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NAMENDA XR Drug Profile

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Which patents cover Namenda Xr, and what substitute generic drugs are available?

Namenda Xr is a drug marketed by Forest Labs Llc and is included in one NDA. There are seven patents protecting this drug and four Paragraph IV challenges.

The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Thirty-six 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:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list69
Clinical Trials: see list18
Patent Applications: see list1,165
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NAMENDA XR at DailyMed

Pharmacology for Tradename: NAMENDA XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYesYes► Subscribe► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYesYes8,173,708*PED► SubscribeY► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYesYes► Subscribe► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYesYes8,283,379*PED► SubscribeY► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 2010RXYesNo8,039,009*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;ORAL022525-004Jun 21, 20105,061,703*PED► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-002Jun 21, 20105,061,703*PED► Subscribe
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
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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
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