Welcome to the Paragraph Four Report®.   Here, we bring some clarity to the confusion surrounding the world of generic drug approval process, Paragraph IV certifications, and patent challenges. There is an ever-increasing degree of activity in this area which means that things have gotten a bit more difficult to understand.

As with most things we do at The Paragraph Four Report, we are keeping this section simple. While it discusses the rules and reasons why and it remains accurate, there may be the exception to the exception that we won’t explore. But you will get the idea.  

Though you can click on any of the following topics to begin, we suggest that you go in order if you are new to all of this.