Dexmedetomidine Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 27 pharmaceutical companies such as HOSPIRA, ENDO OPERATIONS, MYLAN INSTITUTIONAL and others. It is marketed under 3 brand names, including PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, IGALMI. Available in 9 different strengths, such as EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) and others, and administered through 3 routes including INJECTABLE;INJECTION, SOLUTION;INTRAVENOUS, FILM;BUCCAL, SUBLINGUAL.

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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":"61951","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"PRECEDEX","family_id":"e5888df8bc864b099d56","publication_number":"US10016396B2","cleaned_patent_number":"10016396","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-04","publication_date":"2018-07-10","legal_status":"Granted"} US10016396B2 Formulation 10 Jul, 2018 Granted 04 Jan, 2032
{"application_id":"61999","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"PRECEDEX","family_id":"e5888df8bc864b099d56","publication_number":"US9616049B2","cleaned_patent_number":"9616049","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-04","publication_date":"2017-04-11","legal_status":"Patented case"} US9616049B2 11 Apr, 2017 Patented case 04 Jul, 2032
{"application_id":"61993","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"PRECEDEX","family_id":"e5888df8bc864b099d56","publication_number":"US8242158B1","cleaned_patent_number":"8242158","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-04","publication_date":"2012-08-14","legal_status":"Granted"} US8242158B2 14 Aug, 2012 Granted 04 Jul, 2032
{"application_id":"61997","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"PRECEDEX","family_id":"e5888df8bc864b099d56","publication_number":"US8648106B2","cleaned_patent_number":"8648106","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-04","publication_date":"2014-02-11","legal_status":"Patented case"} US8648106B2 11 Feb, 2014 Patented case 04 Jul, 2032
{"application_id":"61996","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"PRECEDEX","family_id":"e5888df8bc864b099d56","publication_number":"US8455527B1","cleaned_patent_number":"8455527","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-04","publication_date":"2013-06-04","legal_status":"Granted"} US8455527B2 04 Jun, 2013 Granted 04 Jul, 2032
{"application_id":"61994","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"PRECEDEX","family_id":"e5888df8bc864b099d56","publication_number":"US8338470B1","cleaned_patent_number":"8338470","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-04","publication_date":"2012-12-25","legal_status":"Patented case"} US8338470B2 25 Dec, 2012 Patented case 04 Jul, 2032
{"application_id":"61998","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"PRECEDEX","family_id":"e5888df8bc864b099d56","publication_number":"US9320712B2","cleaned_patent_number":"9320712","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-04","publication_date":"2016-04-26","legal_status":"Granted"} US9320712B2 26 Apr, 2016 Granted 04 Jul, 2032
{"application_id":"73505","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"DEXMEDETOMIDINE HYDROCHLORIDE","family_id":"af27e5d986da4979a3cd","publication_number":"US9717796B1","cleaned_patent_number":"9717796","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-20","publication_date":"2017-08-01","legal_status":"Granted"} US9717796B2 Formulation 01 Aug, 2017 Granted 20 Apr, 2036
{"application_id":"73501","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"DEXMEDETOMIDINE HYDROCHLORIDE","family_id":"af27e5d986da4979a3cd","publication_number":"US9649296B1","cleaned_patent_number":"9649296","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-20","publication_date":"2017-05-16","legal_status":"Granted"} US9649296B2 Formulation 16 May, 2017 Granted 20 Apr, 2036
{"application_id":"117230","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"bf265bd1b1aa48439f80","publication_number":"US11786508B2","cleaned_patent_number":"11786508","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-29","publication_date":"2023-10-17","legal_status":"Granted"} US11786508B2 17 Oct, 2023 Granted 29 Dec, 2037
{"application_id":"117249","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"bf265bd1b1aa48439f80","publication_number":"US11839604B2","cleaned_patent_number":"11839604","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-29","publication_date":"2023-12-12","legal_status":"Patented case"} US11839604B2 12 Dec, 2023 Patented case 29 Dec, 2037
{"application_id":"56428","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"dc6cdcc572594c6895be","publication_number":"US10792246B2","cleaned_patent_number":"10792246","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-26","publication_date":"2020-10-06","legal_status":"Granted"} US10792246B2 Formulation 06 Oct, 2020 Granted 26 Jun, 2039
{"application_id":"109357","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"3fe43caa796d4e07af34","publication_number":"US11497711B2","cleaned_patent_number":"11497711","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-26","publication_date":"2022-11-15","legal_status":"Granted"} US11497711B2 Formulation 15 Nov, 2022 Granted 26 Jun, 2039
{"application_id":"56443","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"3fe43caa796d4e07af34","publication_number":"US11478422B2","cleaned_patent_number":"11478422","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-26","publication_date":"2022-10-25","legal_status":"Granted"} US11478422B2 Formulation 25 Oct, 2022 Granted 26 Jun, 2039
{"application_id":"109358","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"3fe43caa796d4e07af34","publication_number":"US11517524B2","cleaned_patent_number":"11517524","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-26","publication_date":"2022-12-06","legal_status":"Granted"} US11517524B2 Formulation 06 Dec, 2022 Granted 26 Jun, 2039
{"application_id":"138449","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"","publication_number":"US12109196B2","cleaned_patent_number":"12109196","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-17","publication_date":"2024-10-08","legal_status":"Granted"} US12109196B2 08 Oct, 2024 Granted 17 Jul, 2040
{"application_id":"120604","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"249a676e7dd0441e9fda","publication_number":"US11890272B2","cleaned_patent_number":"11890272","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-17","publication_date":"2024-02-06","legal_status":"Granted"} US11890272B2 06 Feb, 2024 Granted 17 Jul, 2040
{"application_id":"124549","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"","publication_number":"US11998529B2","cleaned_patent_number":"11998529","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-17","publication_date":"2024-06-04","legal_status":"Granted"} US11998529B2 04 Jun, 2024 Granted 17 Jul, 2040
{"application_id":"117259","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"","publication_number":"US11806334B1","cleaned_patent_number":"11806334","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-12","publication_date":"2023-11-07","legal_status":"Granted"} US11806334B2 07 Nov, 2023 Granted 12 Jan, 2043
{"application_id":"130694","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"","publication_number":"US12090140B2","cleaned_patent_number":"12090140","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-12","publication_date":"2024-09-17","legal_status":"Granted"} US12090140B2 17 Sep, 2024 Granted 12 Jan, 2043
{"application_id":"138450","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"","publication_number":"","cleaned_patent_number":"12138247","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-12","publication_date":"2024-11-12","legal_status":"Patented Case"} US12138247B2 12 Nov, 2024 Patented Case 12 Jan, 2043
{"application_id":"124055","ingredient":"DEXMEDETOMIDINE HYDROCHLORIDE","trade_name":"IGALMI","family_id":"","publication_number":"US11998528B1","cleaned_patent_number":"11998528","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-12","publication_date":"2024-06-04","legal_status":"Granted"} US11998528B2 04 Jun, 2024 Granted 12 Jan, 2043

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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