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Details for Patent: 8,598,233

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Which drugs does patent 8,598,233 protect, and when does it expire?

Patent 8,598,233 protects NAMENDA XR and NAMZARIC and is included in two NDAs.

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

This patent has fifty-seven patent family members in eighteen countries.

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;

Drugs Protected by US Patent 8,598,233

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Forest Labs Llc	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	AB	RX	Yes	Yes					Y
Forest Labs Llc	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016		RX	Yes	No					Y
Forest Labs Llc	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	AB	RX	Yes	No					Y
Forest Labs Llc	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No					Y

Non-Orange Book US Patents Family Members for Patent 8,598,233

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,619,007	Method and composition for administering an NMDA receptor antagonist to a subject
8,058,291	Methods and compositions for the treatment of CNS-related conditions
8,168,209	Method and composition for administering an NMDA receptor antagonist to a subject
2,012,045,508

International Patents Family Members for US Patent 8,598,233

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	481096
Australia	2005209310
Australia	2005215767
Australia	2005215775