US District Court rules in favour of Orexo in patent litigation against Sun Pharma on Zubsolv patent

The district court's decision concludes the litigation that was initiated in September 2020 as a response to Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV. As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV tablets until September 2032, and Orexo's patent protection remain unchanged. ZUBSOLV is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Nikolaj Sørensen, President and CEO of Orexo AB, said: "I am very pleased that me and my team in both the US and Sweden, yet another time have received confirmation about the strength of our patents protecting the innovation and technology behind ZUBSOLV. Since its launch in the US in 2013, ZUBSOLV has generated more than SEK 4.7 billion in net revenues and will continue to be an important cash generator. I want to thank all our shareholders and, most importantly, the employees for their continued support and commitment during the last three years. Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients."

The American market for buprenorphine/ naloxone products is the largest, where Orexo commercializes its product ZUBSOLV for treatment of opioid use disorder.