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Last Updated: June 27, 2022

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 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

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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
Drug patent expirations by year for XOFLUZA
Drug Prices for XOFLUZA

See drug prices for XOFLUZA

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Weill Medical College of Cornell UniversityPhase 4
M.D. Anderson Cancer CenterPhase 2
University of WashingtonPhase 4

See all XOFLUZA clinical trials

US Patents and Regulatory Information for XOFLUZA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOFLUZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted polycyclic pyridone derivatives and prodrugs thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING INFLUENZA

Substituted polycyclic pyridone derivatives and prodrugs thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA

Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for preparing substituted polycyclic pyridone derivative and crystal thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted polycyclic carbamoylpyridone derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted polycyclic carbamoyl pyridone derivative prodrug
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted polycyclic carbamolypyridone derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XOFLUZA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 48 HOURS AND ARE AT HIGH RISK OF DEVELOPING INFLUENZA-RELATED COMPLICATIONS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-003 Mar 18, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 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
>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: See Plans and Pricing

Australia

Patent: 17282305
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2018076600
Estimated Expiration: See Plans and Pricing

Canada

Patent: 27840
Estimated Expiration: See Plans and Pricing

China

Patent: 9311911
Estimated Expiration: See Plans and Pricing

Patent: 3717198
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 73629
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3812
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2017221869
Estimated Expiration: See Plans and Pricing

Patent: 12678
Estimated Expiration: See Plans and Pricing

Patent: 59077
Estimated Expiration: See Plans and Pricing

Patent: 18024682
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18016267
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201810655Q
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 190017991
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 50188
Estimated Expiration: See Plans and Pricing

Patent: 1802097
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
Japan 6004552 See Plans and Pricing
Singapore 11201900869Q PHARMACEUTICAL COMPOSITIONS CONTAINING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVES AND PRODRUG THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XOFLUZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2620436 C02620436/01 Switzerland See Plans and Pricing PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020
2620436 122021000017 Germany See Plans and Pricing PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107
2620436 132021000000038 Italy See Plans and Pricing PRODUCT NAME: BALOXAVIR MARBOXIL O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(XOFLUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1500, 20210108
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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Medtronic

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.