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Last Updated: November 4, 2024

Memantine hydrochloride - Generic Drug Details


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What are the generic sources for memantine hydrochloride and what is the scope of freedom to operate?

Memantine hydrochloride is the generic ingredient in three branded drugs marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Abbvie, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, Allergan, Acme Labs, Ajanta Pharma Ltd, Alembic, Allied, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences, and is included in forty-five 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 ten patent family members in nine countries.

There are twenty-eight drug master file entries for memantine hydrochloride. Forty suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for memantine hydrochloride
Recent Clinical Trials for memantine hydrochloride

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

SponsorPhase
NeuroSense Therapeutics Ltd.Phase 2
Mansoura UniversityPhase 1/Phase 2
Simon Ducharme, MDPhase 3

See all memantine hydrochloride clinical trials

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up28MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up21MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up14MGCAPSULE, 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
Anatomical Therapeutic Chemical (ATC) Classes for memantine hydrochloride
Paragraph IV (Patent) Challenges for MEMANTINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NAMENDA XR Extended-release Capsules memantine hydrochloride 7 mg, 14 mg, 21 mg, and 28 mg 022525 1 2013-06-10
NAMENDA Tablets memantine hydrochloride 5 mg and 10 mg 021487 14 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
Yichang Humanwell MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211100-001 Apr 2, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090048-002 Apr 14, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ajanta Pharma Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 206528-002 Nov 30, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 202840-001 Oct 13, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Abbvie NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003 ⤷  Sign Up ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 ⤷  Sign Up ⤷  Sign Up
Abbvie NAMENDA memantine hydrochloride TABLET;ORAL 021487-001 Oct 16, 2003 ⤷  Sign Up ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for memantine hydrochloride

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merz Pharmaceuticals GmbH   Memantine Merz memantine hydrochloride EMEA/H/C/002711
Treatment of patients with moderate to severe Alzheimer’s disease.
Authorised no no no 2012-11-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for memantine hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 1781261 FORMULATION DE LIBERATION MODIFIEE DE MEMANTINE (MODIFIED RELEASE FORMULATION OF MEMANTINE) ⤷  Sign Up
Australia 2005265031 Modified release formulation of memantine ⤷  Sign Up
Eurasian Patent Organization 011446 ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (PREPARATORY SOLID ORAL DOSAGE FORM OF MEMANTINE WITH MODIFIED RELEASE) ⤷  Sign Up
China 1968684 Modified release formulation of memantine ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for memantine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 SPC/GB02/046 United Kingdom ⤷  Sign Up 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
0392059 2002C/035 Belgium ⤷  Sign Up PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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