NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 26 pharmaceutical companies such as SANOFI AVENTIS US, HOSPIRA INC, SUN PHARM and others. It is marketed under 5 brand names, including TAXOTERE, DOCETAXEL, DOCEFREZ and others. Available in 16 different strengths, such as 80MG/4ML (20MG/ML), 20MG/ML (20MG/ML), 20MG/2ML (10MG/ML) and others, and administered through 2 routes including INJECTABLE;INJECTION, SOLUTION;INTRAVENOUS.
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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":"61693","ingredient":"DOCETAXEL","trade_name":"DOCETAXEL","family_id":"577d085e19794135b2dc","publication_number":"US10842770B2","cleaned_patent_number":"10842770","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-07","publication_date":"2020-11-24","legal_status":"Granted"} | US10842770B2 Formulation | 24 Nov, 2020 | Granted | 07 Aug, 2031 | |
| {"application_id":"61686","ingredient":"DOCETAXEL","trade_name":"DOCETAXEL","family_id":"554a8ec7f41545d8b767","publication_number":"US8940786B2","cleaned_patent_number":"8940786","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-30","publication_date":"2015-01-27","legal_status":"Patented case"} | US8940786B2 Formulation | 27 Jan, 2015 | Patented case | 30 Sep, 2033 | |
| {"application_id":"61664","ingredient":"DOCETAXEL","trade_name":"DOCETAXEL","family_id":"554a8ec7f41545d8b767","publication_number":"US9763880B2","cleaned_patent_number":"9763880","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-30","publication_date":"2017-09-19","legal_status":"Granted"} | US9763880B2 | 19 Sep, 2017 | Granted | 30 Sep, 2033 | |
| {"application_id":"61687","ingredient":"DOCETAXEL","trade_name":"DOCETAXEL","family_id":"554a8ec7f41545d8b767","publication_number":"US9308195B2","cleaned_patent_number":"9308195","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-30","publication_date":"2016-04-12","legal_status":"Granted"} | US9308195B2 Formulation | 12 Apr, 2016 | Granted | 30 Sep, 2033 | |
| {"application_id":"115782","ingredient":"DOCETAXEL","trade_name":"DOCIVYX","family_id":"2393287f13fd4f9aa38a","publication_number":"US10398785B2","cleaned_patent_number":"10398785","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-14","publication_date":"2019-09-03","legal_status":"Granted"} | US10398785B2 Formulation | 03 Sep, 2019 | Granted | 14 Mar, 2036 | |
| {"application_id":"138485","ingredient":"DOCETAXEL","trade_name":"BEIZRAY","family_id":"","publication_number":"US12090135B2","cleaned_patent_number":"12090135","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-16","publication_date":"2024-09-17","legal_status":"Granted"} | US12090135B2 Formulation | 17 Sep, 2024 | Granted | 16 May, 2036 | |
| {"application_id":"138484","ingredient":"DOCETAXEL","trade_name":"BEIZRAY","family_id":"","publication_number":"US12090134B2","cleaned_patent_number":"12090134","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-16","publication_date":"2024-09-17","legal_status":"Granted"} | US12090134B2 Formulation | 17 Sep, 2024 | Granted | 16 May, 2036 | |
| {"application_id":"138483","ingredient":"DOCETAXEL","trade_name":"BEIZRAY","family_id":"","publication_number":"US11419842B2","cleaned_patent_number":"11419842","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-16","publication_date":"2022-08-23","legal_status":"Granted"} | US11419842B2 Formulation | 23 Aug, 2022 | Granted | 16 May, 2036 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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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.