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 twenty-six patent family members in forty countries.

One supplier is listed for this compound.

Summary for BALOXAVIR MARBOXIL

International Patents:	226
US Patents:	9
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	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No	⤷ 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
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	⤷ 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
European Patent Office	3498281	DÉRIVÉ DE PYRIDONE POLYCYCLIQUE SUBSTITUÉ ET COMPOSITION PHARMACEUTIQUE CONTENANT UN PROMÉDICAMENT DE CELUI-CI (SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PHARMACEUTICAL COMPOSITION CONTAINING PRODRUG THEREOF)	⤷ Sign Up
Morocco	45939	DÉRIVÉ DE PYRIDONE POLYCYCLIQUE SUBSTITUÉ ET COMPOSITION PHARMACEUTIQUE CONTENANT UN PROMÉDICAMENT DE CELUI-CI	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010110231		⤷ Sign Up
Russian Federation	2017137518	ЗАМЕЩЕННЫЕ ПОЛИЦИКЛИЧЕСКИЕ ПРОИЗВОДНЫЕ ПИРИДОНА И ИХ ПРОЛЕКАРСТВА	⤷ Sign Up
Croatia	P20181250		⤷ Sign Up
Taiwan	201103934	Substituted polycyclic carbamoylpyridone derivatives	⤷ Sign Up
China	113004304	经取代的多环性吡啶酮衍生物及其前药 (SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF)	⤷ 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	PA2021505,C2620436	Lithuania	⤷ Sign Up	PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436	5410/045	Ireland	⤷ Sign Up	PRODUCT NAME: BALOXAVIR MARBOXIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/20/1500 20210108
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	7/2021	Austria	⤷ Sign Up	PRODUCT NAME: BALOXAVIR MARBOXIL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1500 (MITTEILUNG) 20210108
3428170	C20210003 00390	Estonia	⤷ Sign Up	PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021
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
2620436	C02620436/01	Switzerland	⤷ Sign Up	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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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.