Amisulpride Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as ACACIA. It is marketed under 1 brand name, including BARHEMSYS. Available in 2 different strengths, such as 5MG/2ML (2.5MG/ML), 10MG/4ML (2.5MG/ML), and administered through 1 route including SOLUTION;INTRAVENOUS.

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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":"73163","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"287e9808e92b4f8c9c1a","publication_number":"US10525033B2","cleaned_patent_number":"10525033","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2020-01-07","legal_status":"Granted"} US10525033B2 Formulation 07 Jan, 2020 Granted 10 Mar, 2031
{"application_id":"139385","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"","publication_number":"US12194022B2","cleaned_patent_number":"12194022","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2025-01-14","legal_status":"Granted"} US12194022B2 14 Jan, 2025 Granted 10 Mar, 2031
{"application_id":"73110","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"287e9808e92b4f8c9c1a","publication_number":"US9545426B2","cleaned_patent_number":"9545426","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2017-01-17","legal_status":"Granted"} US9545426B2 17 Jan, 2017 Granted 10 Mar, 2031
{"application_id":"73161","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"287e9808e92b4f8c9c1a","publication_number":"US9889118B2","cleaned_patent_number":"9889118","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2018-02-13","legal_status":"Granted"} US9889118B2 13 Feb, 2018 Granted 10 Mar, 2031
{"application_id":"73159","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"287e9808e92b4f8c9c1a","publication_number":"US9084765B2","cleaned_patent_number":"9084765","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-26","publication_date":"2015-07-21","legal_status":"Granted"} US9084765B2 21 Jul, 2015 Granted 26 Feb, 2034
{"application_id":"242126","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"","publication_number":"US12329740B2","cleaned_patent_number":"12329740","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-02-09","publication_date":"2025-06-17","legal_status":"Granted"} US12329740B2 17 Jun, 2025 Granted 09 Feb, 2038
{"application_id":"73167","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"78ed782915944373ad82","publication_number":"US11357753B2","cleaned_patent_number":"11357753","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-02-09","publication_date":"2022-06-14","legal_status":"Granted"} US11357753B2 14 Jun, 2022 Granted 09 Feb, 2038
{"application_id":"139384","ingredient":"AMISULPRIDE","trade_name":"BARHEMSYS","family_id":"","publication_number":"US12005042B2","cleaned_patent_number":"12005042","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-02-09","publication_date":"2024-06-11","legal_status":"Granted"} US12005042B2 11 Jun, 2024 Granted 09 Feb, 2038

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.