Orexo commences patent infringement litigation against Actavis for their generic versions of Suboxone® and Subutex® tablets in the US

Uppsala, Sweden – March 1, 2017 – Orexo AB (publ.) today announced that it 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.

For more information, please contact:

Orexo AB (publ.)
Nikolaj Sørensen, CEO and President Henrik Juuel, EVP and CFO
Tel: +46 (0)18 780 88 00 Tel: +46 (0)18 780 88 00
Email: ir@orexo.com Email: ir@orexo.com

About Orexo
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. R&D is focusing on reformulation of known substances to new improved products that meet great unmet medical needs by using its patented proprietary technologies. Orexo’s share is listed on Nasdaq Stockholm Exchange Mid Cap (STO:ORX) and is available as ADRs on OTCQX (ORXOY) in the US. Orexo’s global headquarters and R&D are based in Uppsala, Sweden.

For more information about Orexo, please visit www.orexo.com or follow us on Twitter or LinkedIn. For further information about Zubsolv® in the US, please visit www.zubsolv.com.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00am CET on March 1, 2017. 

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