A US court has approved United Kingdom-based Indivior's preliminary injunction preventing Dr Reddy's Laboratories from marketing of generic opioid addiction treatment, it was reported yesterday.
The US District Court for the District of New Jersey has ruled on a preliminary injunction against Dr Reddy's Laboratories to stop selling or importing its generic buprenorphine/naloxone sublingual film product. Indivior also stated that the court ordered the parties to submit a final proposed injunction order.
According to the company, Dr Reddy's Laboratories marketed a quantity of its generic buprenorphine/naloxone sublingual film into the US market prior to the granting of a temporary restraining order on 15 June. The firm also noted that it does not know the exact quantity of product marketed by Dr Reddy's Laboratories prior to the issuance of the temporary restraining order, but based on the recent abrupt loss of market share for its Suboxon film, the net revenue impact to be around USD25m in the fiscal 2018.
Sublocade (buprenorphine extended-release) injection is Indivior's once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder. The company secured approval from the US Food and Drug Adminsitration (FDA) for Sublocade in November 2017.
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