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Profile for Tradename: NAMENDA

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Namenda is a drug marketed by Forest Labs Llc and is included in three NDAs. It is available from eight suppliers. There are eight patents protecting this drug and five Paragraph IV challenges.

The generic ingredient in NAMENDA is memantine hydrochloride. There are twenty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for Tradename: NAMENDA

Patents:8
Applicants:1
NDAs:3
Suppliers / Packagers: see list29
2013 Sales:$1,856,822,000

Pharmacology for Tradename: NAMENDA

Clinical Trials for: NAMENDA

Does Memantine Improve Verbal Memory Task Performance in Subjects With Partial Epilepsy and Memory Dysfunction?
Status: Recruiting Condition: Epilepsy

Down Syndrome Memantine Follow-up Study
Status: Recruiting Condition: Down Syndrome; Intellectual Disability

Efficacy of Memantine add-on in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Patients
Status: Recruiting Condition: Bipolar Disorder

The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?
Status: Not yet recruiting Condition: Major Depressive Disorder

A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Status: Active, not recruiting Condition: Autism Spectrum Disorders

A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease
Status: Completed Condition: Alzheimer's Disease

Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury
Status: Terminated Condition: Traumatic Brain Injury

Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy
Status: Withdrawn Condition: Epilepsy

Memantine and Intensive Speech-Language Therapy in Aphasia
Status: Completed Condition: Aphasia; Stroke

Memantine Augmentation of Antidepressants
Status: Completed Condition: Depressive Disorder

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYes8,329,752*PED<disabled>Y<disabled>
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 2010RXNo5,061,703*PED<disabled>Y<disabled>
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYes8,283,379*PED<disabled>Y<disabled>
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Expired Patents for Tradename: NAMENDA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMENDA
memantine hydrochloride
SOLUTION;ORAL021627-001Apr 18, 20055,061,703*PED<disabled>
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-002Oct 16, 20035,061,703*PED<disabled>
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-002Oct 16, 20035,614,560<disabled>
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Paragraph IV activity for: NAMENDA

Drugname Dosage Strength RLD Submissiondate
memantine hydrochlorideTablets5 mg and 10 mgNamenda10/16/2007
memantine hydrochlorideExtended-release Capsules7 mg, 14 mg, 21 mg, and 28 mgNamenda XR6/10/2013
memantine hydrochlorideExtended-release Capsules7 mg, 14 mg, 21 mgNamenda XR6/17/2013
memantine hydrochlorideExtended-release Capsules28 mgNamenda XR6/12/2013
memantine hydrochlorideExtended-release Capsules7 mg, 14 mg, 21 mg, and 28 mgNamenda XR8/16/2013
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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