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Last Updated: April 17, 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baloxavir marboxil has one hundred and ninety-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for BALOXAVIR MARBOXIL

International Patents:	197
US Patents:	8
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
University of Washington	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	210854-002	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	Y			⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		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	210854-001	Oct 24, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		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
Spain	2938877		⤷ Try a Trial
Hong Kong	1259624	抗流感多環吡啶酮衍生物及其前藥 (ANTI-INFLUENZA POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF)	⤷ Try a Trial
Brazil	112013006722	profármaco de derivado de carbamoilpiridona policíclica substituída	⤷ Try a Trial
Taiwan	I518085		⤷ Try a Trial
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	⤷ Try a Trial
Ukraine	123725	ЗАМІЩЕНІ ПОЛІЦИКЛІЧНІ ПОХІДНІ ПІРИДОНУ ТА ЇХ ПРОЛІКИ (SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF)	⤷ Try a Trial
New Zealand	736259	Substituted polycyclic pyridone derivative and prodrugs thereof	⤷ 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	PA2021505	Lithuania	⤷ Try a Trial	PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436	CR 2021 00004	Denmark	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/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	C02620436/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
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
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
>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.