NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 9 pharmaceutical companies such as AMNEAL PHARMS, AUROBINDO PHARMA, JUBILANT GENERICS and others. It is marketed under 2 brand names, including SPIRONOLACTONE, CAROSPIR. Available in 4 different strengths, such as 25MG, 100MG, 50MG and others, and administered through 2 routes including TABLET;ORAL, SUSPENSION;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":"82828","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"e3cb5c7d1de742fc8b59","publication_number":"US10493083B2","cleaned_patent_number":"10493083","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2019-12-03","legal_status":"Granted"} | US10493083B2 Formulation | 03 Dec, 2019 | Granted | 28 Oct, 2036 | |
| {"application_id":"82841","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"","publication_number":"US10624906B1","cleaned_patent_number":"10624906","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2020-04-21","legal_status":"Granted"} | US10624906B2 Formulation | 21 Apr, 2020 | Granted | 28 Oct, 2036 | |
| {"application_id":"82834","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"e3cb5c7d1de742fc8b59","publication_number":"US10660907B1","cleaned_patent_number":"10660907","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2020-05-26","legal_status":"Granted"} | US10660907B2 Formulation | 26 May, 2020 | Granted | 28 Oct, 2036 | |
| {"application_id":"82835","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"e3cb5c7d1de742fc8b59","publication_number":"US10888570B2","cleaned_patent_number":"10888570","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2021-01-12","legal_status":"Granted"} | US10888570B2 Formulation | 12 Jan, 2021 | Granted | 28 Oct, 2036 | |
| {"application_id":"82836","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"e3cb5c7d1de742fc8b59","publication_number":"US11389461B2","cleaned_patent_number":"11389461","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2022-07-19","legal_status":"Granted"} | US11389461B2 Formulation | 19 Jul, 2022 | Granted | 28 Oct, 2036 | |
| {"application_id":"82837","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"e3cb5c7d1de742fc8b59","publication_number":"US11395828B2","cleaned_patent_number":"11395828","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2022-07-26","legal_status":"Granted"} | US11395828B2 | 26 Jul, 2022 | Granted | 28 Oct, 2036 | |
| {"application_id":"82838","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"ba442c9d92f74552ad1b","publication_number":"US11491166B2","cleaned_patent_number":"11491166","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2022-11-08","legal_status":"Granted"} | US11491166B2 Formulation | 08 Nov, 2022 | Granted | 28 Oct, 2036 | |
| {"application_id":"82832","ingredient":"SPIRONOLACTONE","trade_name":"CAROSPIR","family_id":"e3cb5c7d1de742fc8b59","publication_number":"US9757394B2","cleaned_patent_number":"9757394","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2017-09-12","legal_status":"Granted"} | US9757394B2 Formulation | 12 Sep, 2017 | Granted | 28 Oct, 2036 |
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.