Indivior has been fighting off generics to its top-selling Suboxone film, but a federal appeals court has unleashed copycats now charging toward launches next week. And that means hundreds of millions in lost sales for a company that's been hurting for sales from follow-up drugs.
The U.S. Court of Appeals for the Federal Circuit on Monday denied U.K.-based Indivior’s request to reconsider its decision to toss an injunction that would have barred generic sales by Dr. Reddy’s Laboratories. The Indian drugmaker had launched its copies at risk and Indivior won the now-nixed injunction.
With the court's decision to lift that ban and reject another hearing, Jefferies analyst James Vane-Tempest expects Dr. Reddy’s to launch its generic next week. The analyst expects Alvogen and Mylan to launch generics as well, he wrote in a Tuesday note to investors.
Suboxone could lose 80% of its market share “within a matter of months” after a generic rollout, the company said. The opioid addiction-fighting film makes up the majority of Indivior's sales, expected to come in at about $1 billion for 2018. Indivior shares were down about 11% Tuesday morning and have dropped 70% over the past year.
No wonder Indivior still isn't giving up. The company says it's planning an emergency motion to stay the generic launch pending a petition at the Supreme Court. That's a bid not likely to bear fruit, though, Vane-Tempest figures. Indivior’s move to seek a further delay and take the issue to the Supreme Court “is unlikely to be successful in our view,” the analyst wrote.
Suboxone film, containing buprenorphine and naloxone, is placed under the tongue and is used to treat patients with opioid addiction. It's a follow-up to a tablet version that's already facing generic competition.
“While we ultimately believe in the strength of our patent portfolio, we acknowledge that the company faces major disruption in the immediate future from a potential material and rapid loss of market share by our Suboxone film product to generic buprenorphine/naloxone sublingual film competition,” Indivior CEO Shaun Thaxter said in a statement.
Indivior expects $990 million to $1.02 billion in sales for the year, with Suboxone film generating most of the haul. Its new buprenorphine injection, Sublocade, is only expected to bring in $8 million to $10 million, while Perseris to treat schizophrenia isn’t expected to generate material sales, the company said after its third quarter results.
While generics would represent a major threat to Indivior’s top drug, the company has “contingency plans,” Vane-Tempest wrote. Indivior plans to bolster launches for Sublocade—which it insists can grow to blockbuster status—and Perseris, while keeping a cash balance of at least $250 million to stay complaint with its debt agreements. The company aims to have about $920 million in cash at the end of its fiscal year 2018. Indivior reports full-year 2018 sales next week.