Another day, another Lipitor generic story: This time, it's California pharmacies suing Pfizer ($PFE) and Ranbaxy Laboratories, which has exclusive rights to sell a copycat version of the drug beginning Nov. 30. In an antitrust complaint, the pharmacies say the drugmakers engineered a patent settlement that kept generic Lipitor off the market in the U.S. in exchange for earlier launch of copies in foreign markets.
Meanwhile, Ranbaxy posted third-quarter results--the gist is a $93.97 million loss--without addressing the question of whether it will be able to launch a generic copy of Lipitor on schedule. The company has longstanding problems with the FDA requiring closure before its generic version can win agency approval. "We have no comments to offer (on the Lipitor launch)," a Ranbaxy spokesman told Reuters. Furthermore, "Ranbaxy continues to co-operate and negotiate with the U.S. FDA and the Department of Justice for a comprehensive settlement to address its regulatory issues," the Indian company said in a statement.
There's no question Pfizer reaps major benefits for every extra month without generic rivals for Lipitor. The pharmacies say in their lawsuit Pfizer eked out an extra $18 billion through its patent settlement with Ranbaxy. That 2008 settlement gave Ranbaxy that Nov. 30 launch date, and with first-to-file status, Ranbaxy would have 6 months as the only independent generic rival to the best-selling cholesterol drug. Watson Pharmaceuticals ($WPI) has the right to sell an authorized generic version.
"Pfizer believes this suit has no merit and we are confident that the Lipitor patent settlement with Ranbaxy is appropriate," company spokesman Chris Loder told Bloomberg. "We view the suit as nothing more than an attempt to extract money." The pharmacies are seeking disgorgement of Lipitor profits from the deal they consider unlawful, plus triple damages.