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Tag: 180-day exclusivity
Pharmacy
180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Markets
- Sterling Hargrave
- Feb 7, 2026
The 180-day exclusivity rule was meant to reward generic drug companies for challenging patents - but authorized generics let brand-name makers undercut them. This legal loophole is changing how drugs reach patients and who profits.
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.