NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as SECURA. It is marketed under 1 brand name, including COPIKTRA. Available in 2 different strengths, such as 15MG, 25MG, and administered through 1 route including CAPSULE;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":"1761","ingredient":"DUVELISIB","trade_name":"COPIKTRA","family_id":"714014f8f4294e24b24c","publication_number":"US9216982B2","cleaned_patent_number":"9216982","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-01-05","publication_date":"2015-12-22","legal_status":"Granted"} | US9216982B2 | 22 Dec, 2015 | Granted | 05 Jan, 2029 | |
| {"application_id":"1760","ingredient":"DUVELISIB","trade_name":"COPIKTRA","family_id":"714014f8f4294e24b24c","publication_number":"US8193182B2","cleaned_patent_number":"8193182","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-13","publication_date":"2012-06-05","legal_status":"Granted"} | US8193182B2 Molecular | 05 Jun, 2012 | Granted | 13 Feb, 2030 | |
| {"application_id":"1767","ingredient":"DUVELISIB","trade_name":"COPIKTRA","family_id":"079e5b6057a64c0d9b8d","publication_number":"US11312718B2","cleaned_patent_number":"11312718","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-10","publication_date":"2022-04-26","legal_status":"Granted"} | US11312718B2 Formulation | 26 Apr, 2022 | Granted | 10 Jan, 2032 | |
| {"application_id":"1762","ingredient":"DUVELISIB","trade_name":"COPIKTRA","family_id":"079e5b6057a64c0d9b8d","publication_number":"US9840505B2","cleaned_patent_number":"9840505","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-10","publication_date":"2017-12-12","legal_status":"Granted"} | US9840505B2 | 12 Dec, 2017 | Granted | 10 Jan, 2032 | |
| {"application_id":"21919","ingredient":"DUVELISIB","trade_name":"COPIKTRA","family_id":"079e5b6057a64c0d9b8d","publication_number":"USRE46621E","cleaned_patent_number":"RE46621","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-17","publication_date":"2017-12-05","legal_status":"Granted"} | USRE46621E1 Molecular Formulation | 05 Dec, 2017 | Granted | 17 May, 2032 | |
| {"application_id":"2635","ingredient":"DUVELISIB","trade_name":"COPIKTRA","family_id":"4de8b66391c34d368da4","publication_number":"US20210060022A1","cleaned_patent_number":"12213983","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-26","publication_date":"2025-02-04","legal_status":"Pending"} | US12213983B2 | 04 Feb, 2025 | Pending | 26 Apr, 2035 |
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.