Welcome to the new Exclusivity Rules blog, sponsored by Lassman Law+Policy. As the name suggests, this blog will focus on the complex rules – both written and unwritten – that govern FDA’s exclusivity decisions for drugs and biologics.
The blog will explore both recent developments and past precedents that may have been forgotten but are still relevant and important today. And while Exclusivity Rules will be sharply focused on exclusivity issues, it will address all types of exclusivity, including NCE, 3-year, orphan, pediatric, 180-day, competitive generic therapy, reference product, and many more. In addition, this blog will address patent certification and 30-month stay issues, which, despite their connection to patents, are really regulatory exclusivity periods.
We hope you find Exclusivity Rules to be an interesting and useful resource. Next up, a topic near and dear to my heart: Submarine Exclusivity!