Exclusivity Rules

180-Day Exclusivity: When Everybody's Special, Nobody's Special

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
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NCEs+Old Antibiotics: The Wrong Combination?

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
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Court Drops Depth Charge on Submarine Exclusivity

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
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Orphan Drug Designation: The Gift That Keeps on Giving

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
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Categories: Orphan

Submarine Exclusivity: Unseen Risk for 505(b)(2) Applications

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
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Exclusivity Rules Blog — Welcome

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… Read More
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Categories: Other

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