Barr confirms Namenda patent challenge

Generics firm Barr Laboratories has initiated a challenge of the patent listed by fellow USA-based Forest Laboratories, In connection with its Namenda (memantine HCl) tablets, 5mg and 10mg.

Barr filed an Abbreviated New Drug Application containing a Paragraph IV certification for a generic Namenda product with the Food & Drug Administration on October 16, 2007, the first date the FDA could accept a filing. Following receipt of the notice from the FDA that Barr's ANDA had been accepted, the company notified the patent holder.

On January 10, 2008, Forest, Merz Pharma GmbH & Co. KgaA and Merz Pharmaceuticals GmbH filed suit in the US District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.