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NAMENDA Drug Profile

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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.

This drug has twenty-one patent family members in fifteen countries.

The generic ingredient in NAMENDA is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Thirty-four 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 list8
Drug Prices: :see details

Pharmacology for Tradename: NAMENDA

Clinical Trials for: NAMENDA

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, 2010RXYes5,061,703*PEDOct 11, 2015
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 2010RXNo8,362,085*PEDMay 22, 2026Y
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYes8,039,009*PEDSep 24, 2029Y
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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;ORAL021487-001Oct 16, 20035,614,560<disabled>
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-001Oct 16, 20035,061,703*PED<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

International Patent Family for Tradename: NAMENDA

Country Document Number Estimated Expiration
Hungary902434<disabled in preview>
Netherlands300107<disabled in preview>
Ireland900996<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NAMENDA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/046United Kingdom<disabled>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
02C/035Belgium<disabled>PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
90025-6Sweden<disabled>PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
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