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Last Updated: May 19, 2022

NAMENDA XR Drug Patent Profile


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Which patents cover Namenda Xr, and when can generic versions of Namenda Xr launch?

Namenda Xr is a drug marketed by Allergan and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in ten countries.

The generic ingredient in NAMENDA XR 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Namenda Xr

A generic version of NAMENDA XR was approved as memantine hydrochloride by DR REDDYS LABS LTD on April 14th, 2010.

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Drug patent expirations by year for NAMENDA XR
Drug Prices for NAMENDA XR

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Drug Sales Revenue Trends for NAMENDA XR

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Recent Clinical Trials for NAMENDA XR

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

SponsorPhase
Medical College of WisconsinPhase 2
Children's Oncology GroupPhase 3
Mayo ClinicEarly Phase 1

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Pharmacology for NAMENDA XR
Anatomical Therapeutic Chemical (ATC) Classes for NAMENDA XR
Paragraph IV (Patent) Challenges for NAMENDA XR
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

US Patents and Regulatory Information for NAMENDA XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 See Plans and Pricing See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 See Plans and Pricing See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 See Plans and Pricing See Plans and Pricing
Allergan NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NAMENDA XR

See the table below for patents covering NAMENDA XR around the world.

Country Patent Number Title Estimated Expiration
Canada 2554959 COMBINAISON D'ANTAGONISTE DE RECEPTEUR NMDA ET D'INHIBITEUR MAO OU GADPF POUR LE TRAITEMENT D'AFFECTIONS LIEES AU SYSTEME NERVEUX CENTRAL (COMBINATION OF A NMDA RECEPTOR ANTAGONIST AND A MAO-INHIBITOR OR A GADPF-INHIBITOR FOR THE TREATMENT OF CENTRAL NERVOUS SYSTEM-RELATED CONDITIONS) See Plans and Pricing
Russian Federation 2007122410 КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОСНОВУ ИЛИ ПОКРЫТИЕ ДЛЯ ЗАМЕДЛЕННОГО ВЫСВОБОЖДЕНИЯ И АНТАГОНИСТ NMDA-РЕЦЕПТОРА, СПОСОБ ВВЕДЕНИЯ ТАКОГО NMDA-АНТАГОНИСТА СУБЪЕКТУ See Plans and Pricing
Israel 183384 See Plans and Pricing
Hungary T58200 See Plans and Pricing
China 101247795 Methods and compositions for treatment of CNS disorders See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NAMENDA XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 2002C/035 Belgium See Plans and Pricing PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059 SPC/GB02/046 United Kingdom See Plans and Pricing 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 0290025-6 Sweden See Plans and Pricing PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0392059 90988 Luxembourg See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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