U.S. top court rejects bid to block Indivior opioid drug copycat

[February 20, 2019]  By Andrew Chung

WASHINGTON (Reuters) - The U.S. Supreme Court dealt a blow to Indivior Plc on Tuesday, clearing the way for a copycat version of the British pharmaceutical firm's lucrative opioid addiction treatment Suboxone Film in a victory for India-based generic drug maker Dr. Reddy's Laboratories.

Chief Justice John Roberts, in a brief order, denied Indivior's request to put on hold a lower court's ruling that had opened the door to cheaper generic versions of Suboxone while the company prepares an appeal to the high court.

The United States faces an opioid abuse epidemic that President Donald Trump has declared a public health emergency. Suboxone Film, which absorbs into the body by dissolving under a patient's tongue or along the cheek, can be used to treat addiction to heroin and prescription painkillers.

In November, the Washington-based U.S. Court of Appeals for the Federal Circuit, which specializes in patents, lifted a preliminary injunction that had blocked Dr. Reddy's from selling its generic version, saying a federal judge had erred in granting the request. That ruling sent Indivior's stock price tumbling.

Indivior, based in Slough, England, has been battling in court to protect Suboxone from generics for several years, with the suit claiming Dr. Reddy's copycat would violate a patent on the treatment filed in New Jersey federal court in 2017.

Indivior told the justices in court papers that an unfavorable ruling would have grave consequences for the company going far beyond lost sales. Suboxone Film accounts for 98 percent of Indivior's U.S. revenue.

"An entire business, and the jobs and livelihoods that depend on it, will be in peril," Indivior said.

Indivior earlier in February reported $1.01 billion in sales for 2018. Once generic versions are available, it said, Suboxone Film could lose up to 80 percent of its market share within months.

Indivior, which was spun off from consumer products group Reckitt Benckiser in 2014, said it expects to launch an authorized generic of Suboxone Film if competitors are allowed to launch their products to capture some of the generic market.

(Reporting by Andrew Chung; Editing by Will Dunham)

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