BALOXAVIR MARBOXIL - Generic Drug Details

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What are the generic sources for baloxavir marboxil and what is the scope of freedom to operate?

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

Baloxavir marboxil has two hundred and forty-seven patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for BALOXAVIR MARBOXIL

International Patents:	247
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	12
Patent Applications:	239
What excipients (inactive ingredients) are in BALOXAVIR MARBOXIL?	BALOXAVIR MARBOXIL excipients list
DailyMed Link:	BALOXAVIR MARBOXIL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BALOXAVIR MARBOXIL

Generic Entry Dates for BALOXAVIR MARBOXIL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for BALOXAVIR MARBOXIL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for BALOXAVIR MARBOXIL

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

Sponsor	Phase
Children's Hospital of Philadelphia	Phase 4
Weill Medical College of Cornell University	Phase 4
M.D. Anderson Cancer Center	Phase 2

See all BALOXAVIR MARBOXIL clinical trials

Pharmacology for BALOXAVIR MARBOXIL

Drug Class	Polymerase Acidic Endonuclease Inhibitor
Mechanism of Action	Chelating Activity Polymerase Acidic Endonuclease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BALOXAVIR MARBOXIL

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for BALOXAVIR MARBOXIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOFLUZA	Tablets	baloxavir marboxil	40 mg and 80 mg	210854	1	2022-10-24

US Patents and Regulatory Information for BALOXAVIR MARBOXIL

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>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

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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 influenzaXofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above.Post exposure prophylaxis of influenzaXofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year 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

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1248673		⤷ Sign Up
European Patent Office	4194459	PROCÉDÉ DE PRÉPARATION D'UN DÉRIVÉ DE PYRIDONE POLYCYCLIQUE SUBSTITUÉ ET CRISTAL DE CELUI-CI (PROCESS FOR PREPARING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL THEREOF)	⤷ Sign Up
Slovenia	4219508		⤷ Sign Up
Argentina	108812	PROCESO PARA PREPARAR UN DERIVADO DE PIRIDONA POLICÍCLICA SUSTITUIDA Y CRISTAL DEL MISMO	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BALOXAVIR MARBOXIL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2620436	C202130015	Spain	⤷ Sign Up	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	CR 2021 00004	Denmark	⤷ Sign Up	PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
2620436	CA 2021 00004	Denmark	⤷ Sign Up	PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
2620436	132021000000038	Italy	⤷ Sign Up	PRODUCT NAME: BALOXAVIR MARBOXIL O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(XOFLUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1500, 20210108
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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