Barr has filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic version of Amrix with the FDA, and following receipt of the notice from the FDA that Barr’s ANDA had been accepted for filing, Barr notified the new drug application holder and patent owner.
On November 26, 2008, Eurand, Cephalon, and Anesta have filed suit in the US District Court 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.