Tag: Hatch-Waxman

180-Day Exclusivity and Authorized Generics: Legal Risks and Market Impact

Dec, 15 2025| 1 Comments

The 180-day exclusivity rule was meant to reward generic drug makers who challenge brand patents - but authorized generics let brand companies undercut them during that window, undermining competition and reducing revenue. Here’s how the law works, why it’s broken, and what’s being done to fix it.