Dr Reddy's just-approved opioid dependence generic blocked over US patent dispute

Dr Reddy’s Laboratories has taken two steps forward an one step back after its generic version of Suboxone Film (buprenorphine/naloxone) secured FDA approval for the treatment of opioid dependence, only to see the launch of its drug temporarily blocked under a patent protection attempt by the manufacturer of the originator product, Invidior.

Both Dr Reddy’s and Mylan’s generic versions of the dependence therapy were awarded approval from the US regulator at the end of last week, in what was seen as an important step in increasing availability of relevant treatments to tackle the ongoing opioid crisis.

But the US District Court for the District of New Jersey ruled in favour of the original patent owner, ordering Dr Reddy’s to halt any launch activities immediately. Invidior also said that it will be seeking to "extend the cessation of launch activities" from Dr Reddy at a hearing of the preliminary injunction scheduled for 28 June.

Shaun Thaxter, Chief Executive at Indivior, remarked: "This order will stop Dr Reddy's launch activities before the court has had a chance to rule on the preliminary injunction motion," adding, "We will continue to pursue all legal avenues against Dr Reddy's to protect our Suboxone Film patent estate."

Invidior’s successful move to protect the product – which accounts for 80% of its total revenue and generated $1.9 billion through the 12 months ending April 2018 – was met positively, with the company’s shares rising by 6%. In the US, Invidior’s patent protection runs until 2023.

Dr Reddy’s seems unfazed by the legal attacks however, recording in a statement that it "remains confident in its legal positions on this patent and believes it will prevail on the issues raised with respect to the application for injunction", adding that Invidior will be required to supply a bond or other security to the value of $18 million to cover any losses that the Indian firm could suffer during the priod of the temporary restraining order.