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Last Updated: March 28, 2024

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XOFLUZA Drug Patent Profile


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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

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  Try a Trial

Summary for XOFLUZA
International Patents:197
US Patents:8
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 42
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
Drug patent expirations by year for XOFLUZA
Drug Prices for XOFLUZA

See drug prices for XOFLUZA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XOFLUZA
Generic Entry Dates for XOFLUZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for XOFLUZA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of OxfordPhase 2
Weill Medical College of Cornell UniversityPhase 4
M.D. Anderson Cancer CenterPhase 2

See all XOFLUZA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOFLUZA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Substituted polycyclic pyridone derivatives and prodrugs thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted polycyclic pyridone derivatives and prodrugs thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR TREATING INFLUENZA

Substituted polycyclic pyridone derivatives and prodrugs thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA

Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Process for preparing substituted polycyclic pyridone derivative and crystal thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR TREATING INFLUENZA

Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA

Substituted polycyclic carbamoylpyridone derivative
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted polycyclic carbamoyl pyridone derivative prodrug
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted polycyclic carbamolypyridone derivative
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
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 210854-003 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 FOR SUSPENSION;ORAL 214410-001 Nov 23, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 TABLET;ORAL 210854-003 Mar 18, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y 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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 8812
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 17282305
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2018076600
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 27840
Estimated Expiration: ⤷  Try a Trial

China

Patent: 9311911
Estimated Expiration: ⤷  Try a Trial

Patent: 3717198
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0221540
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 73629
Estimated Expiration: ⤷  Try a Trial

Patent: 94459
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3812
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2017221869
Estimated Expiration: ⤷  Try a Trial

Patent: 12678
Estimated Expiration: ⤷  Try a Trial

Patent: 59077
Estimated Expiration: ⤷  Try a Trial

Patent: 18024682
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 18016267
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 73629
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201810655Q
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 73629
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2447711
Estimated Expiration: ⤷  Try a Trial

Patent: 2586854
Estimated Expiration: ⤷  Try a Trial

Patent: 190017991
Estimated Expiration: ⤷  Try a Trial

Patent: 220084425
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 36077
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 50188
Estimated Expiration: ⤷  Try a Trial

Patent: 1802097
Estimated Expiration: ⤷  Try a Trial

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
Slovenia 2620436 ⤷  Try a Trial
South Korea 102447711 ⤷  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
Ukraine 125218 ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ, ЩО МІСТЯТЬ ЗАМІЩЕНІ ПОЛІЦИКЛІЧНІ ПІРИДОНОВІ ПОХІДНІ ТА ЇХ ПРОЛІКИ (SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PHARMACEUTICAL COMPOSITION CONTAINING PRODRUG THEREOF) ⤷  Try a Trial
South Africa 201707111 SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF ⤷  Try a Trial
Japan 2018024682 置換された多環性ピリドン誘導体の製造方法およびその結晶 (METHOD OF PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE, AND CRYSTAL OF THE DERIVATIVE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XOFLUZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 C02620436/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
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
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 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
>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.