NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as SERVIER. It is marketed under 1 brand name, including VORANIGO. Available in 2 different strengths, such as 10MG, 40MG, 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 |
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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":"130746","ingredient":"VORASIDENIB","trade_name":"VORANIGO","family_id":"b94b3f062f3040b38cab","publication_number":"US10172864B2","cleaned_patent_number":"10172864","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-11","publication_date":"2019-01-08","legal_status":"Granted"} | US10172864B2 Molecular Formulation | 08 Jan, 2019 | Granted | 11 Jul, 2034 | |
| {"application_id":"130745","ingredient":"VORASIDENIB","trade_name":"VORANIGO","family_id":"b94b3f062f3040b38cab","publication_number":"US9579324B2","cleaned_patent_number":"9579324","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-11","publication_date":"2017-02-28","legal_status":"Granted"} | US9579324B2 Molecular | 28 Feb, 2017 | Granted | 11 Jul, 2034 | |
| {"application_id":"130744","ingredient":"VORASIDENIB","trade_name":"VORANIGO","family_id":"b94b3f062f3040b38cab","publication_number":"US11844758B2","cleaned_patent_number":"11844758","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-12-04","publication_date":"2023-12-19","legal_status":"Patented case"} | US11844758B2 | 19 Dec, 2023 | Patented case | 04 Dec, 2035 | |
| {"application_id":"18750","ingredient":"VORASIDENIB","trade_name":"VORANIGO","family_id":"1142bb2cbe084dcdbe84","publication_number":"US11345677B2","cleaned_patent_number":"11345677","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-16","publication_date":"2022-05-31","legal_status":"Granted"} | US11345677B2 Molecular Formulation | 31 May, 2022 | Granted | 16 Jan, 2039 |
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.