A box of Indivior’s Suboxone medication on a pharmacy shelf. (Photographer: George Frey/Bloomberg)

Supreme Court Justice Refuses to Block Generic Suboxone Film

(Bloomberg) -- U.S. Chief Justice John Roberts cleared the way for Dr. Reddy’s Laboratories Ltd. to resume selling a generic version of Indivior Plc’s opioid addiction treatment Suboxone Film.

Rejecting arguments from Indivior, Roberts left in force a ruling, set to take effect Tuesday, that lets Dr. Reddy’s put the generic drug on market. Indivior said Dr. Reddy’s should wait until the high court considers whether to hear an appeal in the case.

Dr. Reddy’s had received regulatory approval to sell a generic version of the drug in July before it was shut down by a federal judge who said it had to wait for a final decision in the patent case. The U.S. Court of Appeals for the Federal Circuit, in a 2-1 ruling in November, ruled that Dr. Reddy’s was likely to win the case so sales should be allowed to proceed.

Indivior has fought to prevent that appeals court decision from taking effect, saying it would cause “immediate, severe and irreversible” harm. Separately, it’s trying to get overturned a ruling that Dr. Reddy’s doesn’t infringe a related patent on the treatment. The Federal Circuit has agreed to expedite a hearing in that case.

Suboxone accounted for almost all of the company’s $1 billion in sales last year, and the company said on Feb. 14 that it’s unable to provide financial guidance for 2019 “given uncertainties surrounding how the U.S. market for both Suboxone Film and generic alternatives will ultimately develop.”

The company also is working to promote a new opioid addiction treatment called Sublocade. That generated just $12 million in sales last year, but the company is expecting it to grow to blockbuster status.

Officials with Indivior and Dr. Reddy’s didn’t immediately respond to queries seeking comment.

Suboxone Film, absorbed by being placed under the tongue or inside the cheek, treats addiction to opioids including heroin and prescription painkillers. The drug combines buprenorphine, which tricks the brain into thinking it’s still getting the drug, with naloxone, a medicine used to reverse the effects of an overdose.

Should Dr. Reddy’s enter the market and then later lose the case, it could be ordered to reimburse Indivior for as much as three times the amount of profits the British drugmaker loses. Indivior said Nov. 1 that it lost between $12 million and $18 million for the brief period Dr. Reddy’s was on the market in July.

Indivior’s request went to Roberts because he is the justice assigned to handle emergency matters from the Federal Circuit.

The appeals court case is Indivior Inc. v. Dr. Reddy’s Laboratories SA 18-2167, U.S. Court of Appeals for the Federal Circuit (Washington).

©2019 Bloomberg L.P.