Indivior Plc’s Suboxone Film is the leading opioid addiction treatment in US.
Washington & Mumbai: Dr. Reddy’s Laboratories Ltd. asked a U.S. appeals court to let it immediately begin sales of a generic version of Indivior Plc’s Suboxone Film, the nation’s leading opioid addiction treatment.
The U.S. Court of Appeals for the Federal Circuit had said Tuesday that Dr. Reddy’s could resume sales, but that decision won’t take effect until Indivior gets a chance to ask the panel to reconsider or petition the entire 12-member court to hear the case. Dr. Reddy’s said that could take five weeks or longer.
The lower court order to block the generics, which remains in effect, prevents Dr. Reddy’s “from immediately getting its life-saving FDA-approved generic films to the many thousands of individuals who currently lack access to an affordable, effective treatment for opioid use disorder,” the Indian generic-drug maker said in a request with the court.
Indivior, working with a third party, also could sell its drug without the brand label, as a so-called authorized generic that would undercut Dr. Reddy before it can enter the market, the company said.
Indivior told the court it plans to oppose Dr. Reddy’s request, though hasn’t yet filed its legal arguments. The British drugmaker on Wednesday said its 2018 financial guidance of revenue between $990 million and $1.02 billion remains until there’s more clarity on when the generic version will enter the market. “The magnitude of the risk will depend upon the timing of any generic entry,” it said.
Indivior fell for the second day as analysts downgraded the stock and investors worried it wouldn’t be able to compensate for any loss in Suboxone sales. Shares were down as much as 15 percent in London trading, a day after they plunged 47 percent.
Dr. Reddy’s advanced 6.5 percent to close at 2,601.80 rupees per share in Mumbai, the most since September 2017. The benchmark S&P BSE Sensex closed 0.8 percent lower by comparison.
The latest court ruling will be a shot in the arm for Hyderabad, India-based Dr. Reddy’s. The company has seen declining profits for the past three years and is battling a brutal price war in the U.S. that is squeezing the profits of generic-drug makers.
Almost 875,000 people in the U.S. received Suboxone last year, according to Indivior, which has a 54 percent market share in the drug. The U.K.-based drugmaker reported $768 million in sales during the first nine months of the year, with the bulk coming from Suboxone. It’s working to promote a new opioid addiction treatment called Sublocade.
The Federal Circuit, in a 2-1 ruling, said Tuesday that a trial judge shouldn’t have prevented Dr. Reddy’s from selling generic Suboxone Film while a patent-infringement case is pending. The patent in that case isn’t all that dissimilar from another Indivior patent that a different judge said wasn’t infringed, the majority ruled. Indivior is appealing that non-infringement ruling.
Indivior said it plans to ask the original panel to reconsider the decision, and petition to have it heard before all active judges of the court. Such requests are rarely granted, though the fact it was a 2-1 decision could increase the odds for Indivior.
The case is Indivior Inc. v. Dr. Reddy’s Laboratories S.A., 18-2167, U.S. Court of Appeals for the Federal Circuit (Washington). – Bloomberg