Amlodipine Benzoate Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as AZURITY, AMNEAL. It is marketed under 2 brand names, including KATERZIA, AMLODIPINE BENZOATE. Available in 1 different strength, such as EQ 1MG BASE/ML, and administered through 1 route including SUSPENSION;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":"242148","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"","publication_number":"US12336984B2","cleaned_patent_number":"12336984","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2025-06-24","legal_status":"Granted"} US12336984B2 24 Jun, 2025 Granted 06 Oct, 2037
{"application_id":"122913","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"abee6ff2e3ce4f1c9d6b","publication_number":"US11918685B2","cleaned_patent_number":"11918685","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2024-03-05","legal_status":"Granted"} US11918685B2 05 Mar, 2024 Granted 06 Oct, 2037
{"application_id":"130720","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"","publication_number":"US12053461B2","cleaned_patent_number":"12053461","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2024-08-06","legal_status":"Granted"} US12053461B2 Formulation 06 Aug, 2024 Granted 06 Oct, 2037
{"application_id":"83050","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"2b883763d0414c60b7e5","publication_number":"US10894039B2","cleaned_patent_number":"10894039","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2021-01-19","legal_status":"Granted"} US10894039B2 19 Jan, 2021 Granted 06 Oct, 2037
{"application_id":"83051","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"2b883763d0414c60b7e5","publication_number":"US10952998B2","cleaned_patent_number":"10952998","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2021-03-23","legal_status":"Granted"} US10952998B2 Formulation 23 Mar, 2021 Granted 06 Oct, 2037
{"application_id":"83044","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"2b883763d0414c60b7e5","publication_number":"US10959991B2","cleaned_patent_number":"10959991","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2021-03-30","legal_status":"Granted"} US10959991B2 30 Mar, 2021 Granted 06 Oct, 2037
{"application_id":"83052","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"2b883763d0414c60b7e5","publication_number":"US11364230B2","cleaned_patent_number":"11364230","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2022-06-21","legal_status":"Granted"} US11364230B2 Formulation 21 Jun, 2022 Granted 06 Oct, 2037
{"application_id":"83060","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"abee6ff2e3ce4f1c9d6b","publication_number":"US11471409B2","cleaned_patent_number":"11471409","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2022-10-18","legal_status":"Granted"} US11471409B2 18 Oct, 2022 Granted 06 Oct, 2037
{"application_id":"108756","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"abee6ff2e3ce4f1c9d6b","publication_number":"US11484498B2","cleaned_patent_number":"11484498","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2022-11-01","legal_status":"Granted"} US11484498B2 Formulation 01 Nov, 2022 Granted 06 Oct, 2037
{"application_id":"116355","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"abee6ff2e3ce4f1c9d6b","publication_number":"US11701326B2","cleaned_patent_number":"11701326","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-06","publication_date":"2023-07-18","legal_status":"Granted"} US11701326B2 Formulation 18 Jul, 2023 Granted 06 Oct, 2037
{"application_id":"83049","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"2b883763d0414c60b7e5","publication_number":"US10695329B2","cleaned_patent_number":"10695329","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-16","publication_date":"2020-06-30","legal_status":"Granted"} US10695329B2 Formulation 30 Jun, 2020 Granted 16 Oct, 2037
{"application_id":"83055","ingredient":"AMLODIPINE BENZOATE","trade_name":"KATERZIA","family_id":"abee6ff2e3ce4f1c9d6b","publication_number":"US10799453B2","cleaned_patent_number":"10799453","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-04-11","publication_date":"2020-10-13","legal_status":"Patented case"} US10799453B2 Formulation 13 Oct, 2020 Patented case 11 Apr, 2039

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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