Last month’s news that a Delaware court is allowing Dr. Reddy’s, a huge supplier of generic drugs based in India, to produce a generic version of buprenorphine-naloxone film resulted in an immediate response from Indivior, which makes Suboxone (buprenorphine-naloxone film) and has enjoyed a monopoly on it. Reckitt Benckiser (which Indivior spun off from in 2014) aroused outrage in the treatment field when generic versions of its Suboxone tablet came on the market and it responded by pulling the tablets, making only its patented film available. Now, Indivior will appeal the court ruling.
We asked Ed Silverman, senior writer and Pharmalot columnist at The Boston Globe’s STAT health and medicine site, what the next steps are for Dr. Reddy’s and any other company that wants to make generic buprenorphine-naloxone film. First, the generics have to be approved by the Food and Drug Administration (FDA). “If you’re the brand-name company and a generic company seeks FDA permission and files an application to market a generic version, the brand-name company goes to court to file a patent infringement lawsuit,” said Silverman. Recently, Scott Gottlieb, M.D., the new FDA commissioner, said the agency "would seek to accelerate reviews of generic applications so that more are approved,” he added. “That is definitely part of the equation.”
One question is how much less expensive the generic versions will be than Suboxone. Even if people still want to stay on Suboxone, or start on it, the price of a brand “typically comes down 70 to 80 percent within a few weeks or a few months” of introduction of a generic, said Silverman. “But it doesn’t always happen that way,” he said. Product choices could also depend on insurance coverage. And some plans get rebates for branded drugs that lower the costs, he noted.
Would the generic work as well as the brand? “Traditionally, a generic has to be proven bio-equivalent,” said Silverman. “That means it has to have a proximate effect on the patient. But the generic company doesn’t have to do lots of independent trials."
In the case of Suboxone, the costs of development were paid by the taxpayer, under the stewardship of the National Institute on Drug Abuse, with the pharmaceutical company sponsor pocketing the profits after marketing was approved.
“Although it is not possible to quantify precisely the financial impact that the launch of generic alternatives to Suboxone Film would have on the Company’s revenues generated from Suboxone Film in the US, or how quickly such an impact would take effect, the Company believes that it could potentially result in a rapid and material loss of market share for Suboxone Film in the US, an effect that could occur within months of a successful launch of a generic film alternative into the US market,” according to a statement from Indivior released Sept. 1. “Today’s news is disappointing to Indivior, given the belief that the Company has in its intellectual property for Suboxone Film,” said Indivior CEO Shaun Thaxter. “We will appeal the ruling and defend our intellectual property.… As always, our unwavering focus is on addressing the unmet needs of opioid dependent patients. On behalf of the millions of patients who struggle to overcome opioid addiction, the majority of whom need help but go untreated, we remain relentless in our pursuit to transform addiction from a global human crisis to a recognized and treated disease.”