Pharma Business - August 12, 2020
Orexo receives paragraph IV Notice Letter in the US
Orexo has received a “paragraph IV” patent certification notice from Sun Pharmaceutical Industries Limited. The Notice Letter advises Orexo of Sun’s filing of an Abbreviated New Drug Application with the US Food and Drug Administration (FDA) seeking approval of generic versions of ZUBSOLV before the expiration of Orexo’s patents listed in the Orange Book. Orexo […]
Agreement - November 28, 2019
Orexo acquires US rights to commercialize vorvida
Orexo has acquired the exclusive US rights to vorvida, a digital therapy for the treatment of Alcohol Use Disorder (AUD), from GAIA. This news follows an earlier agreement with GAIA in August 2019, for the exclusive global commercial rights to OXD01, a new digital therapy being developed for the treatment of Opioid Use Disorder (OUD). […]
Pharma Business - June 2, 2017
Orexo receives USD 2.5 million milestone payment
Orexo announces that the OX-CLI project has advanced into clinical phase I triggering a milestone payment of USD 2.5 million´(approx. SEK 23 million) from AstraZeneca. OX-CLI is a Leukotriene (LT) C4 Synthase inhibitor program directed to develop a novel treatment of respiratory disorders such as asthma and COPD. AstraZeneca acquired the compound from Orexo in […]
Intellectual Property - March 2, 2017
Orexo enters patent infringement litigation against Actavis
Orexo 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. 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 […]
Pharma Business - February 21, 2017
Orexo completes bond buyback program
Orexo AB announces that it has successfully completed a limited bond buyback program and in total purchased Orexo corporate bonds in the market with a nominal value of MSEK 59. The program was initiated on February 8, 2017, and completed by February 17, 2017. After the purchase Orexo owns own bonds with a nominal value […]
Regulatory compliance - December 14, 2016
Orexo appeal Zubsolv US district court decision
Orexo has appealed the decision rendered by the United States District Court for the District of Delaware on November 15, 2016 regarding the validity of Orexo’s US Patent No. 8,940,330 protecting Zubsolv. The decision was rendered in the patent litigation regarding Actavis’s generic Zubsolv 1.4/0.36 mg and 5.7/1.4 mg buprenorphine/naloxone products, and Orexo’s US Patent […]
