NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 14 pharmaceutical companies such as SEBELA IRELAND LTD, MYLAN PHARMS INC, AMNEAL PHARMS and others. It is marketed under 3 brand names, including ONMEL, ITRACONAZOLE, TOLSURA. Available in 4 different strengths, such as 200MG, 100MG, 10MG/ML and others, and administered through 3 routes including TABLET;ORAL, CAPSULE;ORAL, SOLUTION;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":"97352","ingredient":"ITRACONAZOLE","trade_name":"ONMEL","family_id":"641020cff7b248b7ba24","publication_number":"US8486456B2","cleaned_patent_number":"8486456","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-03","publication_date":"2013-07-16","legal_status":"Granted"} | US8486456B2 Formulation | 16 Jul, 2013 | Granted | 03 Oct, 2028 | |
| {"application_id":"51550","ingredient":"ITRACONAZOLE","trade_name":"TOLSURA","family_id":"66703ea624bd4e9081c2","publication_number":"US10463740B2","cleaned_patent_number":"10463740","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-21","publication_date":"2019-11-05","legal_status":"Granted"} | US10463740B2 Formulation | 05 Nov, 2019 | Granted | 21 Jun, 2033 | |
| {"application_id":"51569","ingredient":"ITRACONAZOLE","trade_name":"TOLSURA","family_id":"66703ea624bd4e9081c2","publication_number":"US10806792B2","cleaned_patent_number":"10806792","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-21","publication_date":"2020-10-20","legal_status":"Granted"} | US10806792B2 Formulation | 20 Oct, 2020 | Granted | 21 Jun, 2033 | |
| {"application_id":"51566","ingredient":"ITRACONAZOLE","trade_name":"TOLSURA","family_id":"66703ea624bd4e9081c2","publication_number":"US8921374B2","cleaned_patent_number":"8921374","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-21","publication_date":"2014-12-30","legal_status":"Granted"} | US8921374B2 Formulation | 30 Dec, 2014 | Granted | 21 Jun, 2033 | |
| {"application_id":"51567","ingredient":"ITRACONAZOLE","trade_name":"TOLSURA","family_id":"66703ea624bd4e9081c2","publication_number":"US9272046B2","cleaned_patent_number":"9272046","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-21","publication_date":"2016-03-01","legal_status":"Granted"} | US9272046B2 Formulation | 01 Mar, 2016 | Granted | 21 Jun, 2033 | |
| {"application_id":"51568","ingredient":"ITRACONAZOLE","trade_name":"TOLSURA","family_id":"66703ea624bd4e9081c2","publication_number":"US9713642B2","cleaned_patent_number":"9713642","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-21","publication_date":"2017-07-25","legal_status":"Granted"} | US9713642B2 | 25 Jul, 2017 | Granted | 21 Jun, 2033 |
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.