Report: Ranbaxy to launch generic Lipitor at end of November

NEW YORK — Ranbaxy Labs will launch its generic version of the world's top-selling drug as originally planned, according to published reports.

Citing Japan's Nikkei daily, Reuters reported that Gurgaon, India-based Ranbaxy would launch a generic version of Pfizer's cholesterol medication Lipitor (atorvastatin) at the end of November.

Though the November launch had long been anticipated, speculation arose that Ranbaxy would have to sell rights to the drug due to manufacturing problems in India that had led the Food and Drug Administration to ban imports of some of its products from there.

But with the launch back on track, a generic version of Lipitor will be a major prize for Ranbaxy. According to IMS Health, the branded version of the drug had U.S. sales of $7.2 billion last year. Under the Hatch-Waxman Act of 1984, as the first company to win approval of a generic version of Lipitor, Ranbaxy will have the exclusive right to market the generic for 180 days, in direct competition with Pfizer.

Still, the company is expected to face additional competition in the form of an authorized generic marketed by Watson Pharmaceuticals. An authorized generic is the branded drug sold under its generic name at a reduced price, usually through a third-party company, as a way of creating a third front of competition against the actual generic.