Orexo AB (publ.), a specialty pharmaceutical company, has filed a patent infringement action in United States District Court for the District of Delaware against Actavis Elizabeth LLC, Actavis Pharma, Inc., and their parent company Teva (collectively “Actavis”). Orexo alleges that Actavis’s generic versions of Suboxone and Subutex tablets infringe Orexo’s US Patent No. 8,454,996 (the ‘996 patent).

On November 15, 2016, the Delaware District Court held Orexo’s ’996 patent (which expires in September 2019) valid and infringed by Actavis’s generic versions of Zubsolv. Actavis did not appeal the district court’s decision regarding the ‘996 patent. Orexo believes Actavis’s generic versions of Suboxone and Subutex tablets, which like Zubsolv include buprenorphine as an active ingredient, also infringe Orexo’s ’996 patent.

Actavis’s generic version of Suboxone was approved by the FDA in February 2013 and their generic version of Subutex in February 2015. Orexo is seeking compensation for damages caused by Actavis’s infringement of the ‘996 patent since approval of these two products.      

“Considering the favorable outcome from the Zubsolv litigation regarding the ‘996 patent, we find we have a strong position in the new litigation process against Actavis,” says Nikolaj Sørensen, CEO and president of Orexo AB.

Orexo is a specialty pharmaceutical company commercializing its proprietary product Zubsolv for treatment of opioid dependence in the US. Zubsolv is an advanced formulation of buprenorphine and naloxone using Orexo’s unique knowledge and expertise in sublingual drug delivery.