Mumbai, Dec. 12: The US District Court is expected to give its opinion in a vital case concerning a blockbuster new drug application (NDA) from Dr Reddy’s Laboratories Ltd (DRL) on December 17.
DRL today informed the stock exchanges that an oral argument of its motion to dismiss a complaint in the Amlodipine Maleate case was heard on December 11 in the US District Court for the district of New Jersey.
While the court did not arrive at a decision at the time, it indicated that it intended to give its opinion on December 17. This follows a suit filed by Pfizer Inc, the original patent holder of the drug Norvasc (of which Amlodipine Maleate is a main ingredient) alleging infringement of one of its patents. Subsequently, Dr Reddy’s filed a motion to dismiss the complaint.
Analysts aver that the opinion will be crucial for DRL, which recently witnessed a string of setbacks in its generic initiatives. A US court ruled in October that the company, along with two other generic drug makers, had infringed two key patents of AstraZeneca Plc’s heartburn drug, Prilosec.
Another ruling against it and other generic drug manufacturers in a patent infringement case over Bayer AG’s Cipro preceded the AstraZeneca blow. All these developments adversely affected the company’s stock price.
Industry observers attach importance to this NDA filing which is an “innovation” over the existing product. While DRL would get the opportunity to brand it and market it by itself, it could also obtain product exclusivity till three years for a product that has clocked sales of around $ 1 billion.