Ranbaxy’s right to sell a generic version of Pfizer’s cholesterol-lowering drug, Lipitor, in the United States for six months has been challenged in a court. This is considered a $600-million (Rs 2,700 crore) opportunity for the company. US-based Mylan Laboratories has sued the US Food and Drug Administration (FDA) for giving this opportunity to Ranbaxy. The company wants that all generic players including Mylan be allowed to enter the market as soon as the patent protection on Lipitor ends in November.
Ranbaxy holds the right as it was the first to challenge a later date patent on the drug and apply for supply of a generic, low-cost version as soon as the basic patent expires. According to Mylan, Ranbaxy was not eligible for marketing exclusivity because of “false and unreliable data” from its manufacturing site in Paonta Sahib, India, where Lipitor’s copies would be produced. The facility was earlier under the FDA scanner for falsifying data.
