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 seven patents protecting this drug.

This drug has one hundred and seventy patent family members in thirty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Xofluza

Xofluza will be eligible for patent challenges on October 24, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for XOFLUZA

International Patents:	170
US Patents:	7
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	5
Patent Applications:	62
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 Generic Entry Opportunity 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
Weill Medical College of Cornell University	Phase 4
M.D. Anderson Cancer Center	Phase 2
University of Washington	Phase 4

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

US Patents and Regulatory Information for XOFLUZA

XOFLUZA is protected by eight US patents and two FDA Regulatory Exclusivities.

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	No				Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	Yes
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		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 12 years and above.Post exposure prophylaxis of influenzaXofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 12 years 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

European Patent Office

Israel

Japan

Mexico

Singapore

South Korea

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
Australia	2016256125	Substituted polycyclic pyridone derivative and prodrug thereof
Japan	6004552
Singapore	11201900869Q	PHARMACEUTICAL COMPOSITIONS CONTAINING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVES AND PRODRUG THEREOF

Supplementary Protection Certificates for XOFLUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2620436	C02620436/01	Switzerland		PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
2620436	122021000017	Germany		PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107
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