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Generated: October 19, 2018

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DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for donepezil hydrochloride; memantine hydrochloride and what is the scope of donepezil hydrochloride; memantine hydrochloride patent protection?

Donepezil hydrochloride; memantine hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms and Allergan Sales Llc, and is included in two NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for donepezil hydrochloride; memantine hydrochloride. Two suppliers are listed for this compound.

Pharmacology for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

US Patents and Regulatory Information for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998 Austria ➤ Sign Up PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
C/GB97/023 United Kingdom ➤ Sign Up PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
QuintilesIMS
Express Scripts
Chinese Patent Office
Boehringer Ingelheim
Teva
McKesson
Medtronic

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