RESTRAINT ORDER AGAINST DR REDDY’S GENERIC DRUG IN US

Order follows launch of generic variant of Suboxone in US

Dr Reddy’s Laboratories revealed on Saturday that after the launch of its generic Buprenophine and Naloxone Sublingual film in the US market, the US district court of New Jersey issued a temporary restraint order and preliminary injunction against the company with regard to a patent litigation. Pending a hearing and decision on the injunction, the court issued a temporary restraint order against Dr Reddy’s with regard to further sales and commercialisation of the drug.

Pharma major Dr Reddy’s Laboratories said on Saturday that after the launch of its generic Buprenophine and Naloxone Sublingual Film in the US market, the US district court of New Jersey issued a temporary restraint order and preliminary injunction against the company with regard to patent litigation.

Pending a hearing and decision on the injunction application filed by Indivior Plc, the court issued a temporary restraint order against Dr Reddy’s with regard to further sales and commercialisation of the drug, which is used to treat adults with opioid dependence addition.

“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 restraint order,” Dr Reddy’s said in a statement on Saturday.

The court has scheduled an expedited hearing of the preliminary injection for Thursday (June 28) and a ruling is expected soon after, the company said.

The proceedings only involves one patent (US patent no. 9,931,35), it said.

On Friday, Dr Reddy’s announced the launch of Buprenophine and Naloxone Sublingual Film, a generic equivalent of Suboxone that registered sales of approximately $1.8 billion for the 12 months ending April 2018, in the US.