US court prevents Dr Reddy's from launching opioid treatment drug Suboxone

The preliminary injunction orders issued on Friday by a US court against Dr Reddy's Laboratories Limited on the launch of generic Suboxone, a sublingual film product indicated for treatment of opioid dependence, comes as a set back for the company.

This preliminary injunction was followed after the District Court of the District of New Jersey issued a temporary restraining order on June 16 against further sale and commercialisation of generic Suboxone by Dr Reddy's in the US.

With sales of around $1.86 billion annually, Suboxone was one of the key near-term launches lined up by Dr Reddy's this year with other products being generic NuvaRing and generic Copaxone among others. 

Hit by fewer US launches and consequent fall in US revenues in the past two years, Dr Reddy's was betting big on Suboxone and the other key products to open the current year with a revenue upside from its largest overseas market.

In a statement issued on Saturday, Dr Reddy's said it disagrees with the court's decision, and vigorously appeal against it. The UK based pharma company Indivior PLC had got the restraining orders against Dr Reddy's just a day after the US FDA granted the final approval last month.

Delay in the launch of copies of blockbuster drugs has become a double whammy for Indian generic players like Dr Reddy's on account of steep fall in prices of these drugs due to increased competition in the US. The delay in approval for Dr Reddy's generic multiple sclerosis drug Copaxone was already a case in point where US generics player Mylan, which had got the first approval, recently cut the price of its product to $ 190 per month's treatment from $ 500 in a bid to counter Teva's strategy.

In the present case the Indian pharma major took comfort from the fact that the court has also ordered Indivior to post a bond to provide security to Dr Reddy's in case the court concludes at the end of the patent litigation that the patent was invalid or not infringed. Last month Dr Reddy's had also expressed confidence of winning the ongoing court battle since the proceedings only involved one patent, US Patent no, 9,931,305.

Indivior recently said that Dr Reddy's had sold a quantity of its generic Suboxone into the US market before it was issued a temporary restraining order on June 15. Based on the recent abrupt loss of market share for its Suboxone product, Indivior anticipates a net revenue impact of at least $ 25 million, according to reports. If there was no restraining of Suboxne sales by the court, Dr Reddy's would have made a good beginning in the first quarter itself.

Indivior CEO Shaun Thaxter said that the latest court ruling has prevented Dr Reddy's from re-launching its generic product until the patent litigation related to the '305 patent is concluded or until Dr Reddy's prevails on an appeal of this injunction.

Firm to contest order
  • UK-based Indivior had got the restraining orders against Dr Reddy’s a day after the US FDA granted the final approval last month
  • With annual sales of around $1.86 billion, Suboxone was one of the key near-term launches lined up by 
  • Dr Reddy’s this year, besides generic NuvaRing and the generic Copaxone
  • In a statement on Saturday, Dr Reddy’s said it disagrees with the court’s decision and will vigorously appeal against it

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