NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as INTERCEPT PHARMS INC, LUPIN LTD, APOTEX and others. It is marketed under 2 brand names, including OCALIVA, OBETICHOLIC ACID. Available in 2 different strengths, such as 5MG, 10MG, and administered through 1 route including TABLET;ORAL.
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Licensing: 4 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":"24424","ingredient":"OBETICHOLIC ACID","trade_name":"OCALIVA","family_id":"65e3560c133e4c1ba445","publication_number":"USRE48286E1","cleaned_patent_number":"RE48286","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-21","publication_date":"2020-10-27","legal_status":"Granted"} | USRE48286E1 Molecular Formulation | 27 Oct, 2020 | Granted | 21 Feb, 2027 | |
| {"application_id":"34701","ingredient":"OBETICHOLIC ACID","trade_name":"OCALIVA","family_id":"02c26aed9c8d49049241","publication_number":"US10174073B2","cleaned_patent_number":"10174073","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-17","publication_date":"2019-01-08","legal_status":"Granted"} | US10174073B2 Molecular | 08 Jan, 2019 | Granted | 17 Jun, 2033 | |
| {"application_id":"34703","ingredient":"OBETICHOLIC ACID","trade_name":"OCALIVA","family_id":"60163c455e214396bd7b","publication_number":"US9238673B2","cleaned_patent_number":"9238673","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-17","publication_date":"2016-01-19","legal_status":"Granted"} | US9238673B2 Formulation | 19 Jan, 2016 | Granted | 17 Jun, 2033 | |
| {"application_id":"34705","ingredient":"OBETICHOLIC ACID","trade_name":"OCALIVA","family_id":"02c26aed9c8d49049241","publication_number":"US10047117B2","cleaned_patent_number":"10047117","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-06","publication_date":"2018-08-14","legal_status":"Granted"} | US10047117B2 | 14 Aug, 2018 | Granted | 06 Sep, 2033 | |
| {"application_id":"36358","ingredient":"OBETICHOLIC ACID","trade_name":"OCALIVA","family_id":"ac079ba879da4df38a47","publication_number":"US10751349B2","cleaned_patent_number":"10751349","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-26","publication_date":"2020-08-25","legal_status":"Granted"} | US10751349B2 Formulation | 25 Aug, 2020 | Granted | 26 Apr, 2036 | |
| {"application_id":"36356","ingredient":"OBETICHOLIC ACID","trade_name":"OCALIVA","family_id":"ac079ba879da4df38a47","publication_number":"US10052337B2","cleaned_patent_number":"10052337","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-26","publication_date":"2018-08-21","legal_status":"Granted"} | US10052337B2 Formulation | 21 Aug, 2018 | Granted | 26 Apr, 2036 | |
| {"application_id":"36359","ingredient":"OBETICHOLIC ACID","trade_name":"OCALIVA","family_id":"ac079ba879da4df38a47","publication_number":"US10758549B2","cleaned_patent_number":"10758549","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-26","publication_date":"2020-09-01","legal_status":"Granted"} | US10758549B2 | 01 Sep, 2020 | Granted | 26 Apr, 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.