Tag: generic drug delay

How the 30-Month Stay Delays Generic Drug Approval Under Hatch-Waxman

by Derek Carão on 3.01.2026 Comments (15)

The 30-month stay under the Hatch-Waxman Act delays generic drug approval by automatically blocking FDA approval when brand companies sue over patents. This legal tool, meant to balance innovation and access, often extends monopolies and costs consumers billions annually.