The United States District Court of Delaware has ruled in favour of Dr Reddy’s Laboratories against the UK drug firm Indivior’s blockbuster drug Suboxone, (buprenorphine and naloxone) sublingual film. Dr Reddy’s had bought Suboxone Film’s abbreviated new drug application (ANDA) from Teva Pharmaceuticals for $70 million in June 2016 with seven generic filers. The key patent expires in April 2024. However, Indivior said that it would appeal against the US court ruling. “The United States District Court, for the District of Delaware, issued its judgment in favour of Dr Reddy’s Laboratories, ruling that the proposed generic version of Suboxone (buprenorphine and naloxone) sublingual film does not infringe US Patent Nos. 8,017,150; 8,603,514 and 8,900,497 as asserted by Indivior,” Dr Reddy’s said in a statement.
“We are pleased with the verdict passed by the US District Court of Delaware in Dr Reddy’s favour, on the patent litigation of the drug Suboxone. The judgement reiterates our commitment to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world,” Dr Reddy’s spokesperson stated. Suboxone (buprenorphine and naloxone) sublingual film is indicated for the maintenance treatment of opioid dependence. Reckitt Benckiser developed Suboxone sublingual film using MonoSol Rx’s PharmFilm technology. In December 2014, Reckitt Benckiser de-merged its pharmaceuticals business as Indivior. The US Food and Drug Administration (USFDA) has approved Suboxone film in four strengths: 2 mg /0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg (buprenorphine/naloxone). Suboxone Film treats opioid addiction and has a brand size of $1.7 billion in the US, as per IMS Health data.
Meanwhile, Indivior said that it would not be able to rely on patents to prevent Dr Reddy’s from making and marketing a generic alternative to Suboxone Film in the US, unless the court’s ruling was reversed on appeal. The firm said the average market share of Suboxone Film in the US was 61% in 2016 and accounted for 80% of Indivior’s total revenues last year.