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Profile for Tradename: NAMENDA

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

The generic ingredient in NAMENDA is memantine hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. There are eleven 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: see list7
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

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

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Status: Withdrawn Condition: Epilepsy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

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

Memantine Therapy for Multiple Sclerosis
Status: Terminated Condition: Multiple Sclerosis

Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
Status: Terminated Condition: Alzheimer's Disease

Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study
Status: Completed Condition: Attention Deficit Hyperactivity Disorder (ADHD); Executive Function Deficits (EFD)

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525Jun 21, 2010RXNo8,362,085*PED<disabled>Y<disabled>
Forest Labs
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525Jun 21, 2010RXYes8,039,009*PED<disabled>Y<disabled>
Forest Labs
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525Jun 21, 2010RXYes8,329,752*PED<disabled>Y<disabled>
Forest Labs
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525Jun 21, 2010RXYes<disabled><disabled>
Forest Labs
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525Jun 21, 2010RXNo8,039,009*PED<disabled>Y<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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