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 forty-seven 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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Summary for XOFLUZA
| International Patents: | 247 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 42 |
| Clinical Trials: | 7 |
| Patent Applications: | 65 |
| 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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted polycyclic pyridone derivatives and prodrugs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR TREATING INFLUENZA
Substituted polycyclic pyridone derivatives and prodrugs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process for preparing substituted polycyclic pyridone derivative and crystal thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR TREATING INFLUENZA
Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted polycyclic carbamoylpyridone derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted polycyclic carbamoyl pyridone derivative prodrug
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted polycyclic carbamolypyridone derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Genentech Inc | XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410-001 | Nov 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-001 | Oct 24, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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
Patent: PROCESO PARA PREPARAR UN DERIVADO DE PIRIDONA POLICÍCLICA SUSTITUIDA Y CRISTAL DEL MISMO
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 17282305
Patent: Method for producing substituted polycyclic pyridone derivative and crystal of same
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2018076600
Patent: processo para a preparação de derivado de piridona policíclica substituída e cristal do mesmo
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 27840
Patent: METHODES DE PRODUCTION DE DERIVES SUBSTITUES DE PYRIDONE POLYCYCLIQUE ET CRISTAL CORRESPONDANT (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷ Sign Up
China
Patent: 9311911
Patent: 用于制备取代多环吡啶酮衍生物及其晶体的方法 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 3717198
Patent: 用于制备取代多环吡啶酮衍生物及其晶体的方法 (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0221540
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 73629
Patent: MÉTHODES DE PRODUCTION DE DÉRIVÉS SUBSTITUÉS DE PYRIDONE POLYCYCLIQUE ET CRISTAL CORRESPONDANT (METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 94459
Patent: PROCÉDÉ DE PRÉPARATION D'UN DÉRIVÉ DE PYRIDONE POLYCYCLIQUE SUBSTITUÉ ET CRISTAL DE CELUI-CI (PROCESS FOR PREPARING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL THEREOF)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3812
Patent: תהליך להכנת נגזרת פוליציקלית של פירידון מותמרת וגביש הימנה (Process for preparing substituted polycyclic pyridone derivative and crystal thereof)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 12678
Estimated Expiration: ⤷ Sign Up
Patent: 59077
Estimated Expiration: ⤷ Sign Up
Patent: 18024682
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 (METHOD OF PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE, AND CRYSTAL OF THE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Poland
Patent: 73629
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201810655Q
Patent: METHOD FOR PRODUCING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL OF SAME
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 73629
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2447711
Estimated Expiration: ⤷ Sign Up
Patent: 2586854
Estimated Expiration: ⤷ Sign Up
Patent: 190017991
Patent: 치환된 다환성 피리돈 유도체의 제조 방법 및 그의 결정
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Spain
Patent: 36077
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 50188
Estimated Expiration: ⤷ Sign Up
Patent: 1802097
Patent: Process for preparing substituted polycyclic pyridone derivative and crystal thereof
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Hong Kong | 1248673 | ⤷ Sign Up | |
| European Patent Office | 4194459 | PROCÉDÉ DE PRÉPARATION D'UN DÉRIVÉ DE PYRIDONE POLYCYCLIQUE SUBSTITUÉ ET CRISTAL DE CELUI-CI (PROCESS FOR PREPARING SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND CRYSTAL THEREOF) | ⤷ Sign Up |
| Slovenia | 4219508 | ⤷ Sign Up | |
| Argentina | 108812 | PROCESO PARA PREPARAR UN DERIVADO DE PIRIDONA POLICÍCLICA SUSTITUIDA Y CRISTAL DEL MISMO | ⤷ Sign Up |
| Australia | 2017310774 | Substituted polycyclic pyridone derivative and pharmaceutical composition containing prodrug thereof | ⤷ Sign Up |
| South Korea | 20110132462 | PROCESS FOR PRODUCING PYRONE AND PYRIDONE DERIVATIVES | ⤷ Sign Up |
| 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) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XOFLUZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2620436 | C202130015 | Spain | ⤷ Sign Up | PRODUCT NAME: BALOXAVIR MARBOXIL; NATIONAL AUTHORISATION NUMBER: EU/1/20/1500; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1500; DATE OF FIRST AUTHORISATION IN EEA: 20210107 |
| 2620436 | CR 2021 00004 | Denmark | ⤷ Sign Up | PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108 |
| 2620436 | CA 2021 00004 | Denmark | ⤷ Sign Up | PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108 |
| 2620436 | 132021000000038 | Italy | ⤷ Sign Up | 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 | C02620436/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020 |
| 2620436 | 301093 | Netherlands | ⤷ Sign Up | PRODUCT NAME: BALOXAVIR MARBOXIL, ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1500 20210108 |
| 2620436 | 5410/045 | Ireland | ⤷ Sign Up | PRODUCT NAME: BALOXAVIR MARBOXIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/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.
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