XOFLUZA Drug Patent Profile

Which patents cover Xofluza, and what generic alternatives are available?

Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-seven patent family members in thirty-nine countries.

The generic ingredient in XOFLUZA is baloxavir marboxil. One supplier is listed for this compound. Additional details are available on the baloxavir marboxil profile page.

DrugPatentWatch^® Generic Entry Outlook for Xofluza

Xofluza was eligible for patent challenges on October 24, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 25, 2038. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for XOFLUZA

International Patents:	197
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	6
Patent Applications:	94
Drug Prices:	Drug price information for XOFLUZA
What excipients (inactive ingredients) are in XOFLUZA?	XOFLUZA excipients list
DailyMed Link:	XOFLUZA at DailyMed

See drug prices for XOFLUZA

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

NDA:

210854

Dosage:

TABLET;ORAL

NDA:

214410

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 XOFLUZA

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

Sponsor	Phase
University of Oxford	Phase 2
Weill Medical College of Cornell University	Phase 4
M.D. Anderson Cancer Center	Phase 2

See all XOFLUZA clinical trials

Pharmacology for XOFLUZA

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

Anatomical Therapeutic Chemical (ATC) Classes for XOFLUZA

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

Paragraph IV (Patent) Challenges for XOFLUZA

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 XOFLUZA

XOFLUZA is protected by ten US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XOFLUZA

FDA Regulatory Exclusivity protecting XOFLUZA

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			Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No			Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No			Y	Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No			Y

EU/EMA Drug Approvals for XOFLUZA

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

International Patents for XOFLUZA

When does loss-of-exclusivity occur for XOFLUZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

European Patent Office

Israel

Japan

Mexico

Poland

Singapore

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XOFLUZA around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20221540
South Korea	20220084425	치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
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)
World Intellectual Property Organization (WIPO)	2012039414
Moldova, Republic of	3428170

Supplementary Protection Certificates for XOFLUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2620436	7/2021	Austria		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		PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021
2620436	132021000000038	Italy		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	CA 2021 00004	Denmark		PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108
2620436	C02620436/01	Switzerland		PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020