Orexo commences patent infringement litigation against Sun Pharmaceutical.

Orexo AB (publ.), announces it has filed a patent infringement action in the United States District Court for the District of New Jersey, against Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc. (collectively “Sun”). The lawsuit was filed in response to an Abbreviated New Drug Application (“ANDA”) filed by Sun with the FDA. In its ANDA, Sun seeks to market and sell generic versions of Orexo’s Zubsolv products, (buprenorphine and naloxone) sublingual tablets (CIII), in the US prior to expiration of the patents listed in FDA’s Orange Book. In the lawsuit, Orexo asserts US Patent Nos. 8,470,361; 8,658,198; 8,940,330; 9,259,421 and 9,439,900 against Sun. The patents have expiration dates ranging from December 2027 to September 2032. Since Orexo timely filed a lawsuit against Sun, FDA is statutorily precluded from approving Sun’s ANDA for 30 months, or until a district court decision finds the patents to be invalid or not infringed, whichever occurs first. The 30-month stay period began as of the date Orexo received the notice letter from Sun advising Orexo of their ANDA filing.