Dr Reddy's on Thursday said it received an unfavorable ruling in a US court regarding a patent infringement case over its anti-nausea injection Aloxi. It said the US Court for the District of New Jersey had issued its opinion regarding Helsinn Healthcare's patent infringement claims against Dr Reddy's proposed palonosetron product.
Dr Reddy's Laboratories on Thursday said it received an unfavorable ruling in a US court regarding a patent infringement case over its anti-nausea injection Aloxi.
The company said the US Court for the District of New Jersey had issued its opinion regarding Helsinn Healthcare's patent infringement claims against Dr Reddy's proposed palonosetron product.
Dr Reddy's had filed an NDA (new drug application) for Aloxi about three year ago and Helsinn had challenged it.
The court found that Dr Reddy's proposed drug -- palonosetron hydrochloride 0.25 mg/5 ml -- infringes on certain claims of US patents.
The company added it is disappointed at the decision and intends to pursue an appeal in due course.
Aloxi generically called palonosetron HCl injection is a drug to treat chemotherapy-induced nausea and vomiting in patients suffering from cancer.
Analysts say that Aloxi accounts for sales of around USD 600-650 million in the US. It was expected to provide a meaningful opportunity for Dr Reddy's in FY18, somewhere in the range of around USD 40 million in FY18, according to Surajit Pal, Pharma Analyst at Prabhudas Lilladher.
The company was betting on its Aloxi launch to quickly gain market share before it rolled out its generic version of the drug in September 2018 for which it had won an approval.
Dr Reddy's patent claims rested on a minor tweak to the original drug whereby it was hoping to seek approval for the same.
To be sure Dr Reddy's received an approval for generic Aloxi from the US health regulator in March 2016, after it settled patent litigations relating to its anti-nausea injection Aloxi.
The settlement will allow Dr Reddy’s to market the generic version of Aloxi in the US on September 30, 2018 or earlier under certain circumstances.
Helsinn reached a similar settlement over generic Aloxi with Sandoz, the generic pharmaceuticals division of Novartis. Dr Reddy's will have to fight it out with at least two other drug companies for market share of Aloxi.
Shares of Dr Reddy's dropped 1.43 percent and were trading at Rs 2868.30 on BSE at 10.09 am; the benchmark Sensex declined 0.16 percent to 28,201.76 points.