NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as HOFFMANN LA ROCHE. It is marketed under 1 brand name, including ZELBORAF. Available in 1 different strength, such as 240MG, 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":"103547","ingredient":"VEMURAFENIB","trade_name":"ZELBORAF","family_id":"0d7f9c00b037484cb5bc","publication_number":"US8143271B2","cleaned_patent_number":"8143271","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-21","publication_date":"2012-03-27","legal_status":"Expired"} | US8143271B2 Molecular Formulation | 27 Mar, 2012 | Expired | 21 Jun, 2026 | |
| {"application_id":"103478","ingredient":"VEMURAFENIB","trade_name":"ZELBORAF","family_id":"0d7f9c00b037484cb5bc","publication_number":"US8470818B2","cleaned_patent_number":"8470818","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-08-02","publication_date":"2013-06-25","legal_status":"Granted"} | US8470818B2 | 25 Jun, 2013 | Granted | 02 Aug, 2026 | |
| {"application_id":"103651","ingredient":"VEMURAFENIB","trade_name":"ZELBORAF","family_id":"e3fd5205fed341c48884","publication_number":"US7504509B2","cleaned_patent_number":"7504509","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-10-22","publication_date":"2009-03-17","legal_status":"Granted"} | US7504509B2 Molecular Formulation | 17 Mar, 2009 | Granted | 22 Oct, 2026 | |
| {"application_id":"103546","ingredient":"VEMURAFENIB","trade_name":"ZELBORAF","family_id":"0d7f9c00b037484cb5bc","publication_number":"US7863288B2","cleaned_patent_number":"7863288","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-20","publication_date":"2011-01-04","legal_status":"Granted"} | US7863288B2 Molecular Formulation | 04 Jan, 2011 | Granted | 20 Jun, 2029 | |
| {"application_id":"103670","ingredient":"VEMURAFENIB","trade_name":"ZELBORAF","family_id":"1e0720aad5494ef08c70","publication_number":"US8741920B2","cleaned_patent_number":"8741920","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-27","publication_date":"2014-06-03","legal_status":"Granted"} | US8741920B2 Molecular Formulation | 03 Jun, 2014 | Granted | 27 Jul, 2030 | |
| {"application_id":"103572","ingredient":"VEMURAFENIB","trade_name":"ZELBORAF","family_id":"8ccb07f5d7bb44c39b37","publication_number":"US9447089B2","cleaned_patent_number":"9447089","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-06","publication_date":"2016-09-20","legal_status":"Granted"} | US9447089B2 Formulation | 20 Sep, 2016 | Granted | 06 Jun, 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.