PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436 CR 2021 00004 Denmark See Plans and Pricing PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
2620436 C02620436/01 Switzerland See Plans and Pricing PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
>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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