The product at the centre of the legal wrangle is Suboxone Film (buprenorphine/naloxone sublingual film), used in the treatment of opioid addiction.
Dr. Reddy’s appealed the decision and the US Court of Appeals for the Federal Circuit (CAFC) has approved in-part a motion to expedite this appeal.
This means that the case will now be heard in the first week of October 2018, according to a notice filed to the London Stock Exchange.
Indivior stated in the same notice that it will review the launch timings for its Perseris (risperidone) product, recently approved for the treatment of schizophrenia in adults, after the CAFC’s decision. The company stated that the launch timeline of the product would be announced no later than November 1 of this year.
A weighty decision
Indivior released its results for the first half of the year and the impact that the introduction of Dr. Reddy’s generic onto the market had made on the company was detailed.
It withdrew its full year financial guidance due to the uncertainty regarding the court case with Dr. Reddy’s. It also revealed that the market share for its Suboxone product stood at 49%, down from 54% at the start of the year, “reflecting the market impact of Dr. Reddy’s generic”.
Despite the company’s difficulties with the introduction of Dr. Reddy’s product, CEO, Shaun Thaxter, remains confident that another of its products, Sublocade, an injectable burprenorphine formulation approved in December 2017, would achieve its “1bn+ annual net revenue goal”.
A spokesperson for Indivior stated that no details beyond the company’s announcements could be made.