NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 26 pharmaceutical companies such as AM REGENT, MYLAN INSTITUTIONAL, EPIC PHARMA LLC and others. It is marketed under 1 brand name, including TRANEXAMIC ACID. Available in 3 different strengths, such as 100MG/ML, 650MG, 1GM/100ML (10MG/ML), and administered through 3 routes including INJECTABLE;INJECTION, TABLET;ORAL, 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 | |
|---|---|---|---|---|---|
| {"application_id":"96118","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US7947739B2","cleaned_patent_number":"7947739","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2011-05-24","legal_status":"Granted"} | US7947739B2 Formulation | 24 May, 2011 | Granted | 04 Mar, 2025 | |
| {"application_id":"96113","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US8022106B2","cleaned_patent_number":"8022106","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2011-09-20","legal_status":"Patented case"} | US8022106B2 | 20 Sep, 2011 | Patented case | 04 Mar, 2025 | |
| {"application_id":"96119","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US8273795B2","cleaned_patent_number":"8273795","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2012-09-25","legal_status":"Granted"} | US8273795B2 | 25 Sep, 2012 | Granted | 04 Mar, 2025 | |
| {"application_id":"96120","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US8487005B2","cleaned_patent_number":"8487005","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2013-07-16","legal_status":"Granted"} | US8487005B2 Formulation | 16 Jul, 2013 | Granted | 04 Mar, 2025 | |
| {"application_id":"96121","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US8791160B2","cleaned_patent_number":"8791160","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2014-07-29","legal_status":"Granted"} | US8791160B2 Formulation | 29 Jul, 2014 | Granted | 04 Mar, 2025 | |
| {"application_id":"96122","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US8809394B2","cleaned_patent_number":"8809394","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2014-08-19","legal_status":"Granted"} | US8809394B2 Formulation | 19 Aug, 2014 | Granted | 04 Mar, 2025 | |
| {"application_id":"96123","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US8957113B2","cleaned_patent_number":"8957113","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2015-02-17","legal_status":"Granted"} | US8957113B2 Formulation | 17 Feb, 2015 | Granted | 04 Mar, 2025 | |
| {"application_id":"96124","ingredient":"TRANEXAMIC ACID","trade_name":"LYSTEDA","family_id":"e6b98cf88d8144f487e9","publication_number":"US9060939B2","cleaned_patent_number":"9060939","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-04","publication_date":"2015-06-23","legal_status":"Granted"} | US9060939B2 Formulation | 23 Jun, 2015 | Granted | 04 Mar, 2025 |
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.