Indivior To Pursue All Legal Remedies To Protect Its SUBOXONE Film In U.S.

(RTTNews) - Indivior PLC (INDV.L) announced that it is aware that Dr. Reddy's has launched its generic buprenorphine/naloxone sublingual film product "at-risk" in the US. On 14 June 2018, the US FDA approved generic versions of SUBOXONE Film from both Dr. Reddy's and Mylan.

Indivior noted that such an "at-risk" launch by Dr. Reddy's is a result of ongoing patent litigation between the parties. Indivior said it will pursue all legal remedies available to it, including seeking an immediate injunction.

Indivior believes the launch of generic alternatives to SUBOXONE Film could potentially result in a rapid and material loss of market share for SUBOXONE Film in the US. Until the details of Dr. Reddy's market entry are confirmed, Indivior's guidance for 2018 remains unchanged.