The 180-day exclusivity rule for generic drugs was meant to reward patent challengers-but authorized generics let brand-name companies undercut them. Here's how the law works, why it's broken, and what’s being done to fix it.
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The first generic manufacturer to launch after a patent expires captures up to 90% of the market and retains a dominant share for years due to prescriber habits, pharmacy stocking rules, and patient loyalty-thanks to the Hatch-Waxman Act's 180-day exclusivity.
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