Lipitor Goes Generic

Pfizer's patent on their "blockbuster" heart drug Lipitor, which has raked in billions, ended yesterday. And already a cheaper generic has been cleared for sale. That news may be a literal lifesaver for people whose insurance did not cover Lipitor.

Ranbaxy Laboratories Ltd. has won approval to sell generic copies of the $10.7 billion cholesterol pill Lipitor in the U.S., threatening Pfizer Inc.’s sales. U.S. Food and Drug Administration clearance for Ranbaxy, India’s biggest drugmaker, followed a dispute over whether the company could produce the copies given questions about its manufacturing plants. A deal to share profits with Teva Pharmaceutical Industries Ltd., a generic-drug maker based in Israel, helped overcome that hurdle.

By federal law a drug patent can last 20 years, but that time is usually shortened by the time between when a patent is granted and when the medication actually hits the market. Many drugs end up having patent protection for about twelve years, although drug makers will sometime make an end-run around that limit by "reformulating" the drug and applying for a new patent.

In nations with shorter or unenforced patent protections, generic or counterfeited copies of many major U.S.-invented drugs are sold at prices far, far below what is seen domestically. Many argue that American drug companies wouldn't bother to pursue innovating treatments were they not guaranteed a long period of exclusive sales.

RELATED: A handful of early HIV drug patents have expired or will shortly. A generic version of Crixivan, which despite its often brutal side-effects surely saved countless lives, is set to debut in May 2012. GSK's controversial AZT fell out of patent in 2005. In July of this year Gilead announced that it would permit overseas production of generic versions of their HIV drugs Viread and Emtriva.