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NAMENDA XR Drug Profile

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

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

The generic ingredient in NAMENDA XR 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 XR

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: NAMENDA XR

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, 2010RXYes8,173,708*PED► subscribeY► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYes8,598,233*PED► subscribeY► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYes8,283,379*PED► subscribeY► subscribe
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Expired Patents for Tradename: NAMENDA XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 20105,061,703*PED► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 20105,061,703*PED► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 20105,061,703*PED► subscribe
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Paragraph IV activity for: NAMENDA XR

Drugname Dosage Strength RLD Submissiondate
memantine hydrochlorideExtended-release Capsules7 mg, 14 mg, 21 mg, and 28 mgNamenda XR8/16/2013
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

International Patent Family for Tradename: NAMENDA XR

Country Document Number Estimated Expiration
Denmark91690► subscribe
Austria94384► subscribe
Luxembourg90988► 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 XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
02C/035Belgium► subscribePRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
988Luxembourg► subscribe
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