US court extends restraining order against Dr Reddy's generic drug

The restraining order was extended for another 14 days on June 15 during which time the US court will consider the application and issue a ruling on the injunction

Indivior Plc said on Friday a US court extended the restraining order blocking Indian pharmaceutical firm Dr Reddy's Laboratories from launching a generic version of the British drugmaker's bestselling opioid addiction treatment in the United States.

Dr Reddy's and US-based Mylan NV received approval from the Food and Drug Administration (FDA) earlier this month to launch a generic version of Suboxone Film, which generates 80 per cent of Indivior's revenue, forcing the UK company to file an injunction against the decision.

Indivior said its restraining order, issued on June 15, was extended for another 14 days, during which time the US court for the District of New Jersey will consider the application and issue a ruling on the injunction.

The company warned earlier that Dr Reddy's launch could result in a rapid and material loss of US market share for Suboxone Film, which is placed under the tongue to suppress cravings.

Generic rivals in tablet form are already on the US market, which is grappling with an opioid addiction epidemic that killed 33,000 people in 2015.

Dr Reddy's said earlier this month it would launch its new drug regardless of the legal squabble. Indivior said then that it was considering a potential launch of its own generic version in response.

Indivior's contingency plans would also focus on supporting and optimising the launch of Sublocade, a once-a-month injectable drug to suppress opioid craving, launched in the United States in February.