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Tag: ANDA
Pharmacy
180-Day Exclusivity: How Patent Law Blocks Generic Drug Entry
- Elara Huxleigh
- Mar 4, 2026
The 180-day exclusivity rule was meant to speed up generic drug access-but often delays it. Learn how patent law, FDA rules, and corporate strategy combine to block affordable medications.
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.