Countdown to 2011: A big year for generics

The world of generic drugs has a big year ahead of it. Actually, it has a few big years ahead of it. But 2011 in particular carries a certain symbolic value as the year in which Pfizer, the world’s biggest drug maker, loses control of its patent for the cholesterol-lowering drug Lipitor (atorvastatin calcium), the world’s top-selling drug. While it’s not a moment quite as dramatic as the fall of the Roman Empire or the Soviet Union’s launch of the Sputnik satellite — Pfizer will continue to be the world’s biggest drug maker for the foreseeable future, and it likely will continue to perform well even if it loses that position — it marks a sort of apogee of the evolution of the generic drug industry.

To be sure, Pfizer stands to lose quite a lot in sales when Gurgaon, India-based Ranbaxy Labs — now a subsidiary of Japan’s Daiichi-Sankyo—begins marketing its cheaper, generic version of Lipitor next year. Under the Hatch-Waxman Act of 1984, Ranbaxy will get 180 days in which to market its version, after which the drug will become fair game for any generic company that can win approval for a version of its own, and the price of generic Lipitor will dip even further, leading to a commoditization of the market for it.

New generic launches — outlook remains robust