The 30-Month Stay: How Patent Litigation Blocks Generic Drug Approval
The 30-month stay delays generic drug approval when brand makers sue over patents. Learn how this Hatch-Waxman provision works, its economic impact, and proposed reforms.
FDA's 180-Day Exclusivity: How First Generic Applicants Gain Market Advantage
FDA's 180-day exclusivity rewards the first generic drug maker to challenge a patent, but delays and deals have turned it into a tool for market control. Here's how it works - and why reform is coming.