NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as NOVARTIS, APOTEX. It is marketed under 2 brand names, including TASIGNA, NILOTINIB HYDROCHLORIDE. Available in 3 different strengths, such as EQ 150MG BASE, EQ 50MG BASE, EQ 200MG BASE, and administered through 1 route including 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":"51088","ingredient":"NILOTINIB HYDROCHLORIDE","trade_name":"TASIGNA","family_id":"5b91489986ca48879eb5","publication_number":"US8389537B2","cleaned_patent_number":"8389537","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-18","publication_date":"2013-03-05","legal_status":"Granted"} | US8389537B2 | 05 Mar, 2013 | Granted | 18 Jan, 2027 | |
| {"application_id":"51151","ingredient":"NILOTINIB HYDROCHLORIDE","trade_name":"TASIGNA","family_id":"c65f3f1d5f294d9aa0a8","publication_number":"US8415363B2","cleaned_patent_number":"8415363","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-18","publication_date":"2013-04-09","legal_status":"Granted"} | US8415363B2 | 09 Apr, 2013 | Granted | 18 Jan, 2027 | |
| {"application_id":"51265","ingredient":"NILOTINIB HYDROCHLORIDE","trade_name":"TASIGNA","family_id":"a902a9b30a7847d8aacd","publication_number":"US8501760B2","cleaned_patent_number":"8501760","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-18","publication_date":"2013-08-06","legal_status":"Granted"} | US8501760B2 | 06 Aug, 2013 | Granted | 18 Jan, 2027 | |
| {"application_id":"51225","ingredient":"NILOTINIB HYDROCHLORIDE","trade_name":"TASIGNA","family_id":"a902a9b30a7847d8aacd","publication_number":"US8293756B2","cleaned_patent_number":"8293756","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-03-25","publication_date":"2012-10-23","legal_status":"Granted"} | US8293756B2 | 23 Oct, 2012 | Granted | 25 Mar, 2028 | |
| {"application_id":"51044","ingredient":"NILOTINIB HYDROCHLORIDE","trade_name":"TASIGNA","family_id":"5b91489986ca48879eb5","publication_number":"US8163904B2","cleaned_patent_number":"8163904","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-23","publication_date":"2012-04-24","legal_status":"Granted"} | US8163904B2 | 24 Apr, 2012 | Granted | 23 Feb, 2029 | |
| {"application_id":"119067","ingredient":"NILOTINIB HYDROCHLORIDE","trade_name":"TASIGNA","family_id":"da3dc5c8351f45bdb572","publication_number":"US9061029B2","cleaned_patent_number":"9061029","drug_product_flag":"-","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-10-07","publication_date":"2015-06-23","legal_status":"Granted"} | US9061029B2 | 23 Jun, 2015 | Granted | 07 Oct, 2032 |
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.