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Last Updated: October 26, 2021

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Memantine hydrochloride - Generic Drug Details

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

Memantine hydrochloride is the generic ingredient in three branded drugs marketed by Amneal Pharms, Anchen Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Sun Pharm, Yichang Humanwell, Zydus Pharms, Forest Labs Llc, Lannett Co Inc, Macleods Pharms Ltd, Seton Pharms, Torrent, Allergan, Ajanta Pharma Ltd, Alembic Pharms Ltd, Cadila, Celltrion, Chartwell, Cspc Ouyi, Dr Reddys Labs Ltd, Hikma, Jubilant Generics, Ningbo, Orchid Hlthcare, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in forty-three NDAs. There is one patent protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Memantine hydrochloride has eleven patent family members in ten countries.

There are twenty-eight drug master file entries for memantine hydrochloride. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for memantine hydrochloride

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

SponsorPhase
Medical College of WisconsinPhase 2
University of VirginiaPhase 2
University of Roma La SapienzaPhase 3

See all memantine hydrochloride clinical trials

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial28MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial21MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial14MGCAPSULE, 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 memantine hydrochloride
Medical Subject Heading (MeSH) Categories for memantine hydrochloride
Paragraph IV (Patent) Challenges for MEMANTINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
NAMENDA XR CAPSULE, EXTENDED RELEASE;ORAL memantine hydrochloride 022525 2013-06-10
NAMENDA TABLET;ORAL memantine hydrochloride 021487 2007-10-16

US Patents and Regulatory Information for memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205905-003 Sep 28, 2016 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Orchid Hlthcare MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090044-001 Mar 12, 2012 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Strides Pharma MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 202350-001 May 23, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan NAMENDA memantine hydrochloride TABLET;ORAL 021487-001 Oct 16, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for memantine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 2002C/035 Belgium ⤷  Free Forever Trial PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059 SPC/GB02/046 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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