You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
McKesson
Johnson and Johnson
Merck
Baxter

Last Updated: February 22, 2024

Memantine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, 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, Cadila, Celltrion, 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, Westminster Pharms, and Yiling, 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. Thirty-eight 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
University of ChicagoPhase 2/Phase 3
Simon Ducharme, MDPhase 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
Sun Pharm MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205905-004 Sep 28, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203293-003 Aug 3, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 207236-002 Nov 10, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205825-004 Oct 12, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 200891-001 Oct 13, 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 XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 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 021487-001 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
China 1968684 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
European Patent Office 1781261 FORMULATION DE LIBERATION MODIFIEE DE MEMANTINE (MODIFIED RELEASE FORMULATION OF MEMANTINE) ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Express Scripts
Dow
McKesson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.