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 ten patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and fifty-four patent family members in forty-one 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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Questions you can ask:
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Summary for XOFLUZA
International Patents: | 254 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 7 |
Patent Applications: | 73 |
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 |
---|---|
Children's Hospital of Philadelphia | Phase 4 |
University of Oxford | Phase 2 |
Weill Medical College of Cornell University | Phase 4 |
Pharmacology for XOFLUZA
Drug Class | Polymerase Acidic Endonuclease Inhibitor |
Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
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 twelve US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOFLUZA is ⤷ Free Trial.
This potential generic entry date is based on patent ⤷ Free 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.
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 | ⤷ Free Trial | ⤷ Free Trial | Y | Y | ⤷ Free Trial | ||
Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | No | ⤷ Free Trial | ⤷ Free Trial | Y | Y | ⤷ Free Trial | ||
Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | No | ⤷ Free Trial | ⤷ Free Trial | Y | Y | ⤷ Free 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: ⤷ Free Trial
Australia
Patent: 17282305
Estimated Expiration: ⤷ Free Trial
Brazil
Patent: 2018076600
Estimated Expiration: ⤷ Free Trial
Canada
Patent: 27840
Estimated Expiration: ⤷ Free Trial
China
Patent: 9311911
Estimated Expiration: ⤷ Free Trial
Patent: 3717198
Estimated Expiration: ⤷ Free Trial
Croatia
Patent: 0221540
Estimated Expiration: ⤷ Free Trial
European Patent Office
Patent: 73629
Estimated Expiration: ⤷ Free Trial
Patent: 94459
Estimated Expiration: ⤷ Free Trial
Israel
Patent: 3812
Estimated Expiration: ⤷ Free Trial
Japan
Patent: 2017221869
Patent: 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
Estimated Expiration: ⤷ Free Trial
Patent: 12678
Estimated Expiration: ⤷ Free Trial
Patent: 59077
Estimated Expiration: ⤷ Free Trial
Patent: 18024682
Estimated Expiration: ⤷ Free Trial
Mexico
Patent: 18016267
Patent: METODO PARA PRODUCIR DERIVADO DE PIRIDONA POLICICLICA SUSTITUIDA Y CRISTAL DEL MISMO. (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME.)
Estimated Expiration: ⤷ Free Trial
Poland
Patent: 73629
Estimated Expiration: ⤷ Free Trial
Singapore
Patent: 201810655Q
Patent: METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME
Estimated Expiration: ⤷ Free Trial
Slovenia
Patent: 73629
Estimated Expiration: ⤷ Free Trial
South Korea
Patent: 2447711
Estimated Expiration: ⤷ Free Trial
Patent: 2586854
Estimated Expiration: ⤷ Free Trial
Patent: 190017991
Patent: 치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정
Estimated Expiration: ⤷ Free Trial
Patent: 220084425
Patent: 치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷ Free Trial
Spain
Patent: 36077
Estimated Expiration: ⤷ Free Trial
Taiwan
Patent: 50188
Estimated Expiration: ⤷ Free Trial
Patent: 1802097
Patent: Process for preparing substituted polycyclic pyridone derivative and crystal thereof
Estimated Expiration: ⤷ Free 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 |
---|---|---|---|
Spain | 2938877 | ⤷ Free Trial | |
Morocco | 45939 | DÉRIVÉ DE PYRIDONE POLYCYCLIQUE SUBSTITUÉ ET COMPOSITION PHARMACEUTIQUE CONTENANT UN PROMÉDICAMENT DE CELUI-CI | ⤷ Free Trial |
European Patent Office | 3785716 | FORMULATION SOLIDE PRÉSENTANT UNE EXCELLENTE STABILITÉ (SOLID FORMULATION HAVING EXCELLENT STABILITY) | ⤷ Free Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XOFLUZA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2620436 | 132021000000038 | Italy | ⤷ Free 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 | 122021000017 | Germany | ⤷ Free Trial | PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107 |
3428170 | C20210003 00390 | Estonia | ⤷ Free Trial | PRODUCT NAME: BALOKSAVIIRMARBOKSIIL;REG NO/DATE: EU/1/20/1500 08.01.2021 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Xofluza
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