Orexo announced that Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc. (collectively "Sun") have appealed the patent litigation decision issued by the US District Court for the District of New Jersey relating to Orexo's patents protecting ZUBSOLV® (buprenorphine and naloxone) sublingual tablets (CIII) in the US.
The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®. On June 30, 2023, the district court ruled in favor of Orexo and found that its patents are valid and infringed by Sun, thereby prohibiting Sun from launching its generic ZUBSOLV® tablets until September 2032. Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.