NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as TAKEDA PHARMS USA, ZYDUS PHARMS. It is marketed under 2 brand names, including TRINTELLIX, VORTIOXETINE HYDROBROMIDE. Available in 4 different strengths, such as EQ 5MG BASE, EQ 10MG BASE, EQ 15MG BASE and others, and administered through 1 route including TABLET;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":"36202","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8cad016789e8484a921f","publication_number":"US7144884B2","cleaned_patent_number":"7144884","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-17","publication_date":"2006-12-05","legal_status":"Expired"} | US7144884B2 | 05 Dec, 2006 | Expired | 17 Dec, 2026 | |
| {"application_id":"34697","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US9861630B2","cleaned_patent_number":"9861630","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-15","publication_date":"2018-01-09","legal_status":"Granted"} | US9861630B2 | 09 Jan, 2018 | Granted | 15 Dec, 2027 | |
| {"application_id":"1520","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US9227946B2","cleaned_patent_number":"9227946","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-15","publication_date":"2016-01-05","legal_status":"Granted"} | US9227946B2 | 05 Jan, 2016 | Granted | 15 Dec, 2027 | |
| {"application_id":"34700","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US11458134B2","cleaned_patent_number":"11458134","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-15","publication_date":"2022-10-04","legal_status":"Granted"} | US11458134B2 | 04 Oct, 2022 | Granted | 15 Dec, 2027 | |
| {"application_id":"1512","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US8969355B2","cleaned_patent_number":"8969355","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-15","publication_date":"2015-03-03","legal_status":"Granted"} | US8969355B2 | 03 Mar, 2015 | Granted | 15 Dec, 2027 | |
| {"application_id":"34689","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US9125908B2","cleaned_patent_number":"9125908","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-15","publication_date":"2015-09-08","legal_status":"Granted"} | US9125908B2 | 08 Sep, 2015 | Granted | 15 Dec, 2027 | |
| {"application_id":"34690","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US9125909B2","cleaned_patent_number":"9125909","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-15","publication_date":"2015-09-08","legal_status":"Granted"} | US9125909B2 | 08 Sep, 2015 | Granted | 15 Dec, 2027 | |
| {"application_id":"1519","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US9125910B2","cleaned_patent_number":"9125910","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-15","publication_date":"2015-09-08","legal_status":"Granted"} | US9125910B2 | 08 Sep, 2015 | Granted | 15 Dec, 2027 | |
| {"application_id":"34691","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"8bc202ae06fb47eb85c5","publication_number":"US8722684B2","cleaned_patent_number":"8722684","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-12-30","publication_date":"2014-05-13","legal_status":"Granted"} | US8722684B2 | 13 May, 2014 | Granted | 30 Dec, 2031 | |
| {"application_id":"36342","ingredient":"VORTIOXETINE HYDROBROMIDE","trade_name":"TRINTELLIX","family_id":"5be549d733874bb09390","publication_number":"US9278096B2","cleaned_patent_number":"9278096","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-21","publication_date":"2016-03-08","legal_status":"Granted"} | US9278096B2 | 08 Mar, 2016 | Granted | 21 Sep, 2032 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.