London, UK (PRWEB) July 24, 2014
Memantine was initially developed by Merz to treat Alzheimer’s disease (AD) and was first marketed in Germany under the brand name Akatinol; it was later licensed to Lundbeck Ltd. in Europe and other nations as Ebixa and in the USA to Forest Labs as Namenda. Lundbeck reported the sales of Ebixa of USD 420 million in 2013. In the US, Forest reported Namenda sales of USD 1.5 billion during 2014.
Patent protection expiry in Canada, Australia and the European region has increased the competition from generic drugs in the market. The lack of a sustained release formulation in the region has made Lundbeck more susceptible to generic erosion. In the USA, use patent protection via ‘703 is set to expire in April 2015, which may be awarded 6 month paediatric market exclusivity and may possibly further extend the expiry till October 2015. Lifecycle management carried out by Forest at such a late stage to switch to the extended release (XR) formulation by discontinuing their manufacturing and marketing of the immediate-release (IR) tablets, extension of indication to treat autism in the paediatric population, and novel fixed-dose combination of Donepezil and Memantine may see Forest grab some share of the US market beyond the expiry of the ‘703. Generic competitors have created and patented their own technology for XR formulations of Memantine in an effort to outsmart innovator patents. Additionally, generic competitors have filed Paragraph IV certifications to Orange Book listed patents in their abbreviated new drug application (ANDA) applications for an equivalent XR Memantine formulation. Though, they are unlikely to get FDA approval till at least June 2016 or conclusion of patent infringement litigation.
The research report offers unrivalled knowledge of the patent landscape for Merz’s N-methyl-D-aspartate antagonist Memantine across over 80 countries of the globe, outlines the main factors having a bearing on the potential launch of generic versions of the drug, and presents accurate categorisation and interpretation – all delivered by an easy-to-use online interface.