By Peter Loftus Of DOW JONES NEWSWIRES More generic-drug makers have filed for U.S. approval to market generic versions of Pfizer Inc.'s (PFE) blockbuster cholesterol pill Lipitor. New York-based Pfizer disclosed in a regulatory filing Thursday that Dr. Reddy's Laboratories Ltd. (500124.BY) and Kremers Urban Development Co. filed applications with the Food and Drug Administration in October, challenging the validity or asserting non-infringement of three Pfizer patents for Lipitor which are due to expire between 2013 and 2017, including extensions for having studied the drug in children. Dr. Reddy's and Kremers aren't challenging a more crucial patent for Lipitor that's due to expire in June 2011. That patent was the subject of prolonged litigation between Pfizer and generics maker Ranbaxy Laboratories Ltd. (500359.BY), which ultimately ended in a 2008 settlement that's expected to ward off U.S. generic competition for the world's top-selling prescription drug until November 2011. It appears that Dr. Reddy's and Kremers' plans wouldn't jeopardize the Pfizer-Ranbaxy settlement, and Pfizer didn't disclose any intent to challenge their efforts in court. The expected introduction of generic Lipitor in 2011 has pressured Pfizer shares in recent years. Pfizer recently acquired Wyeth for $68 billion partly to help offset the expected blow to sales from generic Lipitor. Pfizer also disclosed Friday it settled challenges to Pfizer's Lipitor patents in Canada in August and September, "on terms we believe are favorable to the company." Pfizer recorded Lipitor sales of $8.26 billion for the first nine months of 2009, down 11% from a year earlier. Sales have been declining due to the availability of cheaper generic versions of other cholesterol drugs such as simvastatin. Separately, Pfizer said Novartis AG's (NVS) Sandoz unit has filed for FDA approval of a generic version of Pfizer's Caduet, which combines Lipitor with hypertension drug Norvasc. Sandoz challenged the validity of Pfizer's patent covering the combination, which expires in 2018, as well as patents for Lipitor expiring between 2013 and 2017. Pfizer said it has filed lawsuits against Sandoz in October in federal courts in Delaware and Colorado, asserting infringement of the 2018 combination patent for Caduet. Pfizer's Caduet sales declined 11% to $392 million for the first nine months of 2009. Pfizer also has settled challenges to a patent for Vfend, an anti-fungal drug that had $555 million in sales for the first nine months of 2009. The settlement, reached in October, grants Mylan Inc. (MYL) and Matrix Laboratories Ltd. (524794.BY) the right to market generic Vfend in the U.S. beginning in the first quarter of 2011. The deal is subject to approval by U.S. antitrust authorities, and is limited to the tablet form of Vfend, not the intravenous or suspension forms. -By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
