US Court of Appeals finds in favour of Dr Reddy's Laboratories in buprenorphine and naloxone sublingual film patent case
22 November 2018 -

India-based Dr Reddy's Laboratories has received a favourable decision from the US Court of Appeals for the Federal Circuit, which concluded that Indivior had not shown that it was likely to succeed on the merits of its infringement case regarding US Patent No 9,931,305, it was reported yesterday.

This decision vacates the District Court's preliminary injunction that had prohibited the company from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. As a result of the ruling, the company will resume its launch activities as soon as permitted.

Following US FDA approval in June, Dr Reddy's began commercialisation of Buprenorphine and Naloxone Sublingual Film, in four strengths including 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg, for sale in the US market. Sales and commercialisation activities were subsequently halted as a result of a court-imposed temporary restraining order (TRO) against Dr Reddy's.

Dr Reddy's spokesperson said, 'We are pleased with the decision of the appellate court in Dr Reddy's favour, vacating the preliminary injunction that had prevented Dr Reddy's from bringing this important drug to the public. We are committed to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world and in particular look forward to taking the lead in helping to fight Opioid Use Disorder.'