Palonosetron Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 19 pharmaceutical companies such as HELSINN HLTHCARE, SANDOZ, AVYXA HOLDINGS and others. It is marketed under 3 brand names, including AKYNZEO, PALONOSETRON HYDROCHLORIDE, POSFREA. Available in 6 different strengths, such as 300MG;EQ 0.5MG BASE, EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML), EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) and others, and administered through 4 routes including CAPSULE;ORAL, INJECTABLE;INTRAVENOUS, SOLUTION;INTRAVENOUS and others.

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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":"45493","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"0aa6b3f3bcd9410fabee","publication_number":"US9943515B2","cleaned_patent_number":"9943515","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-18","publication_date":"2018-04-17","legal_status":"Granted"} US9943515B2 17 Apr, 2018 Granted 18 Nov, 2030
{"application_id":"45560","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"e5c41947226848f6bfc5","publication_number":"US11559523B2","cleaned_patent_number":"11559523","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-18","publication_date":"2023-01-24","legal_status":"Granted"} US11559523B2 Formulation 24 Jan, 2023 Granted 18 Nov, 2030
{"application_id":"130683","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"","publication_number":"US12042494B2","cleaned_patent_number":"12042494","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-18","publication_date":"2024-07-23","legal_status":"Granted"} US12042494B2 Formulation 23 Jul, 2024 Granted 18 Nov, 2030
{"application_id":"45555","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"0aa6b3f3bcd9410fabee","publication_number":"US8623826B2","cleaned_patent_number":"8623826","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-18","publication_date":"2014-01-07","legal_status":"Granted"} US8623826B2 07 Jan, 2014 Granted 18 Nov, 2030
{"application_id":"45556","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"0aa6b3f3bcd9410fabee","publication_number":"US8951969B2","cleaned_patent_number":"8951969","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-18","publication_date":"2015-02-10","legal_status":"Granted"} US8951969B2 Formulation 10 Feb, 2015 Granted 18 Nov, 2030
{"application_id":"45557","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"0aa6b3f3bcd9410fabee","publication_number":"US9186357B2","cleaned_patent_number":"9186357","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-18","publication_date":"2015-11-17","legal_status":"Granted"} US9186357B2 17 Nov, 2015 Granted 18 Nov, 2030
{"application_id":"45559","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"0aa6b3f3bcd9410fabee","publication_number":"US10828297B2","cleaned_patent_number":"10828297","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-17","publication_date":"2020-11-10","legal_status":"Granted"} US10828297B2 10 Nov, 2020 Granted 17 Dec, 2030
{"application_id":"45558","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"0aa6b3f3bcd9410fabee","publication_number":"US9271975B2","cleaned_patent_number":"9271975","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-09","publication_date":"2016-03-01","legal_status":"Granted"} US9271975B2 01 Mar, 2016 Granted 09 Sep, 2031
{"application_id":"66288","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"b1991e14fe7744198ed2","publication_number":"US8895586B2","cleaned_patent_number":"8895586","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2014-11-25","legal_status":"Granted"} US8895586B2 25 Nov, 2014 Granted 23 May, 2032
{"application_id":"66289","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"b1991e14fe7744198ed2","publication_number":"US9403772B2","cleaned_patent_number":"9403772","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2016-08-02","legal_status":"Granted"} US9403772B2 Molecular 02 Aug, 2016 Granted 23 May, 2032
{"application_id":"66291","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"b1991e14fe7744198ed2","publication_number":"US10717721B2","cleaned_patent_number":"10717721","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2020-07-21","legal_status":"Granted"} US10717721B2 Molecular 21 Jul, 2020 Granted 23 May, 2032
{"application_id":"66233","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"b1991e14fe7744198ed2","publication_number":"US10208073B2","cleaned_patent_number":"10208073","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2019-02-19","legal_status":"Granted"} US10208073B2 19 Feb, 2019 Granted 23 May, 2032
{"application_id":"66292","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"b1991e14fe7744198ed2","publication_number":"US11312698B2","cleaned_patent_number":"11312698","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2022-04-26","legal_status":"Patented case"} US11312698B2 Molecular Formulation 26 Apr, 2022 Patented case 23 May, 2032
{"application_id":"66290","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"b1991e14fe7744198ed2","publication_number":"US9908907B2","cleaned_patent_number":"9908907","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2018-03-06","legal_status":"Granted"} US9908907B2 Molecular Formulation 06 Mar, 2018 Granted 23 May, 2032
{"application_id":"66287","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"b1991e14fe7744198ed2","publication_number":"US8426450B1","cleaned_patent_number":"8426450","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-23","publication_date":"2013-04-23","legal_status":"Patented case"} US8426450B2 Molecular Formulation 23 Apr, 2013 Patented case 23 May, 2032
{"application_id":"45575","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"bb9ef7f9aec04ced8017","publication_number":"US9951016B2","cleaned_patent_number":"9951016","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-25","publication_date":"2018-04-24","legal_status":"Granted"} US9951016B2 Molecular Formulation 24 Apr, 2018 Granted 25 Sep, 2035
{"application_id":"45567","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"bb9ef7f9aec04ced8017","publication_number":"US10233154B2","cleaned_patent_number":"10233154","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-25","publication_date":"2019-03-19","legal_status":"Granted"} US10233154B2 Molecular 19 Mar, 2019 Granted 25 Sep, 2035
{"application_id":"45576","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"bb9ef7f9aec04ced8017","publication_number":"US10676440B2","cleaned_patent_number":"10676440","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-25","publication_date":"2020-06-09","legal_status":"Granted"} US10676440B2 Molecular Formulation 09 Jun, 2020 Granted 25 Sep, 2035
{"application_id":"45577","ingredient":"NETUPITANT; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"bb9ef7f9aec04ced8017","publication_number":"US10961195B2","cleaned_patent_number":"10961195","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-25","publication_date":"2021-03-30","legal_status":"Granted"} US10961195B2 Molecular Formulation 30 Mar, 2021 Granted 25 Sep, 2035
{"application_id":"164425","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"dc86d787d12542f198e3","publication_number":"US12208109B2","cleaned_patent_number":"12208109","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-02","publication_date":"2025-01-28","legal_status":"Granted"} US12208109B2 Formulation 28 Jan, 2025 Granted 02 Jun, 2037
{"application_id":"66330","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"dc86d787d12542f198e3","publication_number":"US11529362B2","cleaned_patent_number":"11529362","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-02","publication_date":"2022-12-20","legal_status":"Granted"} US11529362B2 Formulation 20 Dec, 2022 Granted 02 Jun, 2037
{"application_id":"66298","ingredient":"FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE","trade_name":"AKYNZEO","family_id":"dc86d787d12542f198e3","publication_number":"US10624911B2","cleaned_patent_number":"10624911","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-06-02","publication_date":"2020-04-21","legal_status":"Granted"} US10624911B2 Formulation 21 Apr, 2020 Granted 02 Jun, 2037

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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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