NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as XCOVERY. It is marketed under 1 brand name, including ENSACOVE. Available in 2 different strengths, such as EQ 25MG BASE, EQ 100MG 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":"139371","ingredient":"ENSARTINIB HYDROCHLORIDE","trade_name":"ENSACOVE","family_id":"","publication_number":"US8551995B2","cleaned_patent_number":"8551995","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-09","publication_date":"2013-10-08","legal_status":"Granted"} | US8551995B2 Molecular | 08 Oct, 2013 | Granted | 09 Feb, 2029 | |
| {"application_id":"139369","ingredient":"ENSARTINIB HYDROCHLORIDE","trade_name":"ENSACOVE","family_id":"","publication_number":"US9296724B2","cleaned_patent_number":"9296724","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-18","publication_date":"2016-03-29","legal_status":"Patented Case"} | US9296724B2 Molecular | 29 Mar, 2016 | Patented Case | 18 Jun, 2029 | |
| {"application_id":"139370","ingredient":"ENSARTINIB HYDROCHLORIDE","trade_name":"ENSACOVE","family_id":"","publication_number":"US9126947B2","cleaned_patent_number":"9126947","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-29","publication_date":"2015-09-08","legal_status":"Granted"} | US9126947B2 Molecular | 08 Sep, 2015 | Granted | 29 Nov, 2031 | |
| {"application_id":"139368","ingredient":"ENSARTINIB HYDROCHLORIDE","trade_name":"ENSACOVE","family_id":"","publication_number":"US10899744B2","cleaned_patent_number":"10899744","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-01","publication_date":"2021-01-26","legal_status":"Granted"} | US10899744B2 Molecular | 26 Jan, 2021 | Granted | 01 Jun, 2037 |
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.