NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as BAYER HEALTHCARE. It is marketed under 1 brand name, including NUBEQA. Available in 1 different strength, such as 300MG, and administered through 1 route including TABLET;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":"34431","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"2f6184d8824248bd840a","publication_number":"US9657003B2","cleaned_patent_number":"9657003","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-27","publication_date":"2017-05-23","legal_status":"Granted"} | US9657003B2 Molecular Formulation | 23 May, 2017 | Granted | 27 Oct, 2030 | |
| {"application_id":"34433","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"2f6184d8824248bd840a","publication_number":"US10711013B2","cleaned_patent_number":"10711013","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-27","publication_date":"2020-07-14","legal_status":"Granted"} | US10711013B2 Molecular Formulation | 14 Jul, 2020 | Granted | 27 Oct, 2030 | |
| {"application_id":"34434","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"2f6184d8824248bd840a","publication_number":"US11046713B2","cleaned_patent_number":"11046713","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-27","publication_date":"2021-06-29","legal_status":"Granted"} | US11046713B2 Molecular | 29 Jun, 2021 | Granted | 27 Oct, 2030 | |
| {"application_id":"34430","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"2f6184d8824248bd840a","publication_number":"US8975254B2","cleaned_patent_number":"8975254","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-25","publication_date":"2015-03-10","legal_status":"Granted"} | US8975254B2 Molecular Formulation | 10 Mar, 2015 | Granted | 25 Mar, 2033 | |
| {"application_id":"34972","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"345006d05b8b4202acd6","publication_number":"US10835515B2","cleaned_patent_number":"10835515","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-01-28","publication_date":"2020-11-17","legal_status":"Granted"} | US10835515B2 Formulation | 17 Nov, 2020 | Granted | 28 Jan, 2036 | |
| {"application_id":"1753","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"345006d05b8b4202acd6","publication_number":"US10010530B2","cleaned_patent_number":"10010530","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-01-28","publication_date":"2018-07-03","legal_status":"Granted"} | US10010530B2 Molecular | 03 Jul, 2018 | Granted | 28 Jan, 2036 | |
| {"application_id":"34970","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"345006d05b8b4202acd6","publication_number":"US10383853B2","cleaned_patent_number":"10383853","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-01-28","publication_date":"2019-08-20","legal_status":"Granted"} | US10383853B2 Molecular | 20 Aug, 2019 | Granted | 28 Jan, 2036 | |
| {"application_id":"1758","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"28a913e864e442dab2e7","publication_number":"US11168058B2","cleaned_patent_number":"11168058","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-02-27","publication_date":"2021-11-09","legal_status":"Granted"} | US11168058B2 Molecular Formulation | 09 Nov, 2021 | Granted | 27 Feb, 2038 | |
| {"application_id":"109333","ingredient":"DAROLUTAMIDE","trade_name":"NUBEQA","family_id":"d47cb6a0ca884665be4a","publication_number":"US20220362216A1","cleaned_patent_number":"12329742","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-05-14","publication_date":"2022-11-17","legal_status":"Pending"} | US12329742B2 Formulation | 17 Nov, 2022 | Pending | 14 May, 2042 |
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.