Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that on February 14, 2008, they received a notice from Actavis South Atlantic LLC advising of the filing by Actavis of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII.
The Actavis Paragraph IV certification notice refers to Penwest's orange book listed patents
US5128143-Product patent
US5662933- Controlled release formulation
US5958456- Controlled release formulation
US7276250-Sustained release formulations
In addition to these patents, oxymorphone hydrochloride has a new dosage form (NDA) exclusivity that prevents final approval of any ANDA by the FDA until the exclusivity expires on June 22, 2009. Endo and Penwest are currently reviewing the details of this notice from Actavis. Endo and Penwest note that they intend to pursue all available legal and regulatory avenues in defense of oxymorphone hydrochloride ER, including enforcement of their intellectual property rights and approved labeling. As previously disclosed, Endo and Penwest also have been notified by IMPAX Laboratories Inc. of its filing of an ANDA containing Paragraph IV certifications for oxymorphone hydrochloride ER in late 2007. Patent infringement suits against IMPAX are pending in the U.S. District Court for the District of Delaware.
The Actavis Paragraph IV certification notice refers to Penwest's orange book listed patents
US5128143-Product patent
US5662933- Controlled release formulation
US5958456- Controlled release formulation
US7276250-Sustained release formulations
In addition to these patents, oxymorphone hydrochloride has a new dosage form (NDA) exclusivity that prevents final approval of any ANDA by the FDA until the exclusivity expires on June 22, 2009. Endo and Penwest are currently reviewing the details of this notice from Actavis. Endo and Penwest note that they intend to pursue all available legal and regulatory avenues in defense of oxymorphone hydrochloride ER, including enforcement of their intellectual property rights and approved labeling. As previously disclosed, Endo and Penwest also have been notified by IMPAX Laboratories Inc. of its filing of an ANDA containing Paragraph IV certifications for oxymorphone hydrochloride ER in late 2007. Patent infringement suits against IMPAX are pending in the U.S. District Court for the District of Delaware.
