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Tag: 180-day exclusivity

Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

15 December 2025 · 15 Comments

Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

The first generic drug company to file a patent challenge gets 180 days of exclusive market rights under U.S. law. This rule was meant to speed up affordable drugs-but it’s been exploited, delaying competition for years. Here’s how it works, who profits, and why it’s being changed.

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