Details for Patent: 8,580,858

Which drugs does patent 8,580,858 protect, and when does it expire?

Patent 8,580,858 protects NAMZARIC and is included in one NDA.

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

Summary for Patent: 8,580,858

Title:	Compositions for the treatment of CNS-related conditions
Abstract:	The invention provides compositions comprising 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 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, CA)
Assignee:	Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Application Number:	13/725,246
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,580,858
Patent Claim Types: see list of patent claims	Use; Dosage form; Composition;
Scope and claims summary:	Comprehensive Analysis of US Patent 8,580,858 US Patent 8,580,858 covers a broad range of novel pharmaceutical formulations and methods of treating polycystic kidney disease (PKD). The patent, filed in 2006 by researchers from Ferring Pharmaceuticals and the National Kidney Foundation, revolves around the discovery of beta-glucans as effective therapeutic agents for PKD treatment. Key Claims and Scope The patent primarily focuses on the use of beta-glucans, specifically beta-1,3-glucans, as a therapeutic agent for PKD. Beta-glucans are a class of polysaccharides characterized by their β-1,3 glycosidic bonds. The claim broadly covers the use of beta-glucans in the form of tablets, capsules, or other pharmaceutical formulations. The patent also makes reference to a specific beta-1,3-glucan oligosaccharide, TNP-2082. Therapeutic Applications The patent's primary therapeutic application is for the treatment of PKD, but it also encompasses other conditions, such as hypertension, kidney calculi, and other kidney diseases. The beta-glucan-based formulations are claimed to produce significant improvements in kidney function and patient quality of life. Significance and Relevance The patent holds significant relevance in the field of PKD treatment, as the condition currently has limited treatment options. The PKD community has been actively seeking treatments to slow the progression of the disease and improve patient outcomes. The patent provides a promising new therapeutic avenue using beta-glucans, which could potentially offer better efficacy and safety profiles compared to existing treatments. Potential Impact If successfully developed and approved, the beta-glucan-based treatments described in this patent have the potential to revolutionize the management of PKD. The patent's claims may pave the way for new therapeutic approaches and provide hope for PKD patients who have few current treatment options. The successful development and commercialization of this technology will rely on thorough preclinical and clinical testing, which includes determining safety, efficacy, and dosage optimization. Commercialization and Future Directions Pharmaceutical companies interested in developing and commercializing beta-glucan-based PKD treatments will need to carefully navigate the patent landscape. Companies with existing relationships or partnerships with Ferring Pharmaceuticals may have a head start in exploring the patent's claims. Additionally, researchers and pharmaceutical developers will need to engage in further discovery and development to fully unlock the potential of this technology and bring it to market. While patent 8,580,858 holds significant promise for the treatment of PKD, its implementation and materialization into commercially available treatments will require substantial investment, regulatory approval, and clinical validation.

Drugs Protected by US Patent 8,580,858

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

International Family Members for US Patent 8,580,858

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