NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 20 pharmaceutical companies such as FRESENIUS KABI USA, ENDO OPERATIONS, PIRAMAL CRITICAL and others. It is marketed under 5 brand names, including LEVOTHYROXINE SODIUM, TIROSINT-SOL, TIROSINT and others. Available in 38 different strengths, such as 500MCG/VIAL, 200MCG/VIAL, 100MCG/VIAL and others, and administered through 5 routes including POWDER;INTRAVENOUS, SOLUTION;ORAL, CAPSULE;ORAL and others.
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Licensing: 20 potential partnersUS Launch window: Loading launch window...
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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":"76909","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"THYQUIDITY","family_id":"fbf63231f32f498683d5","publication_number":"US9050307B2","cleaned_patent_number":"9050307","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-06","publication_date":"2015-06-09","legal_status":"Granted"} | US9050307B2 Formulation | 09 Jun, 2015 | Granted | 06 Aug, 2031 | |
| {"application_id":"67304","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOTHYROXINE SODIUM","family_id":"47f2c118babe4fb98c41","publication_number":"US9168239B2","cleaned_patent_number":"9168239","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-29","publication_date":"2015-10-27","legal_status":"Granted"} | US9168239B2 Formulation | 27 Oct, 2015 | Granted | 29 Aug, 2032 | |
| {"application_id":"67307","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOTHYROXINE SODIUM","family_id":"47f2c118babe4fb98c41","publication_number":"US9168238B2","cleaned_patent_number":"9168238","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-29","publication_date":"2015-10-27","legal_status":"Granted"} | US9168238B2 Formulation | 27 Oct, 2015 | Granted | 29 Aug, 2032 | |
| {"application_id":"67306","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOTHYROXINE SODIUM","family_id":"47f2c118babe4fb98c41","publication_number":"US9006289B2","cleaned_patent_number":"9006289","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-10-03","publication_date":"2015-04-14","legal_status":"Granted"} | US9006289B2 Formulation | 14 Apr, 2015 | Granted | 03 Oct, 2032 | |
| {"application_id":"76330","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"ERMEZA","family_id":"a2672e9072934e05a399","publication_number":"US9345772B1","cleaned_patent_number":"9345772","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-27","publication_date":"2016-05-24","legal_status":"Granted"} | US9345772B2 Formulation | 24 May, 2016 | Granted | 27 Feb, 2035 | |
| {"application_id":"73945","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOTHYROXINE SODIUM","family_id":"3139ae05e46d4dce9587","publication_number":"US11154498B2","cleaned_patent_number":"11154498","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-07-20","publication_date":"2021-10-26","legal_status":"Granted"} | US11154498B2 Formulation | 26 Oct, 2021 | Granted | 20 Jul, 2036 | |
| {"application_id":"73953","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOTHYROXINE SODIUM","family_id":"5bd6226da0434d8a9b04","publication_number":"US10398669B2","cleaned_patent_number":"10398669","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-01","publication_date":"2019-09-03","legal_status":"Granted"} | US10398669B2 Formulation | 03 Sep, 2019 | Granted | 01 Dec, 2036 | |
| {"application_id":"73950","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOTHYROXINE SODIUM","family_id":"5bd6226da0434d8a9b04","publication_number":"US11135190B2","cleaned_patent_number":"11135190","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-01","publication_date":"2021-10-05","legal_status":"Granted"} | US11135190B2 Formulation | 05 Oct, 2021 | Granted | 01 Dec, 2036 | |
| {"application_id":"73952","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOTHYROXINE SODIUM","family_id":"5bd6226da0434d8a9b04","publication_number":"US9782376B1","cleaned_patent_number":"9782376","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-01","publication_date":"2017-10-10","legal_status":"Granted"} | US9782376B2 Formulation | 10 Oct, 2017 | Granted | 01 Dec, 2036 | |
| {"application_id":"76921","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"TIROSINT-SOL","family_id":"c77ba1b369ab4915b3f3","publication_number":"US11096913B2","cleaned_patent_number":"11096913","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-28","publication_date":"2021-08-24","legal_status":"Granted"} | US11096913B2 Formulation | 24 Aug, 2021 | Granted | 28 Feb, 2037 | |
| {"application_id":"76933","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"TIROSINT-SOL","family_id":"c77ba1b369ab4915b3f3","publication_number":"US10537538B2","cleaned_patent_number":"10537538","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-28","publication_date":"2020-01-21","legal_status":"Granted"} | US10537538B2 Formulation | 21 Jan, 2020 | Granted | 28 Feb, 2037 | |
| {"application_id":"95728","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOLET","family_id":"9ff5876a6e8c4fafa59c","publication_number":"US10231931B1","cleaned_patent_number":"10231931","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-03-23","publication_date":"2019-03-19","legal_status":"Granted"} | US10231931B2 Formulation | 19 Mar, 2019 | Granted | 23 Mar, 2038 | |
| {"application_id":"95727","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"LEVOLET","family_id":"9ff5876a6e8c4fafa59c","publication_number":"US10406108B1","cleaned_patent_number":"10406108","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-03-23","publication_date":"2019-09-10","legal_status":"Granted"} | US10406108B2 Formulation | 10 Sep, 2019 | Granted | 23 Mar, 2038 | |
| {"application_id":"120883","ingredient":"LEVOTHYROXINE SODIUM","trade_name":"TIROSINT-SOL","family_id":"d5703ae6dbba44508bf7","publication_number":"US11241382B2","cleaned_patent_number":"11241382","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-09-17","publication_date":"2022-02-08","legal_status":"Granted"} | US11241382B2 | 08 Feb, 2022 | Granted | 17 Sep, 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.