NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 10 pharmaceutical companies such as BOEHRINGER INGELHEIM, ALKEM LABS LTD, HETERO LABS LTD III and others. It is marketed under 2 brand names, including PRADAXA, DABIGATRAN ETEXILATE MESYLATE. Available in 9 different strengths, such as EQ 150MG BASE, EQ 75MG BASE, EQ 110MG BASE and others, and administered through 2 routes including CAPSULE;ORAL, PELLETS;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":"25605","ingredient":"DABIGATRAN ETEXILATE MESYLATE","trade_name":"PRADAXA","family_id":"9f76331f56d54a319571","publication_number":"US7932273B2","cleaned_patent_number":"7932273","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-07","publication_date":"2011-04-26","legal_status":"Granted"} | US7932273B2 | 26 Apr, 2011 | Granted | 07 Mar, 2026 | |
| {"application_id":"39713","ingredient":"DABIGATRAN ETEXILATE MESYLATE","trade_name":"PRADAXA","family_id":"0ba86878ad9b4776b0e2","publication_number":"US9034822B2","cleaned_patent_number":"9034822","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-07-20","publication_date":"2015-05-19","legal_status":"Granted"} | US9034822B2 | 19 May, 2015 | Granted | 20 Jul, 2031 |
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.