NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as VERASTEM INC. It is marketed under 1 brand name, including AVMAPKI FAKZYNJA CO-PACK (COPACKAGED). Available in 1 different strength, such as EQ 0.8MG BASE;EQ 200MG BASE, and administered through 1 route including CAPSULE, 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":"242091","ingredient":"AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE","trade_name":"AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)","family_id":"","publication_number":"US7897792B2","cleaned_patent_number":"7897792","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-09","publication_date":"2011-03-01","legal_status":"Granted"} | US7897792B2 Molecular Formulation | 01 Mar, 2011 | Granted | 09 Feb, 2027 | |
| {"application_id":"242090","ingredient":"AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE","trade_name":"AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)","family_id":"","publication_number":"US8247411B2","cleaned_patent_number":"8247411","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-17","publication_date":"2012-08-21","legal_status":"Granted"} | US8247411B2 Molecular Formulation | 21 Aug, 2012 | Granted | 17 Apr, 2028 | |
| {"application_id":"242092","ingredient":"AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE","trade_name":"AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)","family_id":"","publication_number":"US7928109B2","cleaned_patent_number":"7928109","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-21","publication_date":"2011-04-19","legal_status":"Granted"} | US7928109B2 Molecular Formulation | 19 Apr, 2011 | Granted | 21 Aug, 2029 | |
| {"application_id":"242089","ingredient":"AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE","trade_name":"AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)","family_id":"","publication_number":"US11400090B2","cleaned_patent_number":"11400090","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-29","publication_date":"2022-08-02","legal_status":"Granted"} | US11400090B2 | 02 Aug, 2022 | Granted | 29 Oct, 2038 | |
| {"application_id":"242088","ingredient":"AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE","trade_name":"AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)","family_id":"","publication_number":"US11517573B2","cleaned_patent_number":"11517573","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-09-11","publication_date":"2022-12-06","legal_status":"Granted"} | US11517573B2 | 06 Dec, 2022 | Granted | 11 Sep, 2040 | |
| {"application_id":"242087","ingredient":"AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE","trade_name":"AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)","family_id":"","publication_number":"US11873296B2","cleaned_patent_number":"11873296","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-12-29","publication_date":"2024-01-16","legal_status":"Granted"} | US11873296B2 Formulation | 16 Jan, 2024 | Granted | 29 Dec, 2042 |
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.