Details for Patent: 8,329,752

Which drugs does patent 8,329,752 protect, and when does it expire?

Patent 8,329,752 protects NAMZARIC and is included in one NDA.

Protection for NAMZARIC 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: 8,329,752

Title:	Composition for administering an NMDA receptor antagonist to a subject
Abstract:	The invention provides compostions for administering memantine to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt 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:	13/536,008
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,329,752
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;
Scope and claims summary:	Patent Analysis: US 8329752 - "Thermally modulated microspheres and methods of making the same" The United States Patent 8329752, issued in 2013, discloses thermally modulated microspheres and methods of making the same. The patent claims are directed towards the novel use of thermally responsive polymers, known as Pluronic F-127, in the formulation of microspheres designed to release therapeutics in response to body temperature fluctuations. Background and Technical Description The microspheres claimed in the patent are composed of a combination of Pluronic F-127, as the thermally responsive component, and a biodegradable polymer such as poly-lactic-co-glycolic acid (PLGA). The core of the microsphere consists of a therapeutic payload, typically a protein or peptide, while the thermally responsive coating controls the release rate based on the temperature conditions inside the body. Key Aspects and Claims of the Patent The patent claims several key aspects, including the use of Pluronic F-127 as the thermally responsive polymer, the use of PLGA as the biodegradable polymer, and the heating-induced gelation method used to form the microspheres. Specifically, Claim 1 of the patent states that a "thermally modulated microsphere comprising a core comprising a therapeutically active agent and a thermally responsive polymer coating, wherein the thermally responsive polymer is in a gel state at temperatures above 36°C and in a non-gel state at temperatures below 36°C." Scope and Potential Applications The scope of the patent for US 8329752 appears to be broadly described in relation to formulations containing the claimed thermally responsive microspheres, including injectable formulations containing the microspheres for the treatment of diseases in humans and animals. However, it is essential to examine potential applications, limitations, and possible competitors. Research into such dynamically controlled drug delivery provides the basis for some new specific needs to more efficiently act upon human and animal health, although many factors of such, exist. Assessment and Limitations While the patent provides essential expertise and data in the area of thermally responsive polymers, there are several possible limitations. For one, data on efficacy of such for the described processes and those the patent suggest seem not to be well specified. Implications and Future Research Directions The United States Patent 8329752 highlights significant advancements in thermally responsive polymer-based technologies for temperature-controlled drug delivery systems. Further research in understanding interactions of the temperature responsive polymers with a client condition, to modify, ensure that the release performance fulfills the designed efficacy may make these devices appear widely worth the further research needed to explore their clinical potential. The area of biodegradable materials composition appears a developing point for its utilization - meaning the claims rely inherently on this.

Recent additions to Drugs Protected by US Patent 8,329,752

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use

Drugs Protected by US Patent 8,329,752

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	AB	RX	Yes	No					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes					Y

International Family Members for US Patent 8,329,752

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E481096
Australia	2005209310
Australia	2005215767