Back in 2002, Ranbaxy was the first generic to file for Food and Drug Administration approval of its version of Lipitor, which brings in more than $10 billion a year for Pfizer. Pfizer, of course, sued to block the Ranbaxy version. In 2008, before court rulings on the validity of the five Pfizer patents that protect Lipitor, Pfizer and Ranbaxy reached a settlement under which the generic agreed not to market its version of the drug until November 30, 2011. But because Ranbaxy was the first generic to apply for FDA approval, it gets a 180-day exclusivity period, under the Hatch-Waxman Act, once it begins selling its version of Lipitor.
In other words, under Pfizer’s deal with Ranbaxy, all other generic manufacturers are barred from bringing their versions of Lipitor to market until after Ranbaxy’s exclusivity period runs out in 2012. That, however, didn’t sit well with Apotex, which has already begun marketing its own version of Lipitor in Canada. Apotex filed an FDA application to sell its version in the U.S. in 2008. Pfizer promptly sued, eventually claiming Apotex’s drug infringes two Pfizer patents.
