Orexo announced that the US District Court for the District of New Jersey ruled in favor of Orexo in its patent litigation against Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc. (collectively "Sun") regarding ZUBSOLV® (buprenorphine and naloxone) sublingual tablets (CIII) in the US. The district court found that Orexo´s patents are valid and infringed by Sun.
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 remains unchanged. ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.