Orexo has filed a patent infringement action in the US District Court for the District of Delaware, against Actavis Elizabeth LLC and its parent company Actavis.
The lawsuit was filed in response to an Abbreviated New Drug Application (“ANDA”) filed by Actavis. In its application, Actavis seeks to market and sell generic versions of Orexo’s patented ZUBSOLV (buprenorphine and naloxone) products in the U.S. prior to the expiration of Orexo’s U.S. Patents listed in the FDA’s Orange Book. The listed patents in the Orange Book are U.S. patents, 8,454,996 (expiration September 2019), 8,470,361 (expiration October 2029) and 8,658,198 (expiration December 2027), according to a statement from Orexo.
Since Orexo AB timely initiated a lawsuit against Actavis, the FDA is statutorily precluded from approving Actavis’ ANDA for 30 months, or until a district court decision finding the patents invalid or not infringed, whichever occurs earlier. The 30 month stay period began as of the date Orexo AB received the Notice Letter from Actavis that notified Orexo of the ANDA filing.
“The ZUBSOLV products have a significant market potential and the ANDA filing of generic versions could be expected. Orexo has since the development of the ZUBSOLV products was initiated, worked with leading internal and external experts to ensure a solid patent portfolio to protect the products. We have full confidence in our patents listed in FDAs Orange Book today and intend to defend our rights vigorously,” said Nikolaj Sørensen, Orexo’s president and CEO.