Tag: Paragraph IV certification

Patent Litigation and Generic Entry: Why Disputes Delay Affordable Drug Launches

Patent Litigation and Generic Entry: Why Disputes Delay Affordable Drug Launches

Patent litigation routinely delays generic drug launches by years, costing patients billions. Despite FDA approval, legal battles, pay-for-delay deals, and patent thickets keep cheaper drugs off the market. This is how the system works-and why reform is urgently needed.