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Last Updated : Feb 20, 2019 09:22 AM IST | Source: Moneycontrol.com

In a major win for Dr Reddy’s, US court allows sale of generic Suboxone film

Rejecting arguments by Indivior, the judge left in force a ruling that allows DRL to put the generic drug on the market as early as February 20

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In a major victory for Dr Reddy’s Laboratories in its legal battle against Indivior in the US, US Chief Justice John Roberts has allowed the former to resume selling the generic version of the latter’s opioid addiction treatment drug Suboxone Film, reports Bloomberg.

Rejecting arguments by Indivior, the judge left in force a ruling that allows DRL to put the generic drug on the market as early as February 20.

Indivior said the Indian drugmaker should wait until the high court considers whether to hear an appeal in the case. The company is also making attempts to overturn a ruling, which states that DRL’s generic doesn’t infringe a related patent on the treatment. The Federal Circuit has agreed to expedite hearing in that case, the report said.

On November 21, 2018, an appeals court had vacated the preliminary injunction order of a federal court that blocked DRL from selling Suboxone. At that time, the US Court of Appeals for the Federal Circuit ruled that the trial judge was wrong to say that Indivior was likely to win its patent-infringement case, before remanding the case to the trial court for further proceedings.

However, investors should keep in mind that should DRL enter the market and then lose the case, it could be ordered to reimburse Indivior as much as three times the amount of profit that it earns from the sale of the generic.

DRL had booked sales of around $10-15 million days after its launch in July before it was stayed by the court. On November 1, 2018, Indivior, the British drugmaker, had claimed it lost between $12 million and $18 million during this brief period, the report stated. On February 14, it announced that it was unable to provide financial guidance for 2019 “given uncertainties surrounding how the US market for both Suboxone Film and generic alternatives will ultimately develop.”

The Suboxone film is absorbed by being placed under the tongue or inside the cheek. It treats addiction to opioids, including heroin and prescription painkillers.

Analysts expect DRL to earn around $50-75 million for the rest of FY19 from this generic. 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.
First Published on Feb 20, 2019 09:22 am
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