Don’t Test Me! FDA Applies “Deemed Triggered” Regulation to 180-Day Generic Drug Exclusivity

By Kurt R. Karst — “Don’t test me!”— that’s a warning that I, along with my younger brother, Erik, heard more than once from our parents while growing up.  The warning would come up from time to time—but particularly during our teenage years—when teenagers do what they sometimes do: challenge authority or just forget some responsibility.  (Of course, I now recognize and understand this with two teenage boys in the hopper and a tween daughter not too far away from true teenage status.)  In any case, hearing “Don’t test me!” from my parents meant that they were serious and more than willing to impose a penalty for the infraction identified if it happened.  FDA has thrown down a similar gauntlet in the 180-day exclusivity arena. Over the years here at the FDA Law Blog when putting together and updating our popular 180-Day Exclusivity Tracker (which tracks all grants and forfeitures of Paragraph…

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