A U.S. court has issued a temporary restraining order against Dr. Reddy’s Laboratories with respect to further sales and commercialisation of Buprenorphine and Naloxone sublingual film within the U.S.
The order of the U.S. District Court for the District of New Jersey pertains to a current patent litigation, and comes after Dr. Reddy’s got the USFDA’s approval for a generic version of Indivior Plc.’s Suboxone ((buprenorphine and naloxone) sublingual film that is used to treat opioid dependence.
The Hyderabad firm said following the introduction of the generic version, the court “received and reviewed an emergency application from the plaintiffs... [and] issued the order against Dr. Reddy’s. The order does not include a prohibition on commercial manufacturing of the product.
Dr. Reddy’s asserted it remained “confident in its legal positions on this patent [U.S. Patent No.9,931,305] and believes it will prevail on the issues raised with respect to the application for injunction.”
The plaintiffs will be required to post a bond or other security totalling $18 million to satisfy any losses or damages incurred by Dr. Reddy’s during the period of the temporary restraining order. The court has scheduled an expedited hearing of the preliminary injunction for June 28 and a ruling is expected soon thereafter,” Dr.Reddy’s said.
Indivior said the temporary restraining order compels “Dr. Reddy’s to immediately cease its launch activities related to Suboxone film”. The British drugmaker said it would seek to extend the cessation of launch activities by DRL pending the outcome of the recently filed litigation against DRL related to the ‘305 patent’.
“We will continue to pursue all legal avenues against Dr. Reddy’s to protect our Suboxone film patent estate,” CEO Shaun Thaxter said.