Tag: pediatric exclusivity
Pediatric Exclusivity: How the FDA Extends Drug Market Protection Without Changing Patents
Pediatric exclusivity gives drugmakers six extra months of market protection by blocking generic approvals-even after patents expire. It's not a patent extension, but it's just as powerful.
Pediatric Exclusivity: How the FDA Extends Market Protection for Drugs
Pediatric exclusivity gives drug makers six months of market protection by blocking generic approvals-not extending patents. It incentivizes pediatric studies. Learn how this FDA tool works and why it matters for drug development.