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Last Updated: April 24, 2024

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 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
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

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	210854-003	Mar 18, 2021		RX	Yes	Yes	⤷ 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	Y	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				⤷ 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	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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	20190017991	치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정	⤷ Try a Trial
Poland	2444400		⤷ Try a Trial
Morocco	46300	DÉRIVÉ DE PYRIDONE POLYCYCLIQUE ANTI-GRIPPAL ET PROMÉDICAMENT DE CELUI-CI	⤷ Try a Trial
France	21C1012		⤷ Try a Trial
Canada	2812363	PROMEDICAMENT DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE SUBSTITUEE (SUBSTITUTED POLYCYCLIC CARBAMOYL PYRIDONE DERIVATIVE PRODRUG)	⤷ 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
3428170	C20210003 00390	Estonia	⤷ Try a Trial	PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021
2620436	2021C/510	Belgium	⤷ Try a Trial	PRODUCT NAME: BALOXAVIR MARBOXIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1500 20210108
2620436	PA2021505,C2620436	Lithuania	⤷ Try a Trial	PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436	C02620436/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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