Enalapril Maleate Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 8 pharmaceutical companies such as AZURITY, BIONPHARMA, ANNORA PHARMA and others. It is marketed under 3 brand names, including EPANED KIT, EPANED, ENALAPRIL MALEATE. Available in 5 different strengths, such as 1MG/ML, 2.5MG, 5MG and others, and administered through 3 routes including FOR SOLUTION;ORAL, SOLUTION;ORAL, TABLET;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":"56965","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED KIT","family_id":"49e4b50cfbf94af1ae8d","publication_number":"US8568747B1","cleaned_patent_number":"8568747","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-06","publication_date":"2013-10-29","legal_status":"Granted"} US8568747B2 Formulation 29 Oct, 2013 Granted 06 Nov, 2032
{"application_id":"56960","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED KIT","family_id":"49e4b50cfbf94af1ae8d","publication_number":"US8778366B2","cleaned_patent_number":"8778366","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-06","publication_date":"2014-07-15","legal_status":"Granted"} US8778366B2 15 Jul, 2014 Granted 06 Nov, 2032
{"application_id":"56966","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED KIT","family_id":"49e4b50cfbf94af1ae8d","publication_number":"US9855214B2","cleaned_patent_number":"9855214","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-06","publication_date":"2018-01-02","legal_status":"Granted"} US9855214B2 Formulation 02 Jan, 2018 Granted 06 Nov, 2032
{"application_id":"56967","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED KIT","family_id":"49e4b50cfbf94af1ae8d","publication_number":"US9968553B1","cleaned_patent_number":"9968553","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-11-06","publication_date":"2018-05-15","legal_status":"Granted"} US9968553B2 15 May, 2018 Granted 06 Nov, 2032
{"application_id":"76172","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US11040023B2","cleaned_patent_number":"11040023","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2021-06-22","legal_status":"Granted"} US11040023B2 Formulation 22 Jun, 2021 Granted 25 Mar, 2036
{"application_id":"76173","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US11141405B2","cleaned_patent_number":"11141405","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2021-10-12","legal_status":"Granted"} US11141405B2 Formulation 12 Oct, 2021 Granted 25 Mar, 2036
{"application_id":"76166","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US10039745B2","cleaned_patent_number":"10039745","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2018-08-07","legal_status":"Patented case"} US10039745B2 Formulation 07 Aug, 2018 Patented case 25 Mar, 2036
{"application_id":"76165","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US9669008B1","cleaned_patent_number":"9669008","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2017-06-06","legal_status":"Granted"} US9669008B2 Formulation 06 Jun, 2017 Granted 25 Mar, 2036
{"application_id":"76162","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US9808442B2","cleaned_patent_number":"9808442","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2017-11-07","legal_status":"Granted"} US9808442B2 07 Nov, 2017 Granted 25 Mar, 2036
{"application_id":"76174","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US11173141B2","cleaned_patent_number":"11173141","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2021-11-16","legal_status":"Granted"} US11173141B2 Formulation 16 Nov, 2021 Granted 25 Mar, 2036
{"application_id":"76167","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US10154987B2","cleaned_patent_number":"10154987","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2018-12-18","legal_status":"Patented case"} US10154987B2 18 Dec, 2018 Patented case 25 Mar, 2036
{"application_id":"76168","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US10772868B2","cleaned_patent_number":"10772868","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2020-09-15","legal_status":"Patented case"} US10772868B2 Formulation 15 Sep, 2020 Patented case 25 Mar, 2036
{"application_id":"76169","ingredient":"ENALAPRIL MALEATE","trade_name":"EPANED","family_id":"7c7bb16aad31409babd4","publication_number":"US10786482B2","cleaned_patent_number":"10786482","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-25","publication_date":"2020-09-29","legal_status":"Patented case"} US10786482B2 Formulation 29 Sep, 2020 Patented case 25 Mar, 2036

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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