In a major relief to a patent litigation, a US court has allowed Dr Reddy’s Laboratories to sell a generic version of the UK-based Indivior opioid treatment Suboxone sublingual film.
In a major relief to a patent litigation, a US court has allowed Dr Reddy’s Laboratories to sell a generic version of the UK-based Indivior opioid treatment Suboxone sublingual film. The United States Court of Appeals for the Federal Circuit has issued a decision in favour of Dr Reddy’s Laboratories, concluding that Indivior had not shown that it is likely to succeed on the merits of its infringement case.
This decision vacates the District Court’s preliminary injunction that had prohibited Dr Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. As a result of this ruling, Dr Reddy’s will resume its launch activities as soon as permitted.
“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,” a company spokesperson said.
In June, the US Food and Drug Administration (USFDA) approved Dr Reddy’s Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the US market. The product was launched immediately after approval, with sales and commercialisation activities halted as a result of a court-imposed temporary restraining order (TRO) against Dr Reddy’s. The TRO did not include a prohibition on commercial manufacturing of the product.
Dr Reddy’s had booked sales of around $10-$15 million days after its launch before it was stayed by the court. Suboxone had sales of around $786 billion in the US for the first nine months of 2018. The drug accounts for about 80% of Indivior’s sales. The company hopes for a quick launch of generic Suboxone sublingual film to improve it sales in the US market.
In a statement, Indivior said that it will continue to vigorously pursue ongoing infringement cases against DRL to protect its Suboxone sublingual film patent portfolio. It is in the process of interpreting the ruling in its entirety and will issue a statement on its implications once this review has been completed.