NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as NOVARTIS. It is marketed under 1 brand name, including TAFINLAR. Available in 3 different strengths, such as EQ 50MG BASE, EQ 75MG BASE, EQ 10MG BASE, and administered through 2 routes including CAPSULE;ORAL, TABLET, 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":"50785","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"9b54bca6e5a84d84ace7","publication_number":"US8835443B2","cleaned_patent_number":"8835443","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-10","publication_date":"2014-09-16","legal_status":"Granted"} | US8835443B2 | 16 Sep, 2014 | Granted | 10 Dec, 2025 | |
| {"application_id":"50839","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"2e9612946ce543f788ca","publication_number":"US9233956B2","cleaned_patent_number":"9233956","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-11-04","publication_date":"2016-01-12","legal_status":"Granted"} | US9233956B2 | 12 Jan, 2016 | Granted | 04 Nov, 2029 | |
| {"application_id":"50872","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"2e9612946ce543f788ca","publication_number":"US7994185B2","cleaned_patent_number":"7994185","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-20","publication_date":"2011-08-09","legal_status":"Granted"} | US7994185B2 | 09 Aug, 2011 | Granted | 20 Jul, 2030 | |
| {"application_id":"50873","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"2e9612946ce543f788ca","publication_number":"US8415345B2","cleaned_patent_number":"8415345","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-20","publication_date":"2013-04-09","legal_status":"Granted"} | US8415345B2 | 09 Apr, 2013 | Granted | 20 Jul, 2030 | |
| {"application_id":"50882","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"e7b9ef6953244aa98bd6","publication_number":"US8703781B2","cleaned_patent_number":"8703781","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-15","publication_date":"2014-04-22","legal_status":"Granted"} | US8703781B2 | 22 Apr, 2014 | Granted | 15 Apr, 2031 | |
| {"application_id":"50913","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"e7b9ef6953244aa98bd6","publication_number":"US8952018B2","cleaned_patent_number":"8952018","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-15","publication_date":"2015-02-10","legal_status":"Granted"} | US8952018B2 | 10 Feb, 2015 | Granted | 15 Apr, 2031 | |
| {"application_id":"50919","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"82fb077bb51141d1b46e","publication_number":"US10869869B2","cleaned_patent_number":"10869869","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-28","publication_date":"2020-12-22","legal_status":"Granted"} | US10869869B2 | 22 Dec, 2020 | Granted | 28 Feb, 2034 | |
| {"application_id":"116364","ingredient":"DABRAFENIB MESYLATE","trade_name":"TAFINLAR","family_id":"9ba7d05398cc4ebd80d1","publication_number":"US11504333B2","cleaned_patent_number":"11504333","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-29","publication_date":"2022-11-22","legal_status":"Granted"} | US11504333B2 | 22 Nov, 2022 | Granted | 29 Dec, 2038 |
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.