NY firm sues Aurobindo for Alzheimer’s generic drug
Jul 01 2014 , Hyderabad
The case filed on June 27 alleges infringement of patent No. 5,061,703 titled 'Adamantane derivatives in the prevention and treatment of cerebral ischemia' which was granted by the US patent and trademark office in June 2007. While Frankfurt-based Merz pharma is the owner of the patent, the exclusive licensee is Forest Laboratories.
Aurobindo had submitted an abbreviated new drug application (ANDA) to FDA seeking approval to make and market a generic version of the drug around mid-May. The 703 patent expires in April 2015.
Forest Laboratories has sought Delaware district court’s intervention to prevent Aurobindo selling this drug before the expiry of the patent, including exclusivities and extensions. It also wants monetary relief from the Indian company. Reports suggest that in the last quarter of 2013, Namenda had sales of $379.2 million, while Namenda XR logged $37.8 million.
The Forest website says the company plans to discontinue the sale of Namenda 5 mg and 10 mg tablets in fall 2014. “This action is not due to any safety or efficacy issue related to Namenda tablets. The oral solution of Namenda will continue to be available, along with Namenda XR (memantine HCl) extended-release capsules. This drug is for the treatment of moderate to severe dementia of the Alzheimer’s type. Namenda, a twice daily immediate release formulation, was approved in October 2003."
Prior to this, Forest had sued Sun Pharma Global, Teva Pharmaceuticals, Wockhardt Bio AG for infringement of 703 and other related patents. As some of the generics makers have a licence to sell the drug three months prior to the expiry, the company expects the copycat version to hit the market in July 2015.