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Last Updated: August 10, 2020

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NAMENDA Drug Profile

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When do Namenda patents expire, and what generic alternatives are available?

Namenda is a drug marketed by Allergan and Forest Labs Llc and is included in three NDAs. There are seven patents protecting this drug and five Paragraph IV challenges.

The generic ingredient in NAMENDA is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.

Drug patent expirations by year for NAMENDA
Drug Prices for NAMENDA

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Drug Sales Revenue Trends for NAMENDA

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Recent Clinical Trials for NAMENDA

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SponsorPhase
National Cancer Institute (NCI)Early Phase 1
Mayo ClinicEarly Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2

See all NAMENDA clinical trials

Pharmacology for NAMENDA
Paragraph IV (Patent) Challenges for NAMENDA
Tradename Dosage Ingredient NDA Submissiondate
NAMENDA TABLET;ORAL memantine hydrochloride 021487 2007-10-16

US Patents and Regulatory Information for NAMENDA

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
Allergan NAMENDA memantine hydrochloride SOLUTION;ORAL 021627-001 Apr 18, 2005 DISCN Yes No   Start Trial   Start Trial   Start Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 AB RX Yes No   Start Trial   Start Trial Y   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 NAMENDA

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
Allergan NAMENDA memantine hydrochloride SOLUTION;ORAL 021627-001 Apr 18, 2005   Start Trial   Start Trial
Allergan NAMENDA memantine hydrochloride TABLET;ORAL 021487-001 Oct 16, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NAMENDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0392059 2002C/035 Belgium   Start Trial PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059 90988 Luxembourg   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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