NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 3 pharmaceutical companies such as TAIHO ONCOLOGY, NATCO, MSN. It is marketed under 2 brand names, including LONSURF, TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE. Available in 2 different strengths, such as EQ 6.14MG BASE;15MG, EQ 8.19MG BASE;20MG, and administered through 1 route including TABLET;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 |
|---|
Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"95927","ingredient":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trade_name":"LONSURF","family_id":"4b6c539f93a846e596f3","publication_number":"USRE46284E1","cleaned_patent_number":"RE46284","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-22","publication_date":"2017-01-24","legal_status":"Patented case"} | USRE46284E1 | 24 Jan, 2017 | Patented case | 22 Sep, 2029 | |
| {"application_id":"2806","ingredient":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trade_name":"LONSURF","family_id":"08c16383fec449298e00","publication_number":"US10457666B2","cleaned_patent_number":"10457666","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-17","publication_date":"2019-10-29","legal_status":"Patented case"} | US10457666B2 Molecular Formulation | 29 Oct, 2019 | Patented case | 17 Jun, 2034 | |
| {"application_id":"2786","ingredient":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trade_name":"LONSURF","family_id":"08c16383fec449298e00","publication_number":"US9527833B2","cleaned_patent_number":"9527833","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-17","publication_date":"2016-12-27","legal_status":"Expired"} | US9527833B2 Molecular Formulation | 27 Dec, 2016 | Expired | 17 Jun, 2034 | |
| {"application_id":"116619","ingredient":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trade_name":"LONSURF","family_id":"c2bfca045fd6404e9723","publication_number":"US9943537B2","cleaned_patent_number":"9943537","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-09-05","publication_date":"2018-04-17","legal_status":"Granted"} | US9943537B2 | 17 Apr, 2018 | Granted | 05 Sep, 2034 | |
| {"application_id":"95928","ingredient":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trade_name":"LONSURF","family_id":"0fd077b30b4e4df88adf","publication_number":"US10456399B2","cleaned_patent_number":"10456399","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-03","publication_date":"2019-10-29","legal_status":"Granted"} | US10456399B2 | 29 Oct, 2019 | Granted | 03 Feb, 2037 | |
| {"application_id":"95940","ingredient":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trade_name":"LONSURF","family_id":"0fd077b30b4e4df88adf","publication_number":"US10960004B2","cleaned_patent_number":"10960004","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-03","publication_date":"2021-03-30","legal_status":"Granted"} | US10960004B2 | 30 Mar, 2021 | Granted | 03 Feb, 2037 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.