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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-five suppliers are listed for this compound. There are two 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

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*PED► subscribe ► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 2010RXNo8,362,085*PED► subscribeY► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYes8,039,009*PED► subscribeY► subscribe
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Expired Patents for Tradename: NAMENDA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMENDA
memantine hydrochloride
SOLUTION;ORAL021627-001Apr 18, 20055,614,560► subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-001Oct 16, 20035,061,703*PED► subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-002Oct 16, 20035,061,703*PED► subscribe
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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
JapanH02292214► subscribe
Hungary215592► subscribe
Denmark173356► subscribe
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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
988Luxembourg► subscribe
02C/035Belgium► subscribePRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
C/GB02/046United Kingdom► subscribePRODUCT 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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