NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 15 pharmaceutical companies such as BRISTOL MYERS SQUIBB, MICRO LABS, MYLAN and others. It is marketed under 3 brand names, including ELIQUIS, APIXABAN, ELIQUIS SPRINKLE. Available in 4 different strengths, such as 2.5MG, 5MG, 0.15MG and others, and administered through 3 routes including TABLET;ORAL, FOR SUSPENSION;ORAL, TABLET, FOR 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":"34201","ingredient":"APIXABAN","trade_name":"ELIQUIS","family_id":"12f24e5dcadd4d05bbb3","publication_number":"US6967208B2","cleaned_patent_number":"6967208","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-21","publication_date":"2005-11-22","legal_status":"Expired - Lifetime"} | US6967208B2 | 22 Nov, 2005 | Expired - Lifetime | 21 May, 2027 | |
| {"application_id":"36990","ingredient":"APIXABAN","trade_name":"ELIQUIS","family_id":"dac6fccca4134544ba49","publication_number":"US9326945B2","cleaned_patent_number":"9326945","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-24","publication_date":"2016-05-03","legal_status":"Patented case"} | US9326945B2 | 03 May, 2016 | Patented case | 24 Aug, 2031 | |
| {"application_id":"242103","ingredient":"APIXABAN","trade_name":"ELIQUIS SPRINKLE","family_id":"","publication_number":"US11896586B2","cleaned_patent_number":"11896586","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-05-22","publication_date":"2024-02-13","legal_status":"Granted"} | US11896586B2 | 13 Feb, 2024 | Granted | 22 May, 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.