NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as BAYER HLTHCARE, ACTAVIS LABS FL. It is marketed under 2 brand names, including STIVARGA, REGORAFENIB. Available in 1 different strength, such as 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":"99532","ingredient":"REGORAFENIB","trade_name":"STIVARGA","family_id":"6a5b4dabb4394191b56e","publication_number":"US8680124B2","cleaned_patent_number":"8680124","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-02","publication_date":"2014-03-25","legal_status":"Granted"} | US8680124B2 | 25 Mar, 2014 | Granted | 02 Jun, 2030 | |
| {"application_id":"99732","ingredient":"REGORAFENIB","trade_name":"STIVARGA","family_id":"5c60f49f3e4646a592e7","publication_number":"US8637553B2","cleaned_patent_number":"8637553","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-16","publication_date":"2014-01-28","legal_status":"Granted"} | US8637553B2 Molecular Formulation | 28 Jan, 2014 | Granted | 16 Feb, 2031 | |
| {"application_id":"99543","ingredient":"REGORAFENIB","trade_name":"STIVARGA","family_id":"d667cdaf912749359a78","publication_number":"US9458107B2","cleaned_patent_number":"9458107","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-08","publication_date":"2016-10-04","legal_status":"Granted"} | US9458107B2 Formulation | 04 Oct, 2016 | Granted | 08 Apr, 2031 | |
| {"application_id":"99796","ingredient":"REGORAFENIB","trade_name":"STIVARGA","family_id":"9ed7ffd71977430a8bbb","publication_number":"US9957232B2","cleaned_patent_number":"9957232","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-09","publication_date":"2018-05-01","legal_status":"Granted"} | US9957232B2 Molecular | 01 May, 2018 | Granted | 09 Jul, 2032 |
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.