Orexo Settles Abstral® US Patent Litigation with Actavis

Uppsala, Sweden – October 27, 2015 – Orexo AB (publ) today announced that it has
entered into a settlement and license agreement with Actavis Laboratories FL,
Inc. (“Actavis”) to settle the patent litigation regarding Abstral® in the U.S.

The agreement settles the patent infringement litigation commenced early this
year by Orexo following Actavis’ filing of an Abbreviated New Drug Application
(“ANDA”) seeking approval to market generic versions of Abstral® (fentanyl)
sublingual tablets in the U.S. prior to the expiration of Orexo’s patents listed
in FDA’s Orange Book for Abstral®.

The agreement allows Actavis to enter the market in June 2018, or earlier under
certain conditions. Orexo’s patents listed in FDA’s Orange Book for Abstral®
expire in September 2019.

For further information, please contact:
Nikolaj Sørensen, President and CEO, Orexo AB
Tel: +46 703 50 78 88, E-mail: ir@orexo.com

About Abstral®
Abstral is the leading fast-acting fentanyl product in EU intended for treatment
of breakthrough pain in cancer patients. Abstral employs Orexo’s proprietary
sublingual delivery technology (under the tongue). After the product development
Abstral was out-licensed to Kyowa Hakko Kirin Co., Ltd and the European
subsidiary ProStrakan Group plc, which still holds the rights in the EU and
Japan, whereas Galena Biopharma Inc holds the rights for Abstral in the US.

For information about Abstral, please visit www.abstral.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 please visit www.orexo.com and www.zubsolv.

Orexo AB (publ) discloses the information provided herein pursuant to the
Financial Instruments Trading Act and/or the Securities Markets Act. The
information was submitted for publication at 08:30 am CET on October 27, 2015.