NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 6 pharmaceutical companies such as CMP DEV LLC, FRESENIUS KABI USA, AM REGENT and others. It is marketed under 2 brand names, including POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE. Available in 10 different strengths, such as 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML), 3.54GM/15ML(236MG/ML); 3.36GM/15ML(224MG/ML), 1.18GM/5ML(236MG/ML); 1.12GM/5ML(224MG/ML) and others, and administered through 1 route including SOLUTION;INTRAVENOUS.
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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 | |
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| {"application_id":"74750","ingredient":"POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC","trade_name":"POTASSIUM PHOSPHATES","family_id":"ba8ae0b47ed04f50bc3f","publication_number":"US10632150B1","cleaned_patent_number":"10632150","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-04-19","publication_date":"2020-04-28","legal_status":"Granted"} | US10632150B2 Formulation | 28 Apr, 2020 | Granted | 19 Apr, 2039 | |
| {"application_id":"242129","ingredient":"POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC","trade_name":"POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE","family_id":"","publication_number":"US11813291B2","cleaned_patent_number":"11813291","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-10-12","publication_date":"2023-11-14","legal_status":"Granted"} | US11813291B2 Formulation | 14 Nov, 2023 | Granted | 12 Oct, 2041 | |
| {"application_id":"242128","ingredient":"POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC","trade_name":"POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE","family_id":"","publication_number":"US11925661B2","cleaned_patent_number":"11925661","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-10-12","publication_date":"2024-03-12","legal_status":"Granted"} | US11925661B2 Formulation | 12 Mar, 2024 | Granted | 12 Oct, 2041 |
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.