Dr Reddy's generic opioid addiction drug launch faces court hurdle in US

Dr Reddy's recently announced the launch of Buprenophine and Naloxone Sublingual Film, a generic equivalent of Suboxone

Dr Reddy's Laboratories Limited on Saturday announced that following the launch of its generic Buprenophine and Naloxone Sublingual Film in the US market, the US District Court for the District of New Jersey has issued a temporary restraining order and preliminary injunction against the company in a current patent litigation. 

Pending a hearing and decision on the injunction application filed by Indivior PLC, the court has issued a temporary restraining order against Dr Reddy's with respect to further sales and commercialisation of the drug, which is used to treat adults with opioid dependence/addiction.

"The court order does not include prohibition on commercial manufacturing of the product. The plaintiffs will be required to post a bond or other security totalling $18 million to satisfy any losses or damages incurred by Dr Reddy's during the period of the temporary restraining order," Dr Reddy's said in a statement on Saturday.

The court has scheduled an expedited hearing of the preliminary injunction for June 28 and a ruling is expected soon thereafter, according to the company. The proceedings only involve one patent (US Patent no 9,931,35) and the company is confident in its legal positions on this patent, it said.

On Friday, Dr Reddy's announced the launch of Buprenophine and Naloxone Sublingual Film, a generic equivalent of Suboxone that had US sales of approximately $1.8 billion for the most recent twelve months ending in April 2018.