Cadila Healthcare Ltd. has received US Food and Drug Administration (FDA) approval to sell the generic version of Pfizer Inc.'s popular post-organ transplant drug Rapamune in the United States (US) with a six-month exclusivity. The company will start selling the medicine in US immediately. Pfizer's patent on the drug expired on 7 January 2014.

Cadila was the first generic drugmaker to file an application for marketing its version of Rapamune, which entitles it to a six-month exclusivity in the market under US generic drug laws. During this period it can sell the copy drug at a price not significantly lower than the patent owner's price.