Actavis confirms that Actavis Elizabeth L.L.C. has initiated a challenge of the patent listed in connection with King Pharmaceuticals’ Avinza® (morphine sulfate extended-release capsules). Actavis believes that it is the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avinza.
Actavis filed its ANDA for Avinza containing the paragraph IV certification with the US Food and Drug Administration (FDA) in June 2007. Upon receiving filing acceptance from the FDA, Actavis Elizabeth L.L.C. notified King Pharmaceuticals and the patent owner. On 10 September, 2007, King issued a press release that confirmed that it received Actavis Elizabeth's paragraph IV certification notice and that it intends to enforce its patent.
Avinza® capsules are a modified-release formulation of morphine sulfate intended for once daily administration indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. The product had annual sales of approximately US$169 million for a 12 month period, ending June 2007, according to IMS Health data.
More information about Actavis in the United States can be found at www.actavis.us.