NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as GENENTECH INC. It is marketed under 1 brand name, including XOFLUZA. Available in 6 different strengths, such as 20MG, 40MG, 2MG/ML and others, and administered through 2 routes including TABLET;ORAL, FOR SUSPENSION;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"58698","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"498203805dca4ba6acbb","publication_number":"US9815835B2","cleaned_patent_number":"9815835","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-14","publication_date":"2017-11-14","legal_status":"Granted"} | US9815835B2 Formulation | 14 Nov, 2017 | Granted | 14 Jun, 2030 | |
| {"application_id":"58729","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"498203805dca4ba6acbb","publication_number":"US8927710B2","cleaned_patent_number":"8927710","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-05","publication_date":"2015-01-06","legal_status":"Granted"} | US8927710B2 Formulation | 06 Jan, 2015 | Granted | 05 May, 2031 | |
| {"application_id":"58740","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"f23b7a236eac4c38a37c","publication_number":"US8987441B2","cleaned_patent_number":"8987441","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-21","publication_date":"2015-03-24","legal_status":"Granted"} | US8987441B2 Molecular Formulation | 24 Mar, 2015 | Granted | 21 Sep, 2031 | |
| {"application_id":"58691","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"ad7c575cbf8c4078a9e1","publication_number":"US10392406B2","cleaned_patent_number":"10392406","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-27","publication_date":"2019-08-27","legal_status":"Granted"} | US10392406B2 Molecular | 27 Aug, 2019 | Granted | 27 Apr, 2036 | |
| {"application_id":"58645","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"ad7c575cbf8c4078a9e1","publication_number":"US10633397B2","cleaned_patent_number":"10633397","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-27","publication_date":"2020-04-28","legal_status":"Granted"} | US10633397B2 | 28 Apr, 2020 | Granted | 27 Apr, 2036 | |
| {"application_id":"58796","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"a6b98feda6f54b2cb7de","publication_number":"US11306106B2","cleaned_patent_number":"11306106","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-09","publication_date":"2022-04-19","legal_status":"Patented case"} | US11306106B2 | 19 Apr, 2022 | Patented case | 09 Aug, 2037 | |
| {"application_id":"58772","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"a6b98feda6f54b2cb7de","publication_number":"US10759814B2","cleaned_patent_number":"10759814","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-09","publication_date":"2020-09-01","legal_status":"Granted"} | US10759814B2 Molecular Formulation | 01 Sep, 2020 | Granted | 09 Aug, 2037 | |
| {"application_id":"58801","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"4295472f42554be39cc4","publication_number":"US11261198B2","cleaned_patent_number":"11261198","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-09-25","publication_date":"2022-03-01","legal_status":"Granted"} | US11261198B2 Formulation | 01 Mar, 2022 | Granted | 25 Sep, 2038 | |
| {"application_id":"130748","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"","publication_number":"US12064438B2","cleaned_patent_number":"12064438","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-10-09","publication_date":"2024-08-20","legal_status":"Granted"} | US12064438B2 Formulation | 20 Aug, 2024 | Granted | 09 Oct, 2039 | |
| {"application_id":"122883","ingredient":"BALOXAVIR MARBOXIL","trade_name":"XOFLUZA","family_id":"","publication_number":"US11925648B2","cleaned_patent_number":"11925648","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-04-21","publication_date":"2024-03-12","legal_status":"Granted"} | US11925648B2 Formulation | 12 Mar, 2024 | Granted | 21 Apr, 2041 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.