NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as FERRING PHARMS INC, HETERO LABS LTD V. It is marketed under 3 brand names, including PREPOPIK, CLENPIQ, SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID. Available in 2 different strengths, such as 12GM/PACKET;3.5GM/PACKET;10MG/PACKET, 12GM/BOT;3.5GM/BOT;10MG/BOT, and administered through 2 routes including FOR SOLUTION;ORAL, SOLUTION;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":"57367","ingredient":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","trade_name":"PREPOPIK","family_id":"78be14261d6e49a7b00b","publication_number":"US8450338B2","cleaned_patent_number":"8450338","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-10","publication_date":"2013-05-28","legal_status":"Granted"} | US8450338B2 Formulation | 28 May, 2013 | Granted | 10 Oct, 2028 | |
| {"application_id":"57341","ingredient":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","trade_name":"PREPOPIK","family_id":"78be14261d6e49a7b00b","publication_number":"US8481083B2","cleaned_patent_number":"8481083","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-10","publication_date":"2013-07-09","legal_status":"Granted"} | US8481083B2 Formulation | 09 Jul, 2013 | Granted | 10 Oct, 2028 | |
| {"application_id":"76027","ingredient":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","trade_name":"CLENPIQ","family_id":"d9210d9f77854a9caee2","publication_number":"US10624879B2","cleaned_patent_number":"10624879","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-23","publication_date":"2020-04-21","legal_status":"Granted"} | US10624879B2 Formulation | 21 Apr, 2020 | Granted | 23 Jun, 2034 | |
| {"application_id":"76028","ingredient":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","trade_name":"CLENPIQ","family_id":"d9210d9f77854a9caee2","publication_number":"US11191753B2","cleaned_patent_number":"11191753","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-23","publication_date":"2021-12-07","legal_status":"Granted"} | US11191753B2 | 07 Dec, 2021 | Granted | 23 Jun, 2034 | |
| {"application_id":"76017","ingredient":"CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE","trade_name":"CLENPIQ","family_id":"d9210d9f77854a9caee2","publication_number":"US9827231B2","cleaned_patent_number":"9827231","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-26","publication_date":"2017-11-28","legal_status":"Granted"} | US9827231B2 Formulation | 28 Nov, 2017 | Granted | 26 Jun, 2034 |
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.