Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for donepezil hydrochloride; memantine hydrochloride and what is the scope of 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.

Donepezil hydrochloride; memantine hydrochloride has sixty-nine patent family members in nineteen countries.

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

Recent Clinical Trials for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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SponsorPhase
Zealand University HospitalPhase 4
Epilepsihospitalet FiladelfiaPhase 4
AllerganPhase 1

See all DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE clinical trials

Recent Litigation for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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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 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE litigation

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

See all DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE litigation

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MG;28MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial10MG;14MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial10MG;28MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
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 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 206439-004 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 206439-004 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 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial   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 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 206439-001 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 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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