Exclusivity Rules

Scott M. Lassman recently was recognized again by The Best Lawyers in America as one of the leading lawyers in the United States in the categories of FDA Law and Administrative/Regulatory Law. Best Lawyers’ recognitions are based purely on the… Read More

It is very unusual for a Hatch-Waxman exclusivity issue to intersect with a Pixar movie. But a recent viewing of The Incredibles got me thinking about FDA’s 2016 final regulation regarding 180-day exclusivity, particularly its new rule that an ANDA… Read More

For many things in life, details matter. Take cooking, for instance: add the wrong ingredient or combine your ingredients in the wrong order, and you may have an unexpected disaster rather than a prize-winning pie. Trust me, you don’t want to eat a… Read More

On July 22, 2019, the United States District Court for the District of Columbia ruled against the Food and Drug Administration (“FDA”) in a lawsuit challenging FDA’s application of 3-year exclusivity in the context of a 505(b)(2) application. T… Read More

In the world of exclusivity, there is one overarching rule: all good things must come to an end. New chemical entity (NCE) exclusivity expires after five years (sometimes four); orphan drug exclusivity ends after seven years; and even Reference Produ… Read More

Last week, the Food and Drug Administration (FDA) finalized its guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application. The final guidance provides useful tips on the differences between ANDAs and 505(b)(2) applications and the… Read More