Endo Announces US District Court Ruling Upholding Opana ER Intellectual Property

Endo International has announced that the US District Court for the Southern District of New York has issued a ruling upholding two Endo patents covering Opana ER, the company's opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The ruling also determined that Endo's patents had been infringed by all of the defendants. As a result, it is expected that the generic version of non-crush-resistant Opana ER currently sold by Actavis, the US generics business of Allergan, Inc., will be removed from the market and additional approved but not yet marketed generic versions of the product developed by other generic companies will not be launched in the near term.

"Endo has long been dedicated to vigorously asserting and defending our patents for Opana ER," said Rajiv De Silva, President and CEO of Endo. "We are very happy with today's outcome and are reviewing the ruling in greater detail to determine its long-term impact. We remain committed to advancing Opana ER and to making it available to patients for responsible and appropriate use."

In December 2012, Endo filed a patent infringement complaint against Actavis in US District Court for the Southern District of New York for patent infringement based on Actavis' sale of a non-crush-resistant generic version of Opana ER. In 2013, Endo filed similar suits in the US District Court for the Southern District of New York against the following additional applicants for non-crush-resistant Opana ER: Par Pharmaceutical, Teva Pharmaceuticals, Mallinckrodt LLC, Sandoz, Roxane and Ranbaxy. The suits against Par Pharmaceutical and Mallinckrodt LLC have been dismissed pursuant to settlements and the suits against Teva Pharmaceuticals and Sandoz have been dismissed based on those companies' demonstration to Endo that they do not intend to pursue an ANDA for non-crush-resistant Opana ER.