Pexidartinib Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as DAIICHI SANKYO INC. It is marketed under 1 brand name, including TURALIO. Available in 2 different strengths, such as EQ 200MG BASE, EQ 125MG BASE, and administered through 1 route including CAPSULE;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":"51836","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"0559ee32a5d64adbbac3","publication_number":"US8404700B2","cleaned_patent_number":"8404700","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-21","publication_date":"2013-03-26","legal_status":"Granted"} US8404700B2 Molecular 26 Mar, 2013 Granted 21 Nov, 2027
{"application_id":"51838","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"0559ee32a5d64adbbac3","publication_number":"US9169250B2","cleaned_patent_number":"9169250","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-21","publication_date":"2015-10-27","legal_status":"Granted"} US9169250B2 Molecular 27 Oct, 2015 Granted 21 Nov, 2027
{"application_id":"51837","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"0559ee32a5d64adbbac3","publication_number":"US8722702B2","cleaned_patent_number":"8722702","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-21","publication_date":"2014-05-13","legal_status":"Granted"} US8722702B2 Molecular 13 May, 2014 Granted 21 Nov, 2027
{"application_id":"51798","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"0559ee32a5d64adbbac3","publication_number":"US8461169B2","cleaned_patent_number":"8461169","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-19","publication_date":"2013-06-11","legal_status":"Granted"} US8461169B2 11 Jun, 2013 Granted 19 Apr, 2028
{"application_id":"51835","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"0559ee32a5d64adbbac3","publication_number":"US7893075B2","cleaned_patent_number":"7893075","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-04","publication_date":"2011-02-22","legal_status":"Granted"} US7893075B2 Molecular 22 Feb, 2011 Granted 04 May, 2033
{"application_id":"122083","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"f6d6e5dd2e5e48038912","publication_number":"US9358235B2","cleaned_patent_number":"9358235","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-08","publication_date":"2016-06-07","legal_status":"Granted"} US9358235B2 07 Jun, 2016 Granted 08 Jun, 2033
{"application_id":"51889","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"685eedb0290747279156","publication_number":"US9802932B2","cleaned_patent_number":"9802932","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-05","publication_date":"2017-10-31","legal_status":"Granted"} US9802932B2 Molecular 31 Oct, 2017 Granted 05 May, 2036
{"application_id":"51893","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"685eedb0290747279156","publication_number":"US10730876B2","cleaned_patent_number":"10730876","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-05","publication_date":"2020-08-04","legal_status":"Granted"} US10730876B2 Molecular 04 Aug, 2020 Granted 05 May, 2036
{"application_id":"51849","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"685eedb0290747279156","publication_number":"US10189833B2","cleaned_patent_number":"10189833","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-05","publication_date":"2019-01-29","legal_status":"Granted"} US10189833B2 29 Jan, 2019 Granted 05 May, 2036
{"application_id":"122050","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"384338dbe7b049b8b7f9","publication_number":"US10941142B2","cleaned_patent_number":"10941142","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-24","publication_date":"2021-03-09","legal_status":"Granted"} US10941142B2 Formulation 09 Mar, 2021 Granted 24 Jul, 2038
{"application_id":"51912","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"384338dbe7b049b8b7f9","publication_number":"US10435404B2","cleaned_patent_number":"10435404","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-24","publication_date":"2019-10-08","legal_status":"Granted"} US10435404B2 Formulation 08 Oct, 2019 Granted 24 Jul, 2038
{"application_id":"51903","ingredient":"PEXIDARTINIB HYDROCHLORIDE","trade_name":"TURALIO","family_id":"384338dbe7b049b8b7f9","publication_number":"US10961240B2","cleaned_patent_number":"10961240","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-24","publication_date":"2021-03-30","legal_status":"Granted"} US10961240B2 30 Mar, 2021 Granted 24 Jul, 2038

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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.

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