Memantine Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 37 pharmaceutical companies such as DR REDDYS LABS LTD, SUN PHARM, ABBVIE and others. It is marketed under 4 brand names, including MEMANTINE HYDROCHLORIDE, NAMENDA XR, NAMZARIC and others. Available in 11 different strengths, such as 5MG, 10MG, 21MG and others, and administered through 3 routes including TABLET;ORAL, CAPSULE, EXTENDED RELEASE;ORAL, SOLUTION;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":"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":"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":"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":"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":"44557","ingredient":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","trade_name":"NAMENDA XR","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

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.