July 30, 2008
Endo and Penwest File Patent Infringement Suit Against Impax
Endo Pharmaceuticals and Penwest Pharmaceuticals have filed suit against Impax Laboratories for patent infringement based on Impax's amendment to its existing abbreviated new drug application for oxymorphone hydrochloride extended-release tablets CII, generic of Opana ER, adding new 7.5mg, 15mg and 30mg strengths.
In connection with this amendment, Impax provided a notice to Endo and Penwest that its submission includes a Paragraph IV certification stating its product does not infringe any valid and enforceable patent.
The company also said that it will continue to vigorously defend this lawsuit.