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Tag: Paragraph IV certification
Pharmacy
Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity
- Gareth Wycliffe
- Dec 10, 2025
The first generic drug filer gets 180 days of exclusive market rights under the Hatch-Waxman Act. This rule was meant to lower drug prices-but loopholes let companies delay competition. Here’s how it works, who benefits, and why reform is overdue.