Tepotinib Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as EMD SERONO INC. It is marketed under 1 brand name, including TEPMETKO. Available in 1 different strength, such as EQ 225MG BASE, and administered through 1 route including TABLET;ORAL.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"101088","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US9284300B2","cleaned_patent_number":"9284300","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-29","publication_date":"2016-03-15","legal_status":"Granted"} US9284300B2 Formulation 15 Mar, 2016 Granted 29 Apr, 2028
{"application_id":"101085","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US8921357B2","cleaned_patent_number":"8921357","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-05-30","publication_date":"2014-12-30","legal_status":"Granted"} US8921357B2 Molecular Formulation 30 Dec, 2014 Granted 30 May, 2028
{"application_id":"101087","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US9062029B2","cleaned_patent_number":"9062029","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-04","publication_date":"2015-06-23","legal_status":"Granted"} US9062029B2 Formulation 23 Jun, 2015 Granted 04 Jul, 2028
{"application_id":"101089","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US9403799B2","cleaned_patent_number":"9403799","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-04","publication_date":"2016-08-02","legal_status":"Granted"} US9403799B2 02 Aug, 2016 Granted 04 Jul, 2028
{"application_id":"101018","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US8658643B2","cleaned_patent_number":"8658643","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-04","publication_date":"2014-02-25","legal_status":"Granted"} US8658643B2 25 Feb, 2014 Granted 04 Jul, 2028
{"application_id":"101086","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US8927540B2","cleaned_patent_number":"8927540","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-21","publication_date":"2015-01-06","legal_status":"Granted"} US8927540B2 06 Jan, 2015 Granted 21 Jul, 2028
{"application_id":"101083","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US8329692B2","cleaned_patent_number":"8329692","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-30","publication_date":"2012-12-11","legal_status":"Granted"} US8329692B2 Molecular Formulation 11 Dec, 2012 Granted 30 Oct, 2029
{"application_id":"101084","ingredient":"TEPOTINIB HYDROCHLORIDE","trade_name":"TEPMETKO","family_id":"a3cba408dcff427e9141","publication_number":"US8580781B2","cleaned_patent_number":"8580781","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-19","publication_date":"2013-11-12","legal_status":"Granted"} US8580781B2 Molecular Formulation 12 Nov, 2013 Granted 19 Mar, 2030

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID Title Status Phase Conditions Start Date Completion Date

API Suppliers/Manufacturer (Branded/Generic companies)

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.