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Last Updated: July 16, 2020

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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 Inc, Apotex, Lupin Ltd, Mylan, Sun Pharm, Zydus Pharms, Forest Labs Llc, Lannett Co Inc, Macleods Pharms Ltd, Torrent, Allergan, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Celltrion, Chartwell, Cspc Ouyi, Dr Reddys Labs Ltd, Hikma Pharms, Jubilant Generics, Ningbo, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Unichem Labs Ltd, and Upsher Smith Labs, and is included in thirty-nine NDAs. There are seven patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Memantine hydrochloride has seventy patent family members in twenty countries.

There are twenty-eight drug master file entries for memantine hydrochloride. Thirty-eight 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
National Cancer Institute (NCI)Early Phase 1
Mayo ClinicEarly Phase 1
Epilepsihospitalet FiladelfiaPhase 4

See all memantine hydrochloride clinical trials

Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial28MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial21MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start 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
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amneal Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205825-002 Oct 12, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Chartwell MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090244-001 Jul 11, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203293-004 Aug 3, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 200022-001 Oct 13, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride SOLUTION;ORAL 202790-001 Oct 13, 2015 AA RX No 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 memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003   Start Trial   Start Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010   Start Trial   Start Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010   Start Trial   Start Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010   Start Trial   Start Trial
Allergan NAMENDA memantine hydrochloride SOLUTION;ORAL 021627-001 Apr 18, 2005   Start Trial   Start Trial
Allergan NAMENDA memantine hydrochloride SOLUTION;ORAL 021627-001 Apr 18, 2005   Start Trial   Start Trial
Allergan NAMENDA memantine hydrochloride TABLET;ORAL 021487-002 Oct 16, 2003   Start Trial   Start 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   Start Trial PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059 SPC/GB02/046 United Kingdom   Start 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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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
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Dow
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Baxter

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