Transatlantic drugmaker Indivior has been granted a temporary restraining order by a court in New Jersey, preventing Indian manufacturer Dr Reddy’s from pursuing an “at-risk” launch of a generic version of opioid addiction treatment Suboxone.

The New Jersey District Court granted Indivior’s request on 15 June, the company said, a day after the US Food and Drug Administration approved the launch of the first generic versions of Suboxone – a drug used in addiction treatment to reduce the effects of opium withdrawal, which is administered as an under-the-tongue (sublingual) dissolvable film.

London-listed Indivior has filed a series of lawsuits in New Jersey and Delaware seeking to block various companies’ generic versions of the drug coming to market, claiming it was still protected by patents owned by Indivior’s UK arm. In March, the company vowed to appeal against a judgment in a related suit, which dismissed its claims that rival pharma company Alvogen’s methods of producing sublingual films also violated patents in force.

In its 14 June announcement, the FDA said it was committed to improving access to medicine-assisted opioid addiction treatments, in part through increasing generic market entry. “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them,” FDA Commissioner Scott Gottlieb said. “That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access”.

Indian multinational pharma company Dr Reddy’s, which is so far the first manufacturer to launch a generic version of Suboxone following the FDA’s announcement, said on 15 June that it was not barred from continuing to make its films while the New Jersey court’s temporary order was in place and that it was “confident in its legal positions” vis-a-vis its right to launch its product in the US. The generic film was launched “at-risk”, meaning the associated patent litigation was yet to be resolved in Dr Reddy’s’ favour, and could result in a permanent injunction and damages being awarded against the company. 

The court has scheduled an expedited hearing on the preliminary injunction for 28 June, Dr Reddy’s said, noting that Indivior would be required to post a US$18 million bond to cover any losses incurred by the generic manufacturer while the restraining order is in place.

“We are surprised by Dr Reddy’s decision to launch ‘at risk’ given the ongoing litigation and associated significant risk to them of substantial economic damages if, as we believe, we eventually prevail in protecting the SUBOXONE® Film patent estate,” Indivior CEO Shaun Thaxter said in a statement following the launch.

Indivior said it had “detailed contingency plans” in place should Dr Reddy’s be allowed to continue selling its films in the US, including the possible launch of its own generic version of Suboxone alongside targeted reductions to its operating costs.

The FDA said increasing access to addiction treatment and recovery services was part of its wide-reaching plan to tackle the opioid crisis in the US that has seen sharp increases in associated overdose deaths since the turn of the century. Opioid manufacturers meanwhile have been hit with an avalanche of lawsuits in recent years as states, counties and tribes attempt to assign them liability for the epidemic.

In a lengthy complaint against opioid-maker Purdue Pharma from August 2017, New Hampshire – labelled by Drug Enforcement Agency officials as “ground zero” for the opioid crisis – said that between 1999 and 2015 “more than 194,000 people died in the US from overdoses related to prescription opioids – more than the number of Americans who died in the Vietnam War.”

In the United States District Court for the District of New Jersey

Indivior Inc v Dr Reddy’s Laboratories et al

  • Judge Kevin McNulty

Counsel to Indivior and Aquestive Therapeutics

  • Covington & Burling

Jeffrey Elikan, Jeffrey Lerner, Erica Andersen, Jason Fowler and Philip May in Washington, DC

  • Steptoe & Johnson

James Hibey in Washington, DC and Jamie Lucia in San Francisco

  • Troutman Sanders

Daniel Ladow, James Bollinger, Timothy Heaton, Magnus Essunger, Katherine Harihar and Gerald Porter in New York. Charanjit Brahma in San Francisco. Daniel Sharpe in Washington, DC.

  • Saul Ewing Arnstein & Lehr

Charles Lizza, William Baton and David Moses in New Jersey

Counsel to Dr Reddy’s

  • Lerner David Littenberg Krumholz & Mentlik

William Mentlik and Aaron Eckenthal in New Jersey