Moody's has placed the ratings of Indivior PLC's units RBP Global Holdings Ltd. and Indivior Finance Sarl, including the B3 corporate family rating and the Caa1-PD probability of default rating, under review for downgrade.
The ratings action comes after the U.S. Food and Drug Administration's approvals of the first generic versions of Indivior's Suboxone film, which dissolves under the tongue to treat opioid dependency.
The FDA allowed Mylan NV unit Mylan Technologies Inc. and Dr. Reddy's Laboratories Ltd. unit Dr. Reddy's Laboratories SA to market buprenorphine and naloxone sublingual film in multiple strengths.
Canonsburg, Pa.-based Mylan has not confirmed any plans for launching its drug yet, although it settled its patent case with Indivior on Suboxone in 2017.
Meanwhile, Indivior is seeking an immediate court-appointed injunction on a generic launch in order to address its unresolved patent litigation with Dr. Reddy's.
In May, the biopharmaceutical company reached a settlement with Endo International PLC and IntelGenx Technologies Corp., which are looking to market a generic version of Suboxone in the U.S.
U.S. sales of Suboxone film bring in 80% of Indivior's revenue; the launch of a generic version has the potential to rapidly erode its revenues and earnings, according to the rating agency.
The rating agency said that the B3 corporate family rating reflects significant revenue concentration in a key product: Suboxone film. There is also uncertainty involving the time and potential cash outflow relating to legal matters, including an investigation by the Department of Justice.
Indivior said in a statement that it is not possible to precisely quantify the financial impact of generic alternatives on revenues generated from Suboxone film in the U.S. or how fast such an impact would take effect. However, it believes the launch of generics could result in "a rapid and material loss of market share" of the product in the U.S. market within months of a launch.
Indivior also said it has developed detailed contingency plans to be brought into effect in the event of actual market entry by Dr. Reddy's, including the potential launch of an authorized generic as well as defined operational cost savings measures.
The company said the "at-risk" launch by Dr. Reddy's is a result of ongoing patent litigation between the parties and that it will pursue all available legal remedies.