NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 6 pharmaceutical companies such as MYLAN, TEVA PHARMS USA INC, DR REDDYS and others. It is marketed under 1 brand name, including SORAFENIB TOSYLATE. Available in 1 different strength, such as EQ 200MG BASE, 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":"96794","ingredient":"SORAFENIB TOSYLATE","trade_name":"NEXAVAR","family_id":"be0b92c3a4bc42a5b27e","publication_number":"US8877933B2","cleaned_patent_number":"8877933","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-24","publication_date":"2014-11-04","legal_status":"Granted"} | US8877933B2 Molecular Formulation | 04 Nov, 2014 | Granted | 24 Dec, 2027 | |
| {"application_id":"96834","ingredient":"SORAFENIB TOSYLATE","trade_name":"NEXAVAR","family_id":"5353692686104a5b8fc4","publication_number":"US9737488B2","cleaned_patent_number":"9737488","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-10","publication_date":"2017-08-22","legal_status":"Granted"} | US9737488B2 Formulation | 22 Aug, 2017 | Granted | 10 Sep, 2028 |
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.