Dr Reddy's moves US court

Hyderabad: Dr Reddy's Laboratories has filed a petition in the US Court of Appeals for the Federal Circuit against the preliminary injunction imposed by another US court preventing the Indian drug-maker from selling the generic Suboxone sublingual film in America.

Drug ‘gSuboxone’ which gave a fillip to the net profit of Dr Reddy’s in the first quarter is meant for the treatment of opioid dependence/addiction.
Suboxone recorded sales of around $1.86 billion in the US for the year ending April 2018, according to market reports. 

The US Court of Appeals, which said it may hear the petition in the first week of October, had 'granted-in-part' the motion to expedite the appeal of Dr Reddy's. Based on a petition of Indivior, a specialty pharmaceuticals business listed on the London Stock Exchange.

The US court for the district of New Jersey, had, on July 13, granted the preliminary injunction on the launch of Suboxone by Dr Reddy's which has appealed against the ruling.

Indivior said it would continue to defend its patent rights to the Suboxone film, including opposing Dr Reddy's appeal. On July 26, declaring the Q1 results, Dr Reddy's co-chairman and CEO GV Prasad, admitted that the Suboxone verdict will have negative impact on the ongoing performance of the company at least, for the next 3-4 quarters. “We are cautiously optimistic. While there is pricing pressure in the US market, there is also opportunity elsewhere and US," he added.

For Q1 2018, the company posted 671 per cent year-on-year rise in net profit at Rs 456.10 crore. The pharmaceutical major had posted a net profit of Rs 59.10 crore in the corresponding quarter last year. 

The company’s revenues registered a 12 per cent and 5 per cent jump YoY and QoQ respectively with the gross margins ending up on the higher side with 55.7 per cent jump.

The rise in the net profit was is mainly due to the launch of ‘gSuboxone’ forex gains and operational efficiencies. As of June 30, cumulatively 112 generic filings are pending for approval with the USFDA {including three New Drug Applications (NDA).} Of the109 NDAs pending with the FDA, 61 are Para IVs out of which the company believes 30 have 'First to File status,’ the company officials added.