NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as PF PRISM CV, ALEMBIC. It is marketed under 2 brand names, including BOSULIF, BOSUTINIB MONOHYDRATE. Available in 4 different strengths, such as EQ 100MG BASE, EQ 500MG BASE, EQ 400MG BASE and others, and administered through 2 routes including TABLET;ORAL, CAPSULE;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":"91155","ingredient":"BOSUTINIB MONOHYDRATE","trade_name":"BOSULIF","family_id":"e5520545227c441f8835","publication_number":"US7417148B2","cleaned_patent_number":"7417148","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-11","publication_date":"2008-08-26","legal_status":"Granted"} | US7417148B2 | 26 Aug, 2008 | Granted | 11 Jun, 2026 | |
| {"application_id":"91172","ingredient":"BOSUTINIB MONOHYDRATE","trade_name":"BOSULIF","family_id":"e5520545227c441f8835","publication_number":"US7919625B2","cleaned_patent_number":"7919625","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-11","publication_date":"2011-04-05","legal_status":"Granted"} | US7919625B2 | 05 Apr, 2011 | Granted | 11 Jun, 2026 | |
| {"application_id":"91215","ingredient":"BOSUTINIB MONOHYDRATE","trade_name":"BOSULIF","family_id":"beb61a301c6546e6b5b5","publication_number":"US7767678B2","cleaned_patent_number":"7767678","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-23","publication_date":"2010-08-03","legal_status":"Granted"} | US7767678B2 | 03 Aug, 2010 | Granted | 23 May, 2027 | |
| {"application_id":"91177","ingredient":"BOSUTINIB MONOHYDRATE","trade_name":"BOSULIF","family_id":"5523baa82eda4a58a3e1","publication_number":"US11103497B2","cleaned_patent_number":"11103497","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-08-28","publication_date":"2021-08-31","legal_status":"Patented case"} | US11103497B2 | 31 Aug, 2021 | Patented case | 28 Aug, 2034 |
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.