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
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 |


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