Indivior's lawyers will be able to begin arguing the drug developer's case against Dr Reddy Laboratories in October, after the US appeals court agreed to speed up the process.
The FTSE 250-listed company also on Monday confirmed that its once-monthly treatment for schizophrenia in adults has been approved by the US drug regulator, but that it would delay the timing of the launch until it knew more about the Dr Reddy's case.
Dr Reddy's launched an appeal after Indivior was granted a preliminary injunction that prevented the generic drugmaker from selling its version of Indivior's Suboxone, a buprenorphine/naloxone sublingual film that is used as a treatment for opioid addiction.
The US Court of Appeals for the Federal Circuit has now granted-in-part a motion to expedite Dr Reddy's appeal of the preliminary injunction that prohibits its from using, importing, selling, or offering to sell its generic sublingual film, meaning oral argument are scheduled to be held during the first week of October.
Dr Reddy's appeal also requested a stay of the injunction but the CAFC has not yet ruled on this.
Although the US Food & Drug Administration over the weekend approved Perseris, a once-monthly injection to treat adult schizophrenia, Indivior said that, as it had indicated in its half-year results last week, it will hold back from launching this new treatment due to the uncertainty over the Dr Reddy's generic.
The company assured that would provide details of the “appropriate launch timing” for Perseris “as soon as reasonably practicable, but no later than its Q3 2018 results currently scheduled for November 1st”.
Perseris contains risperidone, which is a well-established treatment for schizophrenia, but has been formulated by Indivior into an extended-release 'depot' delivery system that is delivered subcutaneously and remains sustained levels over the course of the month.