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
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 |


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
Sponsor | Phase |
---|---|
University of Oxford | Phase 2 |
Weill Medical College of Cornell University | Phase 4 |
M.D. Anderson Cancer Center | Phase 2 |
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
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.
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
FDA Regulatory Exclusivity protecting XOFLUZA
NEW CHEMICAL ENTITY
Exclusivity 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 | 210854-003 | Mar 18, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 | ⤷ 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 | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | No | ⤷ 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 | ⤷ 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 |
---|---|---|---|
Croatia | P20221540 | ⤷ Try a Trial | |
South Korea | 20220084425 | 치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2012039414 | ⤷ Try a Trial | |
Moldova, Republic of | 3428170 | ⤷ 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 | 7/2021 | Austria | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021 |
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 | 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 | C02620436/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |