Tag: Hatch-Waxman

Pediatric Exclusivity: How the FDA Extends Market Protection Without Touching Patents
Pediatric Exclusivity: How the FDA Extends Market Protection Without Touching Patents
Mar, 20 2026 Pharmacy and Drugs Caspian Lockhart
Pediatric exclusivity gives drug companies six extra months of market protection by delaying generic approvals-even after patents expire. It's not a patent extension, but it's just as powerful.