Orexo AB announces that Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc 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 favour 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.
Nikolaj Sorensen, President and CEO of Orexo AB, said: “The decision from the District Court was very well motivated and clearly outlined the significant shortfalls in SUN’s non-infringement and invalidity claims against the ZUBSOLV® patents. We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion.”
ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032. An appeal process is expected to take 18 months and will be related to legal costs in the range of SEK 5-15 million.
