Endo announces US District Court ruling upholding Opana ER intellectual property
The ruling confirms the Court's prior injunction against the manufacture or sale of the generic version of non-crush-resistant Opana ER.
Endo International has announced that the US District Court for the Southern District of New York has issued an order upholding its August 2015 ruling in Endo's favour and confirming the Court's prior injunction against the manufacture or sale of the generic version of non-crush-resistant Opana ER currently offered by Actavis, the US generics business of Allergan, and the additional approved but not yet marketed generic version of the product developed by Roxane Laboratories.
In December 2012, Endo filed a patent infringement complaint against Actavis for patent infringement based on Actavis' sale of a non-crush-resistant generic version of Opana ER. In 2013, Endo filed suits against the following additional applicants for non-crush-resistant Opana ER: Par Pharmaceutical (now a subsidiary of Endo), Teva Pharmaceuticals, Mallinckrodt LLC, Sandoz, Roxane Laboratories and Ranbaxy Laboratories. The suits against Par Pharmaceutical and Mallinckrodt LLC were dismissed pursuant to settlements, and the suits against Teva Pharmaceuticals and Sandoz were dismissed based on those companies' demonstration to Endo that they are not seeking FDA approval to sell generic versions of non-crush-resistant Opana ER prior to the expiration of Endo's patents.
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