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Last Updated: March 29, 2024

MEMANTINE HYDROCHLORIDE - Generic Drug Details


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What are the generic 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, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Abbvie, Apozeal Pharms, Chartwell Molecular, Macleods Pharms Ltd, Seton Pharms, Allergan, Ajanta Pharma Ltd, Alembic, Celltrion, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Renata, 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.

Recent Clinical Trials for MEMANTINE HYDROCHLORIDE

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

SponsorPhase
Mansoura UniversityPhase 1/Phase 2
Alzheimer's Drug Discovery FoundationPhase 3
University of ChicagoPhase 2/Phase 3

See all MEMANTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial28MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a Trial21MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a 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 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
Apotex MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206135-002 Nov 22, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiamen Lp Pharm Co MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 213985-001 Oct 11, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 214651-003 Aug 9, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Puracap Pharm Llc MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 206855-002 Nov 17, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003 ⤷  Try a Trial ⤷  Try a Trial
Allergan NAMENDA memantine hydrochloride SOLUTION;ORAL 021627-001 Apr 18, 2005 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003 ⤷  Try a Trial ⤷  Try a Trial
>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
Mexico PA06014587 FORMULACIONES DE LIBERACION MODIFICADA DE FORMULACIONES DE DOSIFICACION ORAL DE MEMANTINA. (MODIFIED RELEASE FORMULATION OF MEMANTINE.) ⤷  Try a Trial
Australia 2005265031 Modified release formulation of memantine ⤷  Try a Trial
Japan 2008503475 ⤷  Try a Trial
Eurasian Patent Organization 200700049 ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ ⤷  Try a Trial
>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 ⤷  Try a 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
0392059 2002C/035 Belgium ⤷  Try a Trial 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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