DRUGMAKER Mylan Pharma’s lawsuit to strip Ranbaxy of its ?statutory hard-earned? 180 days of marketing exclusivity in case of the generic version of Lipitor (atorvastatin calcium) is a strong attack on the critical six months marketing exclusivity incentive granted to generic players under the Hatch Waxman law. Ranbaxy Labs Ltd has said this in its reply memorandum urging the US district court to dismiss the complaint.
Lipitor is Pfizer?s blockbuster cholesterol lowering drug that clocks annual sales of around $7.2 billion in the US market (according to IMS Health data) and is the most prescribed drug in the US and worldwide.
Last month, Mylan sued the US Food and Drug Administration, seeking to block Ranbaxy’s exclusive rights to sell a generic version of Lipitor, the world?s top selling drug. In its complaint, Mylan contended that Ranbaxy is not eligible for that marketing exclusivity because of ?false and unreliable data? about its manufacturing site in Paonta Sahib used in the company?s application for generic Lipitor.
?(US) FDA?s indecision is depriving millions of Lipitor patients access to lower-cost generic Lipitor,? Mylan said in its complaint. It is ?costing the public billions of dollars in savings, and costing generic manufacturers billions of dollars in lost sales.?
Mylan has urged the court to force the US FDA publicly declare whether Ranbaxy?s application ?is tainted by Ranbaxy?s misconduct? and that the application must be denied and the 180-day reward avoided. A victory, Mylan says would let it enter the US market in June, when some of the Lipitor patents expire.
Ranbaxy has maintained in its reply that Mylan’s appeal is based on mere speculation, as its application (ANDA) is yet to get approval from US FDA and is based on the presumption that it would manage to get the requisite approval.