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Actavis infringes Orexo’s long term Zubsolv® US patent ´330

Uppsala, Sweden – January 11, 2019 – Orexo AB (publ.), the fully integrated specialty pharmaceutical company addressing opioid addiction and pain, today 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 US patent No. 8,940,330. The judgement will prevent Actavis from commercializing their infringing generic Zubsolv products in the US until after September 18, 2032.

The infringement judgement now issued by the District Court follows from the decision from the US 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 favourable infringement judgement, Orexo’s lawsuits against Actavis involving US Patent Nos. 9,259,421 and 9,439,900, also protecting Zubsolv in the US until September 18, 2032, have been withdrawn.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 US 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.

For further information, please contact:

Orexo AB (publ.)
Nikolaj Sørensen, President and CEO Lena Wange, IR and Communications Manager
Tel: +46 (0)18 780 88 00 Tel: +46 (0)18 780 88 00
E-mail: moc.o1553487962xero@1553487962ri1553487962 E-mail: moc.o1553487962xero@1553487962ri1553487962

About Orexo

Orexo develops improved pharmaceuticals based on innovative drug delivery technologies. The focus is primarily on opioid dependence and pain but the aim is to address therapeutic areas where our competence and technologies can create value. The main market today is the US market for the treatment of opioid dependence where the product Zubsolv is commercialized by Orexo. Other products are commercialized by license partners, including Zubsolv® in markets outside of the US. Total net sales for 2016 amounted to SEK 705.9 million and the number of employees was 102. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) index and is available as ADRs on OTCQX (ORXOY) in the US. The head office, where also research and development is performed, is located in Uppsala, Sweden.

For more information about Orexo please visit, www.orexo.com. You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn and YouTube.

The information was submitted for publication at 8:00 am CET on January 11, 2019


Source: Orexo