Pharma major Dr Reddy's Laboratories will continue to aggressively challenge patents on drugs in the US despite the recent denial of a 180-day marketing exclusivity to its generic Omeprazole 40 mg capsules by the US Food and Drug Administration. Omeprazole is indicated for the treatment of duodenal and gastric ulcers.
The FDA granted the marketing exclusivity to Andrx group of the US. The loss of marketing exclusivity is a setback for Dr Reddy's, but this will be temporary. This is to be expected in the game of patent challenges but since generic drugs provide an enormous opportunity, Dr Reddy's Laboratories will continue to aggressively challenge the patents on other drugs.
Apart from generic drug challenges, Dr Reddy's Laboratories is also focusing on patent generic drugs, innovative drug deliveries and drugs which are difficult to formulate. Nothing can be as profitable as a generic drug, because of the manufacturing cost advantage. In fact, the marketing exclusivity on fluoxetine is the best thing to have happened to Dr Reddy's in a very long time.
The next generic drug which Dr Reddy's hopes to launch in the US is Ciprofloxacin, on which Bayer AG has a patent till December 2003. Other generic drugs in Dr Reddy's pipeline are Olanzapine, on which Eli Lilly has a patent, and Ondansetron, on which Glaxo SmithKline Beecham has the patent, but these will be in 2004.