Oxymorphone hydrochloride extended-release tablets: Endo filed lawsuit against Actavis

Endo Pharma announced that they have filed a lawsuit against Actavis in the US District Court of New Jersey in connection with Actavis's Abbreviated New Drug Application (ANDA) for OPANA(R) ER (oxymorphone HCl) extended-release tablets. The lawsuit is in response to Actavis's notice to Endo and Penwest, send on February 15, 2008, regarding the filing by Actavis an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release. Actavis's Paragraph IV certification notice refers to four Penwest patents listed in the FDA's Orange Book, which patents cover the formulation of OPANA ER. The complaint filed today alleges infringement of US5958456. OPANA ER has been granted new dosage form regulatory exclusivity that prevents the FDA from approving any ANDA for a generic version of OPANA ER for launch prior to June 22, 2009, the date such regulatory exclusivity