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news.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.
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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.