NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as AZURITY, BEXIMCO PHARMS USA. It is marketed under 2 brand names, including SOTYLIZE, SOTALOL HYDROCHLORIDE. Available in 4 different strengths, such as 5MG/ML (5MG/ML), 80MG, 120MG and others, and administered through 2 routes including SOLUTION;ORAL, 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":"76864","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTYLIZE","family_id":"3dd157c974844dff92c7","publication_number":"US10206895B2","cleaned_patent_number":"10206895","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-01","publication_date":"2019-02-19","legal_status":"Granted"} | US10206895B2 Formulation | 19 Feb, 2019 | Granted | 01 Apr, 2034 | |
| {"application_id":"184421","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTYLIZE","family_id":"3dd157c974844dff92c7","publication_number":"US12290495B2","cleaned_patent_number":"12290495","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-01","publication_date":"2025-05-06","legal_status":"Granted"} | US12290495B2 | 06 May, 2025 | Granted | 01 Apr, 2034 | |
| {"application_id":"76866","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTYLIZE","family_id":"3dd157c974844dff92c7","publication_number":"US11013703B2","cleaned_patent_number":"11013703","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-01","publication_date":"2021-05-25","legal_status":"Granted"} | US11013703B2 Formulation | 25 May, 2021 | Granted | 01 Apr, 2034 | |
| {"application_id":"76867","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTYLIZE","family_id":"3dd157c974844dff92c7","publication_number":"US11850222B2","cleaned_patent_number":"11850222","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-11-19","publication_date":"2023-12-26","legal_status":"Granted"} | US11850222B2 | 26 Dec, 2023 | Granted | 19 Nov, 2034 | |
| {"application_id":"76865","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTYLIZE","family_id":"3dd157c974844dff92c7","publication_number":"US9724297B2","cleaned_patent_number":"9724297","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-08-31","publication_date":"2017-08-08","legal_status":"Granted"} | US9724297B2 Formulation | 08 Aug, 2017 | Granted | 31 Aug, 2035 | |
| {"application_id":"75013","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTALOL HYDROCHLORIDE","family_id":"fe56008fa0264608a474","publication_number":"US11696902B2","cleaned_patent_number":"11696902","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-14","publication_date":"2023-07-11","legal_status":"Granted"} | US11696902B2 | 11 Jul, 2023 | Granted | 14 Aug, 2038 | |
| {"application_id":"75010","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTALOL HYDROCHLORIDE","family_id":"c262b7cc9cb747ffb3ac","publication_number":"US10512620B1","cleaned_patent_number":"10512620","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-14","publication_date":"2019-12-24","legal_status":"Granted"} | US10512620B2 | 24 Dec, 2019 | Granted | 14 Aug, 2038 | |
| {"application_id":"75021","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTALOL HYDROCHLORIDE","family_id":"0f6f643be3f642baab24","publication_number":"US10799138B2","cleaned_patent_number":"10799138","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-04-05","publication_date":"2020-10-13","legal_status":"Granted"} | US10799138B2 | 13 Oct, 2020 | Granted | 05 Apr, 2039 | |
| {"application_id":"75023","ingredient":"SOTALOL HYDROCHLORIDE","trade_name":"SOTALOL HYDROCHLORIDE","family_id":"61588756fa804b4e810e","publication_number":"US11583216B2","cleaned_patent_number":"11583216","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-21","publication_date":"2023-02-21","legal_status":"Granted"} | US11583216B2 | 21 Feb, 2023 | Granted | 21 Aug, 2039 |
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.