americanpharmaceuticalreviewJanuary 14, 2019
Tag: actavis , Orexo , Zubsolv , U.S. Patent
Orexo announces that the United States District Court for the District of Delaware has issued a final, non-appealable judgement that Actavis's generic Zubsolv products infringe Orexo's U.S. patent No. 8,940,330. The judgement will prevent Actavis from commercializing their infringing generic Zubsolv products in the U.S. until after September 18, 2032.
The infringement judgement now issued by the District Court follows from the decision from the U.S. Court of Appeals for the Federal Circuit on September 10, 2018, that the '330 patent is valid. The infringement judgement involves all dosage strengths of Actavis's generic Zubsolv products. As a result of the favorable infringement judgement, Orexo's lawsuits against Actavis involving U.S. Patent Nos. 9,259,421 and 9,439,900, also protecting Zubsolv in the US until September 18, 2032, have been withdrawn.
This infringement judgement does not relate to the litigation against Actavis where Orexo alleges that Actavis's generic versions of Suboxone and Subutex tablets infringe Orexo's U.S. Patent No. 8,454,996.
"Although expected, I am very pleased that we now have a final judgement preventing Actavis from commercializing its generic Zubsolv products in the US until September 2032. It has been an extraordinarily long process and I want to thank my team, the Board of Directors and the shareholders who never doubted we would succeed. We are now looking forward to focus on expanding our commercial platform to leverage scale and increase revenues," said Nikolaj Sørensen, President and CEO, Orexo AB.
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