The AGs had claimed that Invidior used 'product hopping' to block competition from generics for its opioid treatment drug.
Drugmaker Invidior PLC says it will pay $102.5 million to 41 states and the District of Columbia to settle antitrust allegations related to the marketing of its opioid recovery drug Suboxone.
Invidior CEO Mark Crossley says the settlement amount is in line with the original provision of $290 million for the multi-district litigation. Payment is expected to be made this month, with funds coming from the Invidior's existing cash.
"Indivior is focused on helping those who suffer from substance use disorders," Crossley says in a media release. "We take our role as a responsible steward of medications for addiction and rescue extremely seriously. Resolving these legacy matters at the right value allows us to further this mission for patients.”
Indivior got Food and Drug Administration approval for Suboxone in 2002. The prescription drug is used by recovering opioid addicts to reduce or avoid withdrawal symptoms. Along with the FDA approval, Indivior was granted an exclusive seven-years window to sell the drug. In 2010 — a year after Indivior's exclusive right to the Suboxone tablet expired and generics were set to compete — the company switched from tablet to sublingual film, alleging safety concerns.
In response, the AGs sued Indivior in 2016, claiming the company blocked competition by with a scheme known as “product-hopping”, where drugmakers retain a monopoly on profitable drugs by slightly reformulating them to block generics without delivering new therapeutic benefits for patients.
California Attorney General Rob Bonta, whose state will get $7.1 million from the settlement, says high drug costs are a big problem for Californians, “and Indivior contributed to that problem by preventing lower cost generics from competing with Suboxone.
"Opioid addiction treatments should be accessible to everyone — especially our most vulnerable populations that need them for their recovery,” Bonta says. “With today's settlement, we're holding Indivior accountable and ensuring it doesn't engage in similar anticompetitive conduct in the future."
In addition to requiring Indivior to pay $102.5 million:
- Indivior must provide the states with information and reasons for any reformulated versions of Suboxone;
- Indivior must leave the Suboxone on the market for a limited period if generic alternatives are brought out, thus allowing doctors and patients to choose which formulation they like better;
- If Indivior files an FDA Citizen Petition to delay generic competition, it must also submit any data or information underlying that petition to the FDA and the states.
“With today's settlement, we're holding Indivior accountable and ensuring it doesn't engage in similar anticompetitive conduct in the future.”
California Attorney General Rob Bonta
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.
Indivior got FDA approval for Suboxone in 2002, along with an exclusive seven-years window to sell it.
In 2010 — a year after Indivior's exclusive right to the Suboxone tablet expired — the company switched from tablet to sublingual film.
The AGs claim Invidior retained a monopoly on the profitable drug by slightly reformulating it to block generics without delivering new therapeutic benefits.