Added by Savannah Mitchell • Updated Jun 28, 2019 at 4:53 PM

Patent + Regulatory systems

Here is a link to a nice chart that shows how some of the patent and regulatory systems interact. It is not exhaustive by any means:

https://i0.wp.com/www.drugpatentwatch.com/blog/wp-content/uploads/2018/12/Figure-1-Comparing-protection-against-competition-for-a-new-drug-sponsor-....gif?zoom=1.5&fit=1000%2C709&ssl=1

It uses one US patent filing to simplify things, and refers to only the US regulatory filings and market approval (IND - Investigational New Drug Application; NDA - New Drug Application).

It also assumes drug approval happened on the same day in US, CA, EP and JP (which would never happen). They are just showing the other countries to give an example of some of the other exclusivities. Regulatory exclusivity is not tied to patents. It begins upon marketing approval of an eligible drug product. Not all products will be eligible.