NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as PROGENICS PHARMS INC. It is marketed under 1 brand name, including PYLARIFY. Available in 1 different strength, such as 50ML (1-80mCi/ML), and administered through 1 route including 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":"74882","ingredient":"PIFLUFOLASTAT F-18","trade_name":"PYLARIFY","family_id":"5f5309712c284f8289ac","publication_number":"US8487129B2","cleaned_patent_number":"8487129","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-07","publication_date":"2013-07-16","legal_status":"Granted"} | US8487129B2 Molecular Formulation | 16 Jul, 2013 | Granted | 07 Nov, 2027 | |
| {"application_id":"74865","ingredient":"PIFLUFOLASTAT F-18","trade_name":"PYLARIFY","family_id":"b81feca7700f44edabd1","publication_number":"US20220088229A1","cleaned_patent_number":"12070513","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-31","publication_date":"2022-03-24","legal_status":"Granted"} | US12070513B2 Molecular Formulation | 24 Mar, 2022 | Granted | 31 Jul, 2029 | |
| {"application_id":"74862","ingredient":"PIFLUFOLASTAT F-18","trade_name":"PYLARIFY","family_id":"b81feca7700f44edabd1","publication_number":"US9861713B2","cleaned_patent_number":"9861713","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-31","publication_date":"2018-01-09","legal_status":"Granted"} | US9861713B2 Molecular Formulation | 09 Jan, 2018 | Granted | 31 Jul, 2029 | |
| {"application_id":"74831","ingredient":"PIFLUFOLASTAT F-18","trade_name":"PYLARIFY","family_id":"b81feca7700f44edabd1","publication_number":"US8778305B2","cleaned_patent_number":"8778305","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-09-21","publication_date":"2014-07-15","legal_status":"Granted"} | US8778305B2 Molecular Formulation | 15 Jul, 2014 | Granted | 21 Sep, 2030 | |
| {"application_id":"74870","ingredient":"PIFLUFOLASTAT F-18","trade_name":"PYLARIFY","family_id":"b71094c73c8f4d56a61a","publication_number":"US10947197B2","cleaned_patent_number":"10947197","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-09","publication_date":"2021-03-16","legal_status":"Patented case"} | US10947197B2 Molecular Formulation | 16 Mar, 2021 | Patented case | 09 Jun, 2037 | |
| {"application_id":"74878","ingredient":"PIFLUFOLASTAT F-18","trade_name":"PYLARIFY","family_id":"b71094c73c8f4d56a61a","publication_number":"US11851407B2","cleaned_patent_number":"11851407","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-09","publication_date":"2023-12-26","legal_status":"Granted"} | US11851407B2 Molecular Formulation | 26 Dec, 2023 | Granted | 09 Jun, 2037 |
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.