180-Day Exclusivity: When Everybody's Special, Nobody's Special
September 20th, 2019
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…
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Court Drops Depth Charge on Submarine Exclusivity
August 5th, 2019
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…
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Submarine Exclusivity: Unseen Risk for 505(b)(2) Applications
May 13th, 2019
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…
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