SAN FRANCISCO (KRON) — As California struggles to stem a tragic tide of fatal fentanyl overdoses, a global pharmaceutical company will pay more than $100 million for allegedly stifling access to opioid addiction treatment drugs, the Attorney General announced Friday.
California Attorney General Rob Bonta joined a coalition of 42 attorneys general in announcing a settlement against Invidior Inc. to resolve allegations that the global pharmaceutical company violated antitrust laws by attempting to maintain market exclusivity over Suboxone.
Fentanyl is a highly addictive and powerful opioid. Manufactured and marketed by Invidior, Suboxone is a prescription drug approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment.
As part of the settlement, Indivior will pay $102.5 million to the states and be prohibited from engaging in future anticompetitive conduct. California will receive over $7.1 million of the multistate settlement funds.
“The cost of prescription drugs is a tremendous problem for many Californians, and Indivior contributed to that problem by preventing lower cost generics from competing with Suboxone, their branded opioid addiction treatment drug,” said Attorney General Bonta.
In 2021, more than 7,000 Californians died from opioid-related overdoses, according to the California Department of Public Health’s surveillance dashboard. Fentanyl caused nearly 6,000 of those deaths.
“Opioid addiction treatments should be accessible to everyone — especially our most vulnerable populations that need them for their recovery. With today’s settlement, we’re holding Indivior accountable and ensuring it doesn’t engage in similar anticompetitive conduct in the future,” Bonta said.
Also under the settlement:
- Indivior must provide the states with information and reasons for any reformulated versions of Suboxone.
- If pharmaceutical companies file for Food and Drug Administration approval of generic versions of Suboxone, Indivior must leave the original product on the market for a limited period to allow doctors and patients to choose which formulation they like better.
- If Indivior files an FDA Citizen Petition in an attempt to delay generic competition in the future, it must also submit any data or information underlying that petition to the FDA and the states.
Indivior received FDA approval for Suboxone in 2002, along with exclusive rights to sell the drug for seven years based on representations that it was otherwise unlikely to recover its investment in the drug, according to the Attorney General’s Office. “Suboxone originally came in tablet form. However, in 2010 — a year after Indivior’s exclusive right to the Suboxone tablet had expired and generic manufacturers were set to enter the market — the company switched from tablet to sublingual film, falsely citing safety concerns. Sublingual film is a dissolving film,” the AG’s Office wrote.
In response, the California Attorney General and fellow attorneys general sued Indivior in 2016, alleging that Indivior engaged in a “product-hopping” scheme to block competition to Suboxone. In such a scheme, pharmaceutical companies try to maintain profits generated via a monopoly by slightly reformulating their product in a way that blocks generic competitors without offering any significant medical or therapeutic advantages to patients.
In April 2021, Attorney General Bonta announced a separate $300 million settlement against Indivior resolving claims that Indivior falsely and aggressively marketed Suboxone, resulting in improper use of state Medicaid funds. California was a part of the team of states that negotiated the settlement.