Endo Pharmaceuticals Inc., a subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that they have filed a lawsuit against Actavis South Atlantic LLC in the United States District Court for the District of New Jersey in connection with Actavis's Abbreviated New Drug Application (ANDA) for OPANA(R) ER (oxymorphone HCl) extended-release tablets CII.
The lawsuit is in response to Actavis's notice to Endo and Penwest, announced on February 15, 2008, advising of the filing by Actavis of an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII. 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 U.S. Patent No. 5,958,456, which is one of these Orange Book-listed patents.
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 expires
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