Donepezil Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 43 pharmaceutical companies such as EISAI INC, SUN PHARM INDS LTD, CHARTWELL RX and others. It is marketed under 5 brand names, including ARICEPT, DONEPEZIL HYDROCHLORIDE, NAMZARIC and others. Available in 9 different strengths, such as 23MG, 10MG, 5MG and others, and administered through 4 routes including TABLET;ORAL, TABLET, ORALLY DISINTEGRATING;ORAL, CAPSULE, EXTENDED RELEASE;ORAL 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":"44636","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8580858B2","cleaned_patent_number":"8580858","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-22","publication_date":"2013-11-12","legal_status":"Granted"} US8580858B2 12 Nov, 2013 Granted 22 Nov, 2025
{"application_id":"44633","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8338486B2","cleaned_patent_number":"8338486","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-22","publication_date":"2012-12-25","legal_status":"Granted"} US8338486B2 25 Dec, 2012 Granted 22 Nov, 2025
{"application_id":"44630","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8293794B2","cleaned_patent_number":"8293794","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-22","publication_date":"2012-10-23","legal_status":"Granted"} US8293794B2 Formulation 23 Oct, 2012 Granted 22 Nov, 2025
{"application_id":"44632","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8338485B2","cleaned_patent_number":"8338485","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-22","publication_date":"2012-12-25","legal_status":"Granted"} US8338485B2 Formulation 25 Dec, 2012 Granted 22 Nov, 2025
{"application_id":"44631","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8329752B2","cleaned_patent_number":"8329752","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-22","publication_date":"2012-12-11","legal_status":"Granted"} US8329752B2 11 Dec, 2012 Granted 22 May, 2026
{"application_id":"44634","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8362085B2","cleaned_patent_number":"8362085","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-22","publication_date":"2013-01-29","legal_status":"Granted"} US8362085B2 29 Jan, 2013 Granted 22 May, 2026
{"application_id":"44577","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8598233B2","cleaned_patent_number":"8598233","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-22","publication_date":"2013-12-03","legal_status":"Granted"} US8598233B2 03 Dec, 2013 Granted 22 May, 2026
{"application_id":"44627","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8168209B2","cleaned_patent_number":"8168209","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-22","publication_date":"2012-05-01","legal_status":"Granted"} US8168209B2 01 May, 2012 Granted 22 May, 2026
{"application_id":"44628","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8173708B2","cleaned_patent_number":"8173708","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-22","publication_date":"2012-05-08","legal_status":"Granted"} US8173708B2 08 May, 2012 Granted 22 May, 2026
{"application_id":"44629","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8283379B2","cleaned_patent_number":"8283379","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-22","publication_date":"2012-10-09","legal_status":"Granted"} US8283379B2 09 Oct, 2012 Granted 22 May, 2026
{"application_id":"90067","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ARICEPT","family_id":"b65b580e85df401d9124","publication_number":"US8481565B2","cleaned_patent_number":"8481565","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-10-04","publication_date":"2013-07-09","legal_status":"Granted"} US8481565B2 Formulation 09 Jul, 2013 Granted 04 Oct, 2026
{"application_id":"44557","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"f98b873038954985adee","publication_number":"US8039009B2","cleaned_patent_number":"8039009","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-24","publication_date":"2011-10-18","legal_status":"Granted"} US8039009B2 18 Oct, 2011 Granted 24 Sep, 2029
{"application_id":"44626","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMZARIC","family_id":"2bf5076acef14d0fb1e7","publication_number":"US8058291B2","cleaned_patent_number":"8058291","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-05","publication_date":"2011-11-15","legal_status":"Granted"} US8058291B2 15 Nov, 2011 Granted 05 Dec, 2029
{"application_id":"139406","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"c3235fe8151e4f039edf","publication_number":"US12161767B2","cleaned_patent_number":"12161767","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-30","publication_date":"2024-12-10","legal_status":"Granted"} US12161767B2 Molecular Formulation 10 Dec, 2024 Granted 30 Dec, 2036
{"application_id":"139407","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"c3235fe8151e4f039edf","publication_number":"US12168075B2","cleaned_patent_number":"12168075","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-30","publication_date":"2024-12-17","legal_status":"Granted"} US12168075B2 17 Dec, 2024 Granted 30 Dec, 2036
{"application_id":"83628","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"c3235fe8151e4f039edf","publication_number":"US11679086B2","cleaned_patent_number":"11679086","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-26","publication_date":"2023-06-20","legal_status":"Granted"} US11679086B2 20 Jun, 2023 Granted 26 May, 2037
{"application_id":"83675","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"1cb491c7c2ff49f48921","publication_number":"US9993466B2","cleaned_patent_number":"9993466","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-26","publication_date":"2018-06-12","legal_status":"Granted"} US9993466B2 Formulation 12 Jun, 2018 Granted 26 Jul, 2037
{"application_id":"83677","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"1cb491c7c2ff49f48921","publication_number":"US10300025B2","cleaned_patent_number":"10300025","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-26","publication_date":"2019-05-28","legal_status":"Granted"} US10300025B2 Formulation 28 May, 2019 Granted 26 Jul, 2037
{"application_id":"83678","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"1cb491c7c2ff49f48921","publication_number":"US10307379B2","cleaned_patent_number":"10307379","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-26","publication_date":"2019-06-04","legal_status":"Granted"} US10307379B2 Formulation 04 Jun, 2019 Granted 26 Jul, 2037
{"application_id":"83632","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"1cb491c7c2ff49f48921","publication_number":"US11103463B2","cleaned_patent_number":"11103463","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-26","publication_date":"2021-08-31","legal_status":"Granted"} US11103463B2 31 Aug, 2021 Granted 26 Jul, 2037
{"application_id":"83676","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"1cb491c7c2ff49f48921","publication_number":"US10016372B2","cleaned_patent_number":"10016372","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-26","publication_date":"2018-07-10","legal_status":"Granted"} US10016372B2 10 Jul, 2018 Granted 26 Jul, 2037
{"application_id":"83627","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"c3235fe8151e4f039edf","publication_number":"US11648214B2","cleaned_patent_number":"11648214","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-09-23","publication_date":"2023-05-16","legal_status":"Granted"} US11648214B2 Formulation 16 May, 2023 Granted 23 Sep, 2037
{"application_id":"83626","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"c3235fe8151e4f039edf","publication_number":"US10835499B2","cleaned_patent_number":"10835499","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-05-20","publication_date":"2020-11-17","legal_status":"Granted"} US10835499B2 Formulation 17 Nov, 2020 Granted 20 May, 2038
{"application_id":"83615","ingredient":"DONEPEZIL HYDROCHLORIDE","trade_name":"ADLARITY","family_id":"c3235fe8151e4f039edf","publication_number":"US10966936B2","cleaned_patent_number":"10966936","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-11","publication_date":"2021-04-06","legal_status":"Granted"} US10966936B2 Formulation 06 Apr, 2021 Granted 11 Aug, 2038

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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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