US appeals court allows Dr Reddy's Labs to sell generic Suboxone

Dr Reddy's won a major legal battle against Indivior in US, with an appeals court vacating preliminary injunction order of a federal court that blocked the former from selling the generic version of the opioid treatment drug Suboxone.

A trial judge was wrong to say that Indivior was likely to win its patent-infringement case, said the US Court of Appeals for the Federal Circuit in a 2-1 ruling, before remanding the case to the trial court for further proceedings.

Analysts expect Dr Reddy's to make around $50-75 million in rest of FY19. 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 percent of Indivior's sales.

On July 13, Dr Reddy's  received a setback when the District Court of New Jersey converted a temporary injunction against it into a preliminary injunction that prevents it from launching the drug in the US until the patent litigation pertaining to US Patent No. 9,931,305 is concluded.

Dr Reddy's launched its generic buprenorphine/naloxone sublingual film or Suboxone, which is used in the treatment of opioid dependence, "at-risk" in the US after it got a final approval from the US FDA on June 15.

An "at-risk" launch of a generic drug is when a company launches the drug for sale while the patent litigation is still ongoing.

Specialty drug maker Indivior, which British drug maker Reckitt Benckiser spun off as a separate company four years ago, approached the court and secured an immediate injunction against Dr Reddy's from on the grounds of pending patent litigation.

​The Hyderabad-based drug maker is pinning hopes on the quick launch of generic Suboxone sublingual film to revive its sagging fortunes in US market, where it was bogged down by lack of significant approvals and regulatory compliance issues for last three years.

“Indivior is disappointed that the US Court of Appeals for the Federal Circuit has vacated the preliminary injunction against Dr. Reddy’s," Indivior said in a press statement.

"Indivior will continue to vigorously pursue ongoing infringement cases against DRL to protect its Suboxone sublingual film patent portfolio," the company said.

Indivior added that 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.

Indivior is working to promote a new opioid addiction treatment called Sublocade to compensate for loss of Suboxone.