Indivior: CAFC Vacates Preliminary Injunction Granted Against Dr. Reddy's

(RTTNews) - Indivior PLC (INDV.L) announced that the U.S. Court of Appeals for the Federal Circuit has vacated the preliminary injunction previously granted against Dr. Reddy's Laboratories (RDY) by the U.S. District Court on July 13, 2018.

In the absence of a preliminary injunction, Dr. Reddy's will resume the launch of its generic buprenorphine/naloxone sublingual film product in the U.S. following the issuance of the mandate from the CAFC.

Shaun Thaxter, CEO of Indivior, commented that "We are surprised and disappointed that the court has vacated the preliminary injunction,"

Indivior's FY 2018 guidance for net revenue of $990 million-$1.02 billion and net income of $230 million-$255 million, which was issued on September 26th and confirmed on November 1st, was based on no material changes in current market conditions in the U.S.

However, company's current FY 2018 guidance remains valid unless there is certainty of generic buprenorphine/naloxone sublingual film entry in 2018, in which case there would be risk to FY18 guidance. The magnitude of the risk will depend upon the timing of any generic entry.

Indivior plans to vigorously pursue its infringement cases against Dr. Reddy's to protect SUBOXONE Film patent portfolio.