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Last Updated: November 21, 2024

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 Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-one 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
University of ChicagoPhase 2/Phase 3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Early Phase 1
Children's Hospital Medical Center, CincinnatiEarly Phase 1

See all NAMENDA XR clinical trials

Pharmacology 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
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ⤷  Sign Up ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 ⤷  Sign Up ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 ⤷  Sign Up ⤷  Sign Up
Abbvie NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for NAMENDA XR

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 NAMENDA XR

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

Country Patent Number Title Estimated Expiration
Denmark 91690 ⤷  Sign Up
European Patent Office 2343057 Procédé et composition pour l'administration d'un antagoniste du récepteur NMDA à un sujet (Method and composition for administering an NMDA receptor antagonist to a subject) ⤷  Sign Up
Australia 2005215775 Combination of a NMDA receptor antagonist and an anti-depressive drug mao-inhibitor or a GADPH-inhibitor for the treatment of psychiatric conditions ⤷  Sign Up
South Korea 20070116996 METHODS AND COMPOSITIONS FOR TREATMENT OF CNS DISORDERS ⤷  Sign Up
Australia 2005215767 Combination of an NMDA receptor antagonist and an anti-epileptic drug for the treatment of epilepsy and other CNS disorders ⤷  Sign Up
Canada 2588295 PROCEDE ET COMPOSITION POUR ADMINISTRER UN ANTAGONISTE DU RECEPTEUR DE NMDA A UN SUJET (COMPOSITION COMPRISING A SUSTAINED RELEASE COATING OR MATRIXAND AN NMDA RECEPTOR ANTAGONIST, METHOD FOR ADMINISTRATION SUCH NMDA ANTAGONIST TO A SUBJECT) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NAMENDA XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 SPC/GB02/046 United Kingdom ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059 0290025-6 Sweden ⤷  Sign Up PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0392059 90988 Luxembourg ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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