The composition is public, and needs to be disclosed when patented. In order to get FDA approval for a generic drug, you need to show that it performs as well a

The composition is public, and needs to be disclosed when patented. In order to get FDA approval for a generic drug, you need to show that it performs as well as the actual drug (not really, but that's a different issue [0]). In order to do that, you need to have samples of the actual drug. [0] http://fortune.com/2013/01/10/are-generics-really-the-same-as-branded-drugs/ http://fortune.com/2013/01/10/are-generics-really-the-same-a...