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Details for Patent: 8,598,233

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Patent 8,598,233 protects NAMENDA XR and NAMZARIC and is included in two NDAs. There have been zero Paragraph IV challenges on Namzaric and Namenda XR There are two tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for NAMENDA XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 8,598,233

Title:Method for administering an NMDA receptor antagonist to a subject
Abstract: Compositions and methods for administering memantine to a subject are provided. In particular, a solid pharmaceutical composition in a unit dosage form for once daily oral administration is provided. The compositions comprises an extended release formulation of 22.5 mg to 33.75 mg memantine, or a pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by a change in memantine concentration as a function of time (dC/dT) that is less than 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0 hours to 6 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study. Methods of treating dementia, in particular Alzheimer's diseases, using the compositions are provided.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Meyerson; Laurence R. (Las Vegas, NV)
Assignee: Adamas Pharmacueticals, Inc. (Emeryville, CA)
Application Number:13/751,876
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 10th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Forest Labs Llc
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010RXYes8,598,233*PEDMay 22, 2026Y
Forest Labs Llc
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-003Jul 18, 2016RXNo8,598,233*PEDMay 22, 2026Y
Forest Labs Llc
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-001Dec 23, 2014RXNo8,598,233*PEDMay 22, 2026Y
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