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Last Updated: May 9, 2024

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

Baloxavir marboxil has two hundred and eighteen patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for BALOXAVIR MARBOXIL

International Patents:	218
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	10
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL
Generic Entry Dates for BALOXAVIR MARBOXIL^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
Weill Medical College of Cornell University	Phase 4
M.D. Anderson Cancer Center	Phase 2
Genentech, Inc.	Phase 4

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

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	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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
South Korea	20170131651	치환된 다환성 피리돈 유도체 및 그의 프로드러그	⤷ Try a Trial
Norway	2021011		⤷ Try a Trial
France	21C1012		⤷ Try a Trial
Chile	2020002032	Cristal de un compuesto derivado de 7,8-difluoro-6,11-dihidrodibenzotiepina, composición farmacéutica, útil en reducir el tiempo de alivio de los síntomas de la influenza para tratar y/o prevenir una infección provocada por el virus de la influenza. (divisional solicitud 201900325).	⤷ Try a Trial
Portugal	3428170		⤷ Try a Trial
Taiwan	I711621		⤷ Try a Trial
Taiwan	I750188		⤷ Try a Trial
>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	21C1012	France	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1500 20210108
2620436	SPC/GB21/036	United Kingdom	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF.; REGISTERED: UK EU/1/20/1500(FOR NI) 20210108; UK FURTHER MAS ON IPSUM 20210108
2620436	122021000017	Germany	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107
3428170	LUC00198	Luxembourg	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1500 20210108
2620436	132021000000038	Italy	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(XOFLUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1500, 20210108
2620436	301093	Netherlands	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL, ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1500 20210108
3428170	C20210003 00390	Estonia	⤷ Try a Trial	PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.