Dr Reddy's Laboratories receives US court approval to launch generic version of Indivior's Suboxone
14 February 2019 -

India-based Dr Reddy's Laboratories has received approval from the United States court to introduce a generic version of Indivior's Suboxone (buprenorphine and naloxone) sublingual film, which is an opioid addiction treatment, it was reported yesterday.

The US Court of Appeals for the Federal Circuit (CAFC) has rejected Indivior's motion to stay issuance of the mandate following its ruling vacating the preliminary injunction granted against the Indian company. Based on the decision, Indivior has filed an emergency motion to stay the mandate pending resolution of its forthcoming application for an administrative stay to the US Supreme Court.

If granted, the stay is likely to have permitted the Supreme Court time to resolve whether to administratively stay the CAFC mandate while it considered Indivior's application to stay the mandate pending disposition of a petition. The CAFC has rejected the motion on 11 February and ordered that the mandate issue on 19 February. Indivior is also planning to lodge a petition to stay the mandate with the US Supreme Court.

Once the mandate is issued, Dr Reddy's and Alvogen Pine Brook cannot sell or import their generic buprenorphine/naloxone sublingual film product.