Dive Brief:
- A group of 35 U.S. states and the District of Columbia on Thursday sued British drugmaker Indivior over alleged antitrust violations, sending the company's shares down sharply in Friday trading on the London stock exchange.
- Indivior, which makes several buprenorphine-based treatments for opioid dependence, said in a statement it would "vigorously defend its position."
- The civil complaint filed by the states is related to antitrust investigations launched by the U.S.Federal Trade Commission and the New York State Attorney General, both of which allege Indivior attempted to delay U.S. approval of generic copies of its drugs.
Dive Insight:
The civil compliant filed by the 35 states and D.C. had been expected for some time, although Indivior had initially anticipated fewer states would join the lawsuit. The New York state investigation has now been incorporated within the broader multi-state investigation.
Shares in Indivior fell sharply by as much as 17.5% in Friday trading on the London stock exchange before reversing some of those losses.
Indivior, which split off from Reckitt Benckiser to become a standalone company in 2014, markets several products to treat opioid-dependence. Generic competition has hurt sales in the U.S., stealing market share away from Indivior's Subutex (buprenophine) tablet and Suboxone (buprenorphine/naloxone) tablet.
Almost 80% of Indivior's net revenues last year came from sales of film version of Suboxone, which has a nearly 60% share of the market for buprenophine-based opioid dependence treatments, according to a recent regulatory filing.
Six generic drugmakers are attempting to bring in generic copies of Suboxone film. Indivior has challenged all six applicants with patent infringement lawsuits, staving off competition for now.
The FTC investigation and lawsuit by the states relate to Indivior marketing practices for Suboxone tablets and Suboxone film.
According to a statement from the New York Attorney General, Indivior allegedly attempted to "coerce" patients to switch from the tablet form of Suboxone to the dissolvable film form in an attempt to preserve its market share. In order to encourage this switch, Indivior purportedly claimed the tablet version was unsafe due to its potential risk for accidental exposure to children.
"My office will not permit drug companies to engage in anti-competitive conduct that unlawfully extends their monopolies – and their monopoly profits – on drugs," said Attorney General Eric Schneiderman in the statement.
Jefferies equity analysts James Vane-Tempest, writing in a note to investors, believes Friday's market reaction to the lawsuit to be "overdone," given the legal proceedings were previously communicated and expected.
As the opioid crisis in the U.S. has grown, treatments for opioid dependence have received more attention. Regulators and the federal government have taken steps to make such treatments, including naloxone and buprenophrine-containing products, more available to patients.