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Last Updated: December 9, 2019

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NAMZARIC Drug Profile

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When do Namzaric patents expire, and when can generic versions of Namzaric launch?

Namzaric is a drug marketed by Allergan Sales Llc and is included in one NDA. There are twelve patents protecting this drug and three Paragraph IV challenges.

This drug has seventy patent family members in twenty countries.

The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

Drug patent expirations by year for NAMZARIC
Drug Prices for NAMZARIC

See drug prices for NAMZARIC

Recent Clinical Trials for NAMZARIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Suven Life Sciences LimitedPhase 2

See all NAMZARIC clinical trials

Recent Litigation for NAMZARIC

Identify potential future generic entrants

District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
Allergan Sales LLC v. Macleods Pharmaceuticals, Ltd.2017-06-02
Forest Laboratories, LLC v. Macleods Pharmaceuticals, Ltd.2017-06-02

See all NAMZARIC litigation

PTAB Litigation
PetitionerDate
Ranbaxy, Inc.2014-12-18

See all NAMZARIC litigation

Synonyms for NAMZARIC
914296-81-4
Aricept and Namenda
Donepezil / memantine
Donepezil and memantine
Donepezil HCl and memantine HCl
Donepezil hydrochloride mixture with memantine hydrochloride
Paragraph IV (Patent) Challenges for NAMZARIC
Tradename Dosage Ingredient NDA Submissiondate
NAMZARIC CAPSULE, EXTENDED RELEASE;ORAL donepezil hydrochloride; memantine hydrochloride 206439 2016-09-26
NAMZARIC CAPSULE, EXTENDED RELEASE;ORAL donepezil hydrochloride; memantine hydrochloride 206439 2016-09-23
NAMZARIC CAPSULE, EXTENDED RELEASE;ORAL donepezil hydrochloride; memantine hydrochloride 206439 2015-05-18

US Patents and Regulatory Information for NAMZARIC

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 206439-002 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NAMZARIC

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

Supplementary Protection Certificates for NAMZARIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 2/1998 Austria   Start Trial 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
0296560 SPC/GB97/023 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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