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Details for Patent: 8,338,486

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Which drugs does patent 8,338,486 protect, and when does it expire?

Patent 8,338,486 protects NAMZARIC and is included in one NDA.

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

Summary for Patent: 8,338,486

Title:	Methods for the treatment of CNS-related conditions
Abstract:	The invention provides methods for administering extended release memantine in combination with immediate release donepezil to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt thereof in combination with donepezil is administered to a patient suffering from a neurological condition, such as Alzheimer's disease, Parkinson's disease or dementia. The extended release form of memantine achieves particular pharmacokinetic criteria such as change in plasma concentration of memantine over time and ratio of maximum memantine plasma concentration to mean memantine plasma concentration.
Inventor(s):	Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Meyerson; Laurence R. (Las Vegas, NV)
Assignee:	Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Application Number:	13/536,763
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,338,486
Patent Claim Types: see list of patent claims	Use; Dosage form;

Drugs Protected by US Patent 8,338,486

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	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016		RX	Yes	No						MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Forest Labs Llc	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014	AB	RX	Yes	No						MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Forest Labs Llc	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No						MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Forest Labs Llc	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014	AB	RX	Yes	Yes						MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE

Non-Orange Book US Patents Family Members for Patent 8,338,486

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
8,058,291	Methods and compositions for the treatment of CNS-related conditions
8,173,708	Method and composition for administering an NMDA receptor antagonist to a subject
8,283,379	Methods and compositions for the treatment of CNS-related conditions
2,012,045,508

International Family Members for US Patent 8,338,486

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