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FDA's 180-Day Exclusivity: How It Helps First Generic Drug Makers Compete

FDA's 180-Day Exclusivity: How It Helps First Generic Drug Makers Compete

The FDA's 180-day exclusivity gives the first generic drug maker to challenge a patent a head start on the market. But loopholes let companies delay launches, costing patients billions. Here's how it works - and why reform is coming.

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Dec 11, 2025 by Zander Fitzroy

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